Recent developments have fueled speculation that some artificial intelligence (AI) systems have attained'sentience.' Sentient AI systems, to paraphrase philosopher Nick Bostrom, are those that can experience 'qualia,' which includes feelings, sensations, and thoughts. This claim is being challenged, but the news has left a trail of excitement in its wake.
Artificial intelligence (AI) generated content has posed significant challenges to the current Intellectual Property (IP) regime. It is still unclear how far the current IP system, which is predominately based on consequentialist and/or utilitarian approaches, is prepared to accommodate AI generated contents. Furthermore, when it comes to developing countries like Bangladesh with its still premature Judicial system and Artificial Intelligence law, there are numerous ethical and legal issues concerning AI, such as the lack of a regulatory regime, data misuse, bias, and discrimination.
Contents patentable, copyrightable, or designable:
Perhaps the most striking issue at hand is that, because AI creates or invents content based on provided data, IP protection would transform the proprietary right on data, potentially violating data protection laws. Again, one cannot deny the implications of AIs in their current state. As a result, there have been heated legal and policy debates on a number of unresolved issues: To what extent and magnitude might AI-generated contents be patentable, copyrightable, or designable, and if so, who would be the inventor, author, or designer, respectively?
What are the implications of AI-generated content if AI is granted legal personality, with rights and duties?
What are the available legal and policy options for dealing with this new technology?
According to the Hegelian approach to philosophy, the inventor or creator has a legitimate justification to enjoy the results and benefits of such property due to the connection between the work and the person.
The AI or so called sentient computers, on the other hand, cannot be considered the beneficiaries of their labor. Similarly, the ex-ante justification of inventiveness is inapplicable to AI generated content. The romanticism semantic of a "lone genius inventor or creator who invents or creates only if strongly incentivized" does not appear to be well suited to justifying the protection of AI generated contents.
Computers do not create or invent content on their own initiative; rather, they are directed to do so. Furthermore, because computers are value-neutral, AI may produce socially or culturally unacceptable or immoral content, which may contradict the proposition of'social planning theory.' There may be concerns based on the 'free-riding' doctrine, which states that if AI generated contents are not protected, they will be open to copying and undue benefits may be taken by others, which will contradict the deontological justification of the IP regime, just like any other branch of law.
Much has been written about the desirability of such sentience, with debate centered on topics like how sentient AI adds value to society and its role in shaping our understanding of consciousness. Commentators have also attempted to theorize the tenets of responsible sentience by articulating the dangers of such systems.
Legal Risks associated with Sentient systems and Artificial Intelligence law:
Individual privacy is one such risk. Sentient systems, in theory, could act as a patient listener capable of roving conversations with customers. This characterization of such systems animates their interaction with privacy law and necessitates reflection.
While such systems have a wide range of applications, one that has recently received attention is AI-enabled chatbots. This use-case hints at how sentience might be used in the future to make human-machine interactions more personable and meaningful.
These interactions, of course, include personal information. As a result, they are subject to the application of privacy law. However, in the future, coding such systems with sentience makes the operation of such law circumspect and susceptible to disruption. Sentient systems, as opposed to the average bot, can engage deeply with their interlocutors without the need for human intervention.
Prompts to share deeply held beliefs, health information, or financial data are examples of such engagement. Prompts may also encourage people to talk about related people, such as friends or family. This likely aftereffect of sentience may thwart the strict application of privacy law.
Consent dilemma with AI law in Bangladesh:
The dilemma of consent is at the heart of such frustration. Sentient AI systems are likely to alter conversational patterns, undermining privacy law's notice-and-consent provisions. In India, for example, the Information Technology Act of 2000 requires entities collecting sensitive personal information — such as financial information, medical history, and sexual orientation — to obtain prior consent before collecting such information.
Entities must also explain to customers why such information is being collected. This purpose effectively limits an entity's data processing activity. The above-mentioned rules require that data collection be limited to the stated purpose or other lawful purposes related to the entity's functions.
However, communicating a strong, well-defined purpose to users will be difficult for entities deploying sentient AI. The AI's novel or meandering conversation patterns may introduce new themes for conversations, rendering consent moot. As a result, convoluted consent tokens and ambiguous purpose statements may dominate the machine-human relationship, causing anxiety in both customers and businesses.
Sentient AI, which is infinitely curious, can create situations in which businesses and regulators must respond with unwavering vigilance. As a result, their consent-and-purpose-bending experiment with privacy law necessitates well-thought-out solutions.
The fundamental right to privacy is not expressly granted in the Constitution. The courts, on the other hand, have incorporated the right to privacy into the following existing fundamental rights:
Article 39 guarantees freedom of thought and conscience; Article 32 guarantees life and personal liberty. These fundamental rights under the Constitution, however, are subject to reasonable restrictions imposed by the State under Article 39(2) of the Constitution.
According to Article 43 of the Constitution, every citizen has the right to the privacy of their correspondence and other means of communication, subject to any reasonable restrictions imposed by law in the interests of the security of the State, public order, public morality, or public health.
Furthermore, the Constitution states that no one shall be deprived of life or personal liberty except in accordance with legal procedures. As a result, judicial intervention is very much possible in Bangladesh's legal system, and such privacy is subject to the application of lawful interception.
The Technology Act and the Digital Security Act address issues such as wrongful disclosure, personal data misuse, and breach of contractual terms relating to personal data.
The Act on Technology
The Technology Act provides legal recognition for electronic certificates and transactions conducted through electronic data interchange, as well as other forms of electronic communication that involve the use of alternative or paper-based methods of communication and information storage to facilitate electronic filing of documents with government agencies.
The Technology Act imposes liability on any person or entity that possesses, deals with, or handles any sensitive personal data or information. Furthermore, the Technology Act requires the implementation and maintenance of reasonable security practices to avoid wrongful loss or gain by the owner of such data, as detailed below.
The Government of Bangladesh ('the Government') has the authority to intercept data under certain conditions under the Technology Act. Section 46 of the Technology Act, in particular, which is an exception to the general rule for maintaining information privacy and secrecy, provides that the government may intercept data if it is satisfied that such interception is necessary in the interest of:
the state's sovereignty, integrity, or security;
friendly relations with foreign states;
public order; preventing incitement to commit any cognizable offence relating to the above; or investigating any offence.
The Government may, by order, direct any agency of the appropriate government authority to intercept, monitor, or decrypt, or cause any information generated, transmitted, received, or stored in any computer resource to be intercepted, monitored, or decrypted.
Section 46 of the Technology Act gives the government the authority to intercept, monitor, or decrypt any information, including personal information, in any computer resource. The government may require disclosure of information if it is of such a nature that it should be disclosed in the public interest. This category may include information about anti-national activities that violate national security, violations of the law or statutory duty, or fraud.
Under the aforementioned conditions, the government-appointed controller can direct a subscriber to extend facilities to decrypt, intercept, and monitor information. Section 69 of the Technology Act covers interception, monitoring, and decryption for the purpose of investigating cybercrime. The controller may declare any computer, computer system, or computer network to be a protected system and authorize applicable persons to secure access to protected systems by publishing a notice in the Bangladesh Government Press or in the electronic gazette.
The Digital Security Act and Artificial Intelligence law
The Digital Security Act was passed to ensure national data security and to create laws governing data crime detection, prevention, suppression, prosecution, and other related issues. The relevant provisions of the Digital Security Act are listed below.
According to the Digital Security Act, if any data or information published or propagated in digital media about a subject under the Director General's purview threatens data security, the Director General may request that the relevant regulatory authority remove or block said data or information as appropriate.
The Telecommunications Act of 2001
The Telecommunications Act of 2001 ('the Telecom Act') is the only law that governs two-party electronic communication. According to Section 67(b) of the Telecom Act, no one shall intercept any radio communication or telecommunication, nor shall any intercepted communication be used or divulged, unless the originator of the communication or the person to whom the originator intends to send it has consented to or approved the interception or divulgence. Such an act is punishable by imprisonment for a maximum of three years or a fine of BDT 300,000 (approx. €3,153), or both.
Under Section 97(Ka) of the Telecom Act, the Government may empower certain authorities (e.g., intelligence agencies, national security agencies, investigation agencies, or any officer of any law enforcement agency) to suspend or prohibit the transmission of any data or voice call, as well as record or collect user information relating to any subscriber to a telecommunications service, on the grounds of national security and public order.
This broadly drafted provision includes intercept capabilities. The relevant telecoms operator must fully support the empowered authority in exercising such powers. The Telecom Act makes no mention of time limits on these powers. As a result, an interception may last as long as the agency carrying out the interception desires.
The Government may require a telecommunications operator to keep records relating to a specific user's communications under the broad powers granted in Section 97(Ka) of the Telecom Act on the grounds of national security and public order. However, when deciding whether to grant a retention request, the relevant government agency must consider the operator's technical resources and ability to retain information.
Under Section 96 of the Telecom Act, the government may seize any telecommunication system and all arrangements necessary to operate it in the public interest. It may retain such possession for any period of time and keep the operator and their employees employed full-time or for a specific period of time for the purpose of operating such apparatus or system. However, the government is required to compensate the owner or person in control of the radio apparatus or telecommunications system that it takes over.
Except for authorised persons as defined in Section 97(Ka) of the Telecom Act (security agencies), anyone who taps or intercepts telecommunication between two persons without their permission commits an offense.
According to Section 68 of the Telecom Act, the following acts are considered offenses if committed by an official of a licensee while performing their duties: use any telecommunication or radio apparatus with the intent of obtaining any information relating to the sender or addressee, or the content of a message sent by telecommunication or radio communication, unless the Bangladesh Telecommunication Regulatory Commission ('BTRC') has authorized that employee or operator to receive the message; except as required by the BTRC or a court, disclose any information
The 1872 Contract Act
The Contract Act of 1872 can be used to address the issue of data protection, which has traditionally been governed by the contractual relationship between parties. Parties are free to enter into contracts to define their relationship in terms of personal data, personal sensitive data, data that may not be transferred out of or into Bangladesh, and the manner in which the same is handled.
The 2009 Consumer Rights Protection Act
According to Section 52 of the Consumers' Rights Protection Act, 2009, anyone who violates any prohibition under any law currently in force by doing any act that is detrimental to the life or security of a service receiver is punishable by imprisonment for a period not exceeding three years and/or a fine not exceeding BDT 200,000 (approx. €2,070). According to Section 53, any service provider who, through negligence, irresponsibility, or carelessness, harms or kills the service receiver's finances or health, or causes death, is subject to imprisonment for a period not exceeding three years and/or a fine not exceeding BDT 200,000 (approx. €1,980). Furthermore, the consumer may be entitled to compensation.
These provisions implicitly impose responsibility on the person or entity that possesses, deals with, or handles any sensitive personal data or information for the consumer to implement and maintain reasonable security practices in order to avoid wrongful loss or gain to the owner of such data.
The Criminal Code
The Penal Code of 1860 ('the Penal Code') can be used to effectively prevent data theft. The Penal Code punishes misappropriation of property, theft, and criminal breach of trust with imprisonment and a fine. Although the Penal Code only applies to movable property, it has been defined to include corporeal property of "every description," except land and things permanently attached to the earth. As a result of their movability, computer databases can be protected under the Penal Code.
The 2000 Copyright Act
The Copyright Act of 2000 (the "Copyright Act") safeguards intellectual property rights in literary, dramatic, musical, artistic, and cinematographic works. The term "literary work" also includes computer databases. As a result, copying a computer database or copying and distributing a database constitutes copyright infringement, for which civil and criminal remedies are available. However, the Copyright Act makes it difficult to distinguish between data protection and database protection. Data protection is concerned with protecting individuals' informational privacy, whereas database protection is concerned with protecting the creativity and investment put into the compilation, verification, and presentation of databases.
The Data Protection Act Legislation
The Government intends to submit the Data Protection Bill ('the Bill') to the National Parliament for enactment, and in that regard, an internal draft of the Data Protection Act was circulated in November 2020. While the content of the law has not been made public, there have been a number of indications from the government about the new dimensions that the Bill will introduce.
The Bill is intended to define data controllers (as opposed to data users) as individuals who collect, process, use, share, or otherwise process data within Bangladesh or data of Bangladesh residents. It has been reported that it will cover certain aspects of the General Data Protection Regulation (Regulation (EU) 2016/679) ('GDPR'), specifically the data quality principle, use limitation principle, and security safeguards principle, as opposed to the collection limitation principle and accountability principle, which are addressed to some extent by the Digital Security Act.
Another new requirement is to push for data localisation, or data sovereignty, as the Bill states that Bangladeshi citizens' personal data must remain in the country. The Bill specifically states that every data controller must keep at least one serving copy of such data within the geographical boundaries of Bangladesh.
The public sector and Artificial Intelligence law
There is no separate law governing this matter. However, under the Digital Security Act, anyone who commits or aids and abets in committing an offence via computer, digital device, computer network, digital network, or any other digital medium will face a term of imprisonment of up to 14 years or a fine of up to BDT 2.5 million.
The issues raised foreshadow a sliver of the regulatory scrutiny that sentient systems will face. Addressing this gaze necessitates the adoption of two entity-level attitudes. To begin, because compliance is trite, entities may consider investing in processing techniques that maintain data-light sentient systems.
Second, entities must recognize that privacy is not synonymous with privacy law. Privacy is an interdisciplinary goal; organizations must empower their engineers to determine its technical boundaries.
Entities deploying such systems may, for starters, articulate a processing pipeline for them. This will be done in accordance with their privacy policies. The pipeline must include the following information: the system's role, the location of its servers, the analytics and third-party tracking tools that the system may use, and the risks that its data processing activities may cause.
Concurrently, businesses must intensify efforts to recognize the wide range of functions that their sentient system may perform. This data can be used to set hard limits on data processing. They can also be used to identify safe harbor use cases; for example, sentient systems processing data to revive languages may be exempt from certain privacy law provisions.
Transparency and law regards to Artificial Intelligence:
The common thread running through these recommendations is transparency. Sentient systems' commitment to openness is likely to serve as an antidote to the concern that they'monitor' individuals by collecting personal data. Adopting a framework that operationalises openness and fairness in personal data processing may assist entities in effectively navigating privacy law.
The 2030 Agenda was incorporated into Bangladesh's seventh Fiscal Year Plan (2016-2020). This is an excellent opportunity to carry out the 2030 agenda while reflecting the needs of the SDGs in the national plan. To advance, the Bangladesh government, NGOs, philanthropists, tech companies, and organizations that collect or generate large amounts of data will need to take decisive action. There are two major issues that must be addressed: data accessibility and a scarcity of talent capable of improving AI capabilities, improving models, and implementing solutions.
AI can play critical roles in addressing the challenges of the SDGs. McKinsey Global Institute has identified approximately 160 SDG cases where AI can be used to solve problems. Bangladesh is committed to using emerging Artificial Intelligence to solve the most pressing SDG problem.
To comprehend the upcoming challenges of artificial intelligence, an ideal procedure for applying AI in various sectors is required. We have identified seven national priority sectors.
Public service delivery, manufacturing, agriculture, smart mobility and transportation, skill & education, finance & trade, and health are among them. We have identified scopes and recommended actions for each of the sectors. Taking into account all of the recommendations from various sectors and challenges, we identified six strategic pillars for AI in Bangladesh and developed a development roadmap for the pillars in order to establish a sustainable AI Ecosystem and Artificial Intelligence law in the country. Bangladesh's six strategic Artificial Intelligence pillars are as follows:
i) research and development,
ii) AI workforce skilling and reskilling,
iii) data and digital infrastructure,
iv) ethics, data privacy, security, and regulations,
v) funding and accelerating AI start-ups, and
vi) industrialisation for AI technologies. Aside from a strategic brief, each strategy includes a road map, action plan, related stakeholders, and lead ministries.
Anyone can see the broader strategy steps planned for Bangladesh over the next five years in that summary roadmap given by the goverment. Then the country can consider our current readiness in terms of infrastructure, awareness, resource pool, social and legal challenges, and other pertinent issues when developing the road map.
Deefakes and Artificial Intelligence law in Bangladesh:
Deepfakes are fake media in which a person's likeness in an existing image or video is replaced with someone else's. While the act of faking content is not new, deepfakes use powerful machine learning and artificial intelligence techniques to manipulate or generate visually and audibly deceptive content. Deep learning is used to create deepfakes, and the main machine learning methods involve training generative neural network architectures such as autoencoders or Generative Adversarial Networks (GANs).
Deepfakes have received widespread attention for their use in the creation of child sexual abuse content, celebrity pornographic video, revenge porn, fake news, hoaxes, bullying, and financial fraud. This has prompted both industry and government to respond by detecting and limiting their use.
How does deep fake in Artificial Intelligence work?
AI technologies are used to create a deepfake. A program is taught to replace or synthesize faces, speech, and emotions. It is used to imitate an action that a person did not commit.
As a result, it is clear that Deepfake is beneficial to the media and film industries. It can be a great tool for creating content and making films. However, it is used to create pornography, financial fraud, fake news, fake videos, bullying, and so on. It is obvious that this is a technology with few advantages and many disadvantages. It causes a slew of major issues for humanity. Law does not evolve at the same rate as technology. Nowadays, technology is rapidly evolving.
However, the development of law is extremely slow. As a result, technology easily wins the race. In Bangladesh, there is no specific law that deals with deepfake-related crimes. However, we can use existing laws to help us prevent this type of crime. I'll go over these laws later.
Copyright infringement and Artificial Intelligence law:
World Intellectual Property Organization (WIPO) draft issue paper on AI and Intellectual Property. However, copyright alone cannot prevent deep fake. Because the victims are not the owners of these videos and photographs. Section 72 of the Bangladesh Copyright Act-2000 defines certain acts that do not violate copyright. This is a lengthy list. Unfortunately, the creator of the deepfake video or images has copyright protection. Victims is not protected by copyright. As a result, the victim has no legal recourse against the creator of the deepfake video and images. As a result, it is clear that using Copyright Law to take legal action against the wrongdoer is extremely difficult.
Law Against Defamation and Artificial Intelligence law:
Another avenue for legal action against deepfake crime is through a defamation case. However, in Bangladesh, defamation is used incorrectly.
According to Section 499 of The Penal Code 1860, "Whoever, by words either spoken or intended to be read, or by signs or by visible representations, makes or publishes any imputation concerning any person intending to harm, or knowing or having reason to believe that such imputation will harm, the reputation of such person, is said to defame that person, except in the cases hereinafter excepted."
Section 500 of the Penal Code 1860 states that "whoever defames another shall be punished with simple imprisonment for a term which may extend to two years, or with fine, or with both."
However, in Bangladesh, the majority of defamation cases are filed solely for harassment. As a result, the dismissal rate of defamation cases in lower courts is very low. However, under Section 198 of the Criminal Procedure Act of 1898, any aggrieved person may file a case of defamation.
Another law exists to prevent the misuse of defamation-related crime. That is the 2018 Digital Security Act. However, this law will not prevent the abuse of the defamation crime. As a result, we must strengthen our defamation laws.
Data protection legislation and Constitution in Bangladesh:
We have no data privacy or data protection laws, which is a harsh reality. Every person has the right to privacy under Article 33(b) of our Constitution. If this right is violated, he or she may file a case in the High Court Division pursuant to Article 102. (1).
According to Section 7 of the Right to Information Act of 2009, everyone has the right to keep his or her data safe. Nobody is going to publish his data. Anyone or any authority has no right to access his data. The provisions of The Digital Security Act 2018 can be used to prevent the misuse of personal data. However, these provisions are insufficient.
Pornography Regulations Act and Digital Security in Bangladesh:
The majority of Deepfake's videos are pornography or revenge porn. The majority of the victims in this case are women. The Pornography Control Act of 2012 can be of assistance. Section 8 of the Pornography Control Act of 2012 severely restricts pornography with a wide range of penalties. Section 8 (1) makes any act capturing video or still pictures of sexual intercourse or behavior exposing sexual sensation, with or without consent of parties in sexual interaction, punishable by imprisonment for a maximum of 8 years and a fine of 2 lac taka.
Making pornographic videos with minors is a major offense punishable by ten years in prison and a fine of five lac taka under Section 8(6).
AI is not only producing patentable products, but it has also begun producing potentially copyrightable works such as newspaper articles, songs, poems, and books, which are obviously creative and artistic in nature. For example, the Flow Machine developed by a team of Sony researchers can compose music; another machine, Mubert, which has been dubbed "the world's first online music composer," can continuously produce music in real time.
This leads us to the obvious questions: Is the creation of AI protected by intellectual property? Who owns the copyright to such a creation? Is it a breach of IPR ethics? These are increasingly important questions these days. There are numerous debates about who created AI and who owns it.
It should be noted that, as an extension of the Berne Convention (1971), only computer programs and data compilations have been protected as copyrightable works under Articles 4 and 5 of the WIPO Copyright Treaty and Articles 10(1) and 10(2) of Trade Related Aspects of Intellectual Property Rights (TRIPs). There is no mention of AI protection in these treaties.
In this regard, an intriguing example can be found in Naruto's case (Naruto v. David John Slater et al, No. 3:2015-cv-04324,9th Cir. ), in which a monkey took a'selfie.' When a photographer complained about the monkey's'selfie,' the US Copyright Office stated that "the Copyright Office would not register works produced by animals or machines."
It even went on to say, "To qualify as a work of 'authorship,' a work must be created by a human being," which was not previously mentioned in the copyright law, and the term 'author' was never defined in this law. In contrast, the European Union (EU) has proposed in a draft paper that robots powered by AI be given a "special legal status."
According to the paper, such a robot must abide by basic 'civil laws.' The EU's interpretation is somewhat acceptable, but the US' refusal to grant copyright for non-human creation raises additional questions, such as who would own the rights to an AI creation. Some articles argued that these issues could be resolved through agency law or that the person in charge of the AI should be granted copyright. Other arguments suggest that the issue of co-authorship be considered whenever an AI creation is involved.
However, many countries' laws are deficient in terms of AI, so excluding AI from copyright law is not the ultimate solution. This is not the way to approach AI development. To address this difficult issue, more global attention and consensus are required.
WIPO Copyright Treaty and the TRIPs agreements:
According to the WIPO Copyright Treaty and the TRIPs agreement, there is currently no clear definition or mention of protection in international treaties. The WIPO Worldwide Symposium on Intellectual Property Aspects of AI, held at Stanford University from March 25 to 27, 1991, was strangely silent on many important issues.
A careful reading of the symposium paper reveals that it was more concerned with defining AI than with finding a way forward to address the issues raised by IP rights. In fact, current laws, both at the national and international levels, are inadequate to address this issue.
Some attendees at the symposium argued that because software is protected by copyright laws, AI work should be treated similarly. However, if humans claim ownership of an AI creation, they must also accept responsibility for AI infringement. We now live in a technologically magical society. It is increasingly controlling our daily lives and will continue to do so in the future as AI creations advance.
AI is advancing at such a rapid pace that current legal systems are incapable of dealing with it. As a result, the international community must consider the potential legal and ethical implications. "The short-term impact of AI depends on who controls it; the long-term impact depends on whether it can be controlled at all," Stephen Hawking once said.
Given the significance of the new thinking on AI creation and Hawking's prediction, the WTO and WIPO should give this issue careful consideration. As AI becomes more difficult to distinguish from human creativity, the legal issues surrounding authorship are bound to become more complicated in the coming years.
Numerous challenges with Artificial Intelligence law and Deep Fake:
There are legislative barriers to protecting AI-generated inventions, particularly with regard to human inventorship requirements, prior arts, examination of inventive steps, and novelty. AI-generated inventions pose numerous challenges, including determining what constitutes "prior art" for machine-generated inventions. Is it possible for ordinary skilled people, such as patent examiners, to locate 'prior arts' produced by sophisticated machines?
Do sophisticated machine AI examiners, rather than human patent examiners, need to be used to search for 'prior art'? Furthermore, because inventive steps are judged on 'non-obviousness,' which implies the gap or improvement between the proposed invention and existing 'prior arts,' such differences would be difficult to measure by a person with ordinary skill in the relevant art. Furthermore, computer-generated claims may be designed in such a way that they obstruct future advances in knowledge.
Another point worth discussing is the requirement for human inventorship in a patent application. Even though the EU approach of 'first to file' justifies non-examination of the inventor in the true sense, failure to meet the formal requirement of human inventorship will result in patent application rejection. In contrast, the US approach of 'first to invent' requires disclosure of the inventor by definition, or it will face EU-style consequences.
A similar concept can be found in the copyright system, where human authorship is required and thus AI generated works are not protected by copyright.
An analogous argument can be made in line with the ratio of the Famous Monkey Selfie Case (Naruto v Slater), in which the US Court did not allow authorship to Monkeys despite selfies being taken independently by Monkeys who clearly had independent thinking abilities. The jurisprudence of the Infopaq Case (Infopaq International A/S v Danske Dagbaldes Forening) in the European Union may also exclude AI generated works from copyright protection.
The court ruled in this case that copyright is only granted to original works, and that the originality must be stamped with the "author's personality." Similar difficulties may be encountered in AI-generated designs.
As a result, there is ambiguity, a lack of legal precision, and policy uncertainty regarding the intellectual property protection of AI generated contents. Policymakers, including relevant stakeholders in digital Bangladesh, should consider potential legislative and policy options to protect AI industry investments and promote creativity and innovation in this burgeoning sector.
Are you intending to know more of Cyber Law and Artificial Intelligence law in Bangladesh?
Employment termination law under the Labour Act 2006:
In Bangladesh, either the employer or the worker may terminate an employee's employment. There are multiple ways in which it can take effect. In sections (20-31) of the Labor Act of 2006, the procedure for terminating an employee's employment is outlined in detail.
Employment termination law in Bangladesh
Causes for dismissal:
May an employer terminate an employee for any reason, or is "cause" required? How does the applicable statute or regulation define cause?
In accordance with sections 23 and 24 of the Labour Act, an employer may terminate an employee who has been convicted of a criminal offense or found guilty of misconduct.
In addition, under section 26, an employee may be terminated without cause by providing the prescribed notice or pay in lieu. Under section 20, a worker may be terminated due to redundancy. In addition, according to section 22, a worker may be let go for reasons of physical or mental incapacity or ongoing ill-health certified by a registered medical practitioner.
Notice : Must termination be communicated prior to dismissal under Employment termination law? May an employer substitute pay for notice?
According to section 23 of the Labour Act, a worker may be terminated (for insubordination or a criminal offense) without notice or pay in lieu of notice. A permanent worker must be given 120 days' notice for termination under section 26, whereas a temporary worker must be given 30 days' notice (if he or she is a monthly rated worker) and 14 days' notice (if he or she is an hourly rated worker) for termination under section 26. (for other workers).
The employer may, however, terminate any employee without notice by paying wages in lieu of notice. If the employee has been continuously employed for at least one year, they are entitled to one month's notice or wages in lieu of notice. For dismissal, no prior notice is necessary.
In what situations may an employer terminate an employee without notice or payment in lieu thereof?
An employer may terminate an employee without notice or payment in lieu of notice if the employee has been convicted of a felony or found guilty of misconduct.
Separation pay:
Exists legislation establishing the right to severance pay upon employment termination? How is separation pay computed?
If an employee is fired for theft, misappropriation, fraud, or dishonesty in connection with the employer's business or property, or for disorderliness, riot, arson, or property damage in the workplace, he or she is not entitled to severance pay.
In accordance with subsection 23(3) of the Labour Act, if a worker with at least one year of continuous service is removed under extenuating circumstances rather than being terminated for criminal conduct or misconduct, he or she is entitled to 15 days' wages for each completed year of service. Nevertheless, a terminated employee is entitled to other benefits under the Labour Act, as applicable (such as provident fund, workers' profit participation fund, and welfare fund).
If a permanent worker's employment is terminated pursuant to section 26 of the Labour Act, he or she is entitled to 30 days' wages for each completed year of service or gratuity (if any), whichever is greater, in addition to any other benefit payable under the Labour Act, as applicable (such as provident fund, etc.).
Under section 20(2)(c) of the Labour Act, a worker who has been in continuous service for at least one year is entitled to 30 days' wages for each year of service or gratuity, whichever is greater. In addition, he or she will be entitled to any other benefits payable under the Labour Act (such as provident fund, etc).
Section 22(2) of the Labour Act stipulates that a worker who has been in continuous service for at least one year is entitled to 30 days' wages for every year of service or gratuity (if any), whichever is greater. In addition, he or she is entitled to any other benefits payable under the Labour Act (such as provident fund, etc).
Redundancy:
According to Section 20 of the Act, any employee may be terminated from the company in the event of redundancy. A worker who has been employed by the company for at least one year must be given thirty days' notice prior to termination. In addition, the worker is entitled to compensation equal to 30 days of wages for each year of service completed.
In accordance with section 21, if a worker is laid off and the employer intends to hire a new worker within a year, the employer must send a notice to the retrenched worker's last known address inviting him to apply for re-employment. If more than one retrenched employee is available, seniority in the previous service shall be given preference.
Section 23 discusses the penalties for infractions and convictions. A worker is punished for his or her misconduct and conviction. A worker may be subject to retrenchment, discharge, or termination of service without notice or pay in lieu of notice if he is found guilty of misconduct or committing a crime.
A worker found guilty of misconduct may receive a sanction other than dismissal, such as:
Removal
Demotion to a lower rank.
Stoppage of promotion for a maximum of one year and withholding of increment for a maximum of seven days.
Warning\ fine
The Act constitutes misconduct, specifically:
Wilful disobedience to any lawful order from a superior, whether committed alone or in conjunction with others.
Theft, deceit, and dishonesty
Persistent absence without leave or permission to be absent, absences exceeding ten days.
Habitual late attendance.
Consistent violation of any law, rule, or regulation.
Workplace negligence on a regular basis.
Altering, tampering with, damaging, or destroying an employer's official records.
If an employee who was terminated is exonerated on appeal, he must be reinstated to his original position or appointed to a suitable position. If neither option is feasible, he will be compensated.
In the event of an allegation of misconduct, a committee must investigate the matter, and the employee in question must be shown cause and given the opportunity to defend himself. It should be noted that a worker can be terminated without prior notice in the event of a criminal conviction or misconduct.
Methods of punishment:
According to section 24, no order of punishment may be issued against a worker unless the allegation against him is made in writing, he is given a copy of the allegation and at least seven days to respond, and he is afforded the opportunity to be heard. No order of punishment shall be issued against a worker unless the worker is found guilty after an investigation conducted by a committee comprised of employer and worker representatives and concluded within sixty days. If no disciplinary action is taken against an employee, the employer or manager approves the dismissal.
A worker accused of misconduct may be suspended pending an investigation, unless the matter is pending before a court, and for no longer than sixty days. During the period of suspension, however, a worker must be paid by his employer and receive his full allowance. The suspension order must be in writing and take effect immediately upon delivery to the employee. In the event that a worker is punished, a copy of the punishment order must be provided to the worker in question.
No fine exceeding one-tenth of wages payable to a worker during a wage period may be imposed on any worker, according to section 25's special provision regarding fines.
A worker who is under 15 years old shall not be subject to a fine. No fine imposed on a worker may be collected in installments or more than 60 days after the date it was imposed. Employers are required to record all fines in a prescribed register.
A dismissal without cause
Section 26 permits an employer to terminate a worker's employment for convenience. Under this Section, an employer may terminate the employment of a permanent worker by providing him with a written notice of 120 days if he is a monthly rated worker and 60 days if he is another worker.
In addition, it is impractical to provide notice to the employee; an employer may offer compensation in lieu of notice. In the event of such a termination, the employee must be compensated at a rate of 30 days' pay for each completed year of service or gratuity, whichever is greater.
Resignation of an employee under labour law of Bangladesh:
According to section 27, a permanent employee may resign by providing 60 days' written notice to the employer. In contrast, a temporary worker may terminate his employment by providing 30 days' written notice if he is a monthly rated worker and 14 days' written notice in all other cases. However, if an employee wishes to resign without notice, he may do so by paying the employer an amount equal to the wages for the notice period.
Retirement under labour law of Bangladesh:
Retirement is discussed in Section 28. A worker must retire at the age of 60, and he or she must be compensated for all outstanding obligations. To determine the age of a worker, the date of birth recorded in his or her service book shall serve as conclusive evidence. Any authority may employ a contract-holding retiree if it sees fit.
Under section 28, if an industry is shifted or a sector is permanently closed due to a natural disaster or other disaster beyond human control, the government may determine the employer-employee relations in accordance with rules.
According to section 29, if a worker is a member of a provident fund and is entitled to any benefit from such a fund, including the employer's contribution, he or she is exempt from income tax. He shall not be disqualified from receiving the benefit due to layoff, discharge, dismissal, retirement, removal, or termination of service.
When a worker's employment ends due to retirement, discharge, retrenchment, dismissal, termination, or any other reason, the appointing authority must pay all amounts owed to him within a maximum of 30 working days.
Section 31 stipulates that, at the time of retrenchment, discharge, or termination of service, every employee is entitled to receive a service certificate from his employer.
Section 307 specifies the amount of punishment for violating a provision of Bangladesh labor law when no other provision of law specifies a punishment. Whereas section 310 stipulates that if an employer is punished for the violation of any law, rule, regulation, or scheme of the law, the court may, by written order, impose additional punishment for removing the cause for which the offense was committed.
Dismissal under labour law in Bangladesh:
Due to "Misconduct," an employee may be "Fired." "Dismissal" is defined by Section 2(39) of the Labour Act, 2006 (as amended in 2013) as "the termination of a worker's services by an employer for misconduct."
The following definitions of "Misconduct" from Section 23(4) of the said Labour Act, 2006 (as amended in 2013) may be applicable in this instance:
willful insubordination or disobedience, alone or in conjunction with others, to any lawful or reasonable order of a superior theft, embezzlement, or fraud in connection with the employer's business or property absence without leave for more than ten days riotous or disorderly conduct in the workplace, arson, or any act subversive of discipline
According to Section 24 (1) of Said Labour Act, the following procedures must be followed in the event of a Dismissal:
The charges against him must be documented in writing.
He must be found guilty after an investigation conducted by an Investigation Committee comprised of an equal number of representatives from the Employer and the Workers, with the duration of the investigation not exceeding sixty days. The employer or manager must approve such a dismissal order.
The said section 24 goes on to state in terms Employment termination law:
i)An employee accused of misconduct may be suspended pending an investigation into the charges against him, but such suspension shall not exceed sixty days unless the matter is pending before a court. During the period of such suspension, a worker's subsistence allowance and other allowances, if any, shall be paid by his employer.
ii) A suspension order must be in writing and take effect immediately upon delivery to the employee.
iii) During an investigation, the accused worker may be assisted by any establishment employee nominated by him.
iv) If oral evidence is presented on behalf of a party during an investigation, the opposing party may cross-examine the witness.
v) If, after an investigation, a worker is found guilty and punished under section 23 (1), he is not entitled to wages for any period of suspension, but is entitled to subsistence allowance for such period.
vi) If the charges against the worker are not proven in the investigation, he shall be deemed to have been on duty during the period of suspension for investigation, if any, and shall be entitled to his wages and subsistence allowance for the period of suspension.
When a worker is punished, a copy of the order imposing the punishment must be provided to the worker in question
viii) If a worker refuses to accept any notice, letter, charge-sheet, order, or other document addressed to him by the employer, it shall be deemed that such notice, letter, charge-sheet, order, or document has been delivered to him if a copy of the same has been displayed on the notice board and another copy has been sent to the worker's address as available from the employer's records, by registered post.
ix) When determining a worker's punishment, the employer must consider the employee's prior record, the severity of the misconduct, and his or her achievements and accomplishments during his or her employment.
According to subsection (2) of section 23 of the aforementioned Labour Act, a worker convicted of misconduct may, in lieu of dismissal under subsection (1), be subject to any of the following punishments, namely:
Removal; reduction to a lower post, grade, or pay scale for a maximum of one year Promotion halted for a period not to exceed one year; Withholding of increment for up to a year; fine; suspension without pay and subsistence allowance for up to seven days; reprimand or admonition.
According to section 23(3), a worker who is "removed" as a form of retaliation must be compensated by his employer at the rate of fifteen days for each full year of service if his continuous service is at least one year. Except in cases of theft, embezzlement, or fraud related to the employer's business or property, riotous or disorderly conduct in the workplace, arson, or any act subversive of discipline.
Reinstatement as per employment law in Bangladesh:
"Reinstatement of a dismissed employee pursuant to section 34 of the Industrial Relations Ordinance of 1969 (briefly, the Ordinance).
Mr. Asrarul Hossain, the learned Advocate for the petitioner, the employer, and Mr. Mozammel Huq Bhuiya, the learned Advocate for respondent No. 1, the employee, have been heard. It is not necessary to reproduce the facts of the case in order to dispose of this rule, as it can be disposed of based on the construction of Section 2(XXVIII) of the Ordinance in conjunction with Section 34 of the same ordinance. Respondent No. 1 was employed as a Supervisor by the petitioner, Sonali Bank, at the relevant time; however, he was terminated by the petitioner after an internal investigation into allegations of misconduct.
He had challenged the dismissal order under Section 34 of the Ordinance and was granted the remedy following a thorough hearing. Mr. Asrarul Hossain has referenced section 2 of the Ordinance's definition of a worker or workman.
He argued that a worker who has been terminated or removed from employment and whose termination or removal is unrelated to any industrial dispute cases is not a worker for the purposes of any proceeding under the Ordinance, and therefore cannot file an application under section 34 with the labor court. He has cited a number of court decisions in support of this position, including the Supreme Court's decision reported in 30 DLR 251 and two decisions of this court reported in LEX/BDHC/0101/1975: 28 DLR 160 and 30 DLR 211.
Evidently, Mr. Hossain's argument has merit and must be upheld, as it is now a settled point of law that a dismissed worker, whose dismissal is unrelated to an industrial dispute, cannot file an application under section 34 of the Ordinance, and that his remedy is to file a complaint under section 25 of the Employment of labor (Standing orders) Act, 1965. Consequently, it is evident that the application for reinstatement under section 34 was not maintainable, and that the challenged order of the labor court was void for lack of jurisdiction."
"The respondent was fired from the company for insubordination after a thorough investigation and with the prior approval of the Managing Director, who is the Chief Executive Officer of the company. As the dismissal order was issued as a matter of routine procedure by the Assistant Labour Officer, the High Court Division found nothing wrong with the order and consequently declared the Labour Court's judgment and order to have been passed without legal authority and without legal effect.
Hopefully, the preceding discussion has enabled everyone to comprehend layoffs and their prescribed procedures.
What are the procedural requirements for dismissing an employee in Bangladesh?
Section 24 of the Labour Act specifies the procedure for dismissing a worker, which includes informing him or her of the allegation in writing and providing an opportunity for a hearing. However, by law, no prior approval from a government agency is required.
Under what conditions are employees protected from dismissal in Bangladesh?
Despite being found guilty of misconduct, a worker may be sentenced to any of the following punishments under section 23(2) of the Labour Act in extenuating circumstances:
removal (in which case he or she is entitled to 15 days' pay for each completed year of service, provided that he or she has been in continuous service for at least one year);
reduction to a lower post, grade, or pay scale for a period of no more than one year;
Promotion suspension for a period of no more than one year; withholding of increment for a period of no more than one year; fine; suspension without wages or subsistence allowance for a period of no more than seven days; or censure and warning.
Is there a set of rules in place for mass terminations or collective dismissals?
No.
Are class or collective actions permitted, or must employees assert labor and employment claims individually?
In employment cases, class and collective actions are permitted.
Is it legal in your state for employers to impose a mandatory retirement age? If so, at what age and with what restrictions?
The Labour Act, Section 28(1), establishes a retirement age of 60 years.
How ‘Tahmidur Rahman & TR Barristers in Bangladesh Associates’ helps the Employee/Employer according to Labour Law Provisions of Bangladesh
At TR Barristers in Bangladesh in Gulshan, Dhaka, Bangladesh, the barristers, lawyers and lawyers are highly experienced in dealing with labor disputes. It also has experience in consulting and assisting numerous international clients, in addition to handling various issues related to employment service among domestic clients on a regular basis.
For queries or legal assistance, please reach us at:
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Bangladesh has a population of approximately 180 million, of which approximately 2 million suffer from kidney diseases and an additional half a million suffer from corneal diseases. Although the need for organ transplants to cure a growing number of patients is growing, the culture of organ donation in the United States is not well-established.
Even though Act No. 05 of 1999 was enacted in response to instances of abuse in terms of Organ donation, it is riddled with flaws that defeat the very purpose for which it was enacted. Section 3 in conjunction with sections 2(ga) and 6(1) of Act No. 05 of 1999 provides a very narrow definition of donor, namely "close relative."
This narrow definition of donors in Organ donation exacerbates the already substantial disparity between the demand for and supply of kidneys, resulting in kidney patients dying without transplant.
The large disparity creates a thriving black market for kidneys, which disproportionately affects the poor. According to Global Financial Integrity (GFI) of Washington, many people in Bangladesh, particularly in rural areas, are compelled to sell their organs to settle debts or for brief financial relief. They are poor, uneducated, destitute, and oblivious to the after-sale complications.
Several of them develop chronic health problems. A minority are better off. The brokers minimize the risk of future complications, and sometimes physicians even assure prospective sellers that their kidneys will regrow. Common postoperative complications include infection, persistent pain, fatigue, and impaired function of the remaining kidney.
Provision for exceptional circumstances for Organ Donation Law in Bangladesh
As a result, a provision had to be made for exceptional circumstances in which a donor may not be a "close relative," and "exceptional circumstances" must be defined and/or criteria must be established for their determination. The Act No. 05 of 1999 does not establish a central authority to regulate the removal and use of Organs for Transplantation.
The enactment of Act No. 05 of 1999 was necessitated by the need for such a regulatory body to prevent abuse. In the United Kingdom, one such authority is the Human Tissue Authority (HTA) (UK).
Due to the inadequacies of Act No. 05 of 1999, kidney patients are compelled to travel abroad with donors (who do not fall within the Act's narrow definition of "near relative") for the purpose of Transplantation in violation of the Act; kidney transplant abroad is very expensive compared to the cost of having it done locally and is therefore out of reach for many.
If section 2(4) is further amended, anarchy will ensue in the organ transplantation sector of our nation. Section 7(kha) of Act No. 01 of 2018 establishes the Cadaveric National Committee, which will oversee all cadaveric kidney transplants in Bangladesh. The Government has already formulated (briefly, the Rules of 2018) in accordance with Act No. 05 of 1999 in order to carry out the purposes of Act No. 05 of 1999.
In light of the global trend of increasing the number of organ donors, the high prevalence of kidney disease in Bangladesh, and the vast disparity between the demand for and supply of kidneys in Bangladesh, the court deemed it necessary to obtain the expert opinions of several individuals prior to deciding the Rule Nisi.
Therefore, by order dated 28.08.2019, this Court directed seven prominent experts in the relevant fields to provide their opinions. Accordingly, the experts provided the court with their consolidated written opinion. In the interest of the public, respondent No. 1 will adhere to the opinion of the experts. Moreover, if this Court issues any directives, the government will comply. Consequently, the Rule may be discarded.
Prevalence of kidney disease and the need for organ transplants in Bangladesh:
There is no study in Bangladesh that estimates the prevalence of kidney disease and the need for organ transplants. However, some estimates indicate that at least 20 million people in Bangladesh suffer from kidney disease, and 35,000 of them die annually from kidney failure. The estimated annual demand for kidney transplants is 5,000. However, only about 100 people on average can obtain kidneys from relatives for transplantation.
The Bangladesh Organ Donation Law of 1999 permits posthumous or brain-death kidney donation outside of living close relatives, but such donation has never been implemented. In accordance with the law passed in 1999, only brothers, sisters, father, mother, maternal and paternal uncles and aunts can donate kidneys. Since 1982, approximately 1400 kidney transplants, 5500 cornea transplants, and 4 liver transplants have occurred in Bangladesh. Cornea transplantation, on the other hand, has reached an acceptable level with a threefold increase in transplantation since 2009.
Organ transplantation is a modern medical and technological treatment that saves the lives of hundreds of thousands of patients with end-stage organ failure who are suitable candidates. In Bangladesh, the first successful kidney transplantation from living-related donors was performed in 1982, and the procedure became routine in 1988. This was followed by cornea from deceased donors in 1984, liver from living-related donors in 2010 and bone marrow from living-related donors in 2014.
The Human Organ Transplantation Act was initially passed by the parliament of Bangladesh in 1999, allowing both brain-death donation and transplants from living-related donors. Before 1999, religious approval (fatwa) was obtained from religious leaders that acknowledged brain death donation and permitted deceased donation for transplants. In January 2018, the current law was revised. Only 1791 kidney, six liver, and 25 bone marrow transplants were performed from living-related donors between 1982 and 2017. In Bangladesh, no transplants of deceased organs have yet begun. Only 5,500 corneas from deceased donors have been transplanted.
Long-standing concerns exist regarding the lack of transplantation of vital organs from deceased donors in Bangladesh and its effect on the rising demand for organs from living donors. However, living-related donors are extremely scarce. Patients with multiple failing organs are frequently forced to purchase organs from the poor. In Bangladesh, it creates an illegal and unethical market for human organs.
Condition of Government Hospitals and Clinics:
However, government hospitals and clinics are always overcrowded because the vast majority of treatment, drugs, and medications are supposed to be provided for free or at minimal cost, whereas privately funded hospitals are expensive and unaffordable for the vast majority of the population. Due to limited resources, organ transplantation and other tertiary-level healthcare services are not a top priority for the Bangladeshi government.
Removal and Transplant and exceptions in regards to Eye and Bone Marrow
According to the initially proposed "Transplantation of Human Organs Act-2017," organ removal and transplant cannot be performed in any hospital without government approval.
Eye and bone marrow transplant donors are not required to be blood relatives. However, public hospitals with specialized transplant units could perform transplants without government authorization.
In accordance with the current law, which was enacted in 1999, a person who violates the law could face between seven and three years of imprisonment or a fine of Tk 3 lakh, or both. The proposed law stipulated a maximum prison sentence of three years and a fine of Tk 10 lakh, or both.
In addition, there would be a four-person hospital certification board led by the director of the health directorate. Without the board's certification, no organ transplants would be permitted in any hospital. Under the proposed law, anyone who provides false information about the relationship between an organ donor and a recipient, or who encourages, provokes, or threatens another person to provide such information, faces up to two years in prison or a fine of Tk 5 lakh, or both.
Kidney, liver, bone, eye, heart, lungs, and tissue are among the transplantable organs.
The parliament has passed the "Transplantation of Human Organs (Amendment) Bill, 2018" in an effort to improve health services in Bangladesh in light of technological and medical advancements.
According to the proposed law, there will be a medical board in each hospital to decide transplantation issues and a National Cadaveric Committee to oversee the transplantation of human organs in Bangladesh. According to the proposed law, any organ transplantable to the human body, including the kidney, liver, bone, eye, heart, lung, and tissue, could be transplanted after their collection from heart-beating or actively supported human bodies for transplantation purposes.
In the early years of organ transplantation, there was no law in Bangladesh prohibiting the sale of organs in underground markets. The Human Organ Transplantation Act (HOT A, 1999) was initially passed by the parliament of Bangladesh and published in the Gazette on April 13, 1999 in an effort to restrict organ trade. This act applied to the removal of organs for transplantation from both deceased and living donors. In addition to the kidney, heart, liver, pancreas, bone, asthimajja, eye, skin, and tissue, it authorized the removal of any other transplantable organs or body parts (section- 2a).
Human Organ Transplantation Act and Religious leaders:
Before 1999, religious leaders in Bangladesh issued a fatwa (religious approval) that recognized both living and brain death criteria and permitted both living and brain-dead donors to donate organs for transplantation.
A close relative may only donate organs to save the lives of other close relatives, per the Human Organ Transplantation Act 1999 Act. Only first and second-degree blood relatives and spouses are included. First-degree blood relatives are the father, mother, adult brother and sister, and adult son and daughter; second-degree blood relatives are the paternal and maternal uncles and aunts. Spouses consist of both husbands and wives. Except for these close relatives, no one was legally permitted to donate organs.
A few provisions of the existing law were revised and approved by the government in January 2018. The 2018 revision of the Act expands the definition of "close relatives" to include third-degree blood relatives in addition to the existing donors. Grandparents, grandchildren, and first cousins comprise third-degree blood relatives.
The new law stipulates that anyone can donate bone marrow and cornea to anyone else, but other organs and body parts may only be donated between close relatives who are on the act's donors list. This act prohibits the sale of organs and the receipt of monetary compensation for organ exchange. It also prohibits organ sales advertisements in their entirety.
Current Scenario for the need of transplants:
Bangladesh has a population of approximately 1.6 million, of which approximately 20 million suffer from kidney diseases and an additional half a million suffer from corneal diseases. Although the need for organ transplants to cure a growing number of patients is growing, the culture of organ donation in the United States is not well-established.
Even though Act No. 05 of 1999 was enacted in response to instances of abuse, it is riddled with flaws that defeat the very purpose for which it was enacted. Section 3 in conjunction with sections 2(ga) and 6(1) of Act No. 05 of 1999 provides a very narrow definition of donor, namely "close relative." This narrow definition of donors exacerbates the already substantial disparity between the demand for and supply of kidneys, resulting in kidney patients dying without transplant.
The large disparity creates a thriving black market for kidneys, which disproportionately affects the poor. According to Global Financial Integrity (GFI) of Washington, many people in Bangladesh, particularly in rural areas, are compelled to sell their organs to settle debts or for brief financial relief. They are poor, uneducated, destitute, and oblivious to the after-sale complications. Several of them develop chronic health problems. A minority are better off.
The brokers minimize the risk of future complications, and sometimes physicians even assure prospective sellers that their kidneys will regrow. Common postoperative complications include infection, persistent pain, fatigue, and impaired function of the remaining kidney.
Close Relative and Exceptional circumstances for Organ Donation Law in Bangladesh
As a result, a provision must be made for exceptional circumstances in which a donor may not be a "close relative," and "exceptional circumstances" must be defined and/or criteria must be established for their determination. The Act No. 05 of 1999 does not establish a central authority to regulate the removal and use of Organs for Transplantation.
The enactment of Act No. 05 of 1999 was necessitated by the need for such a regulatory body to prevent abuse. In the United Kingdom, one such authority is the Human Tissue Authority (HTA) (UK). Due to the inadequacies of Act No. 05 of 1999, kidney patients are compelled to travel abroad with donors (who do not fall within the Act's narrow definition of "near relative") for the purpose of Transplantation in violation of the Act; kidney transplant abroad is very expensive compared to the cost of having it done locally and is therefore out of reach for many.
If section 2(4) is further amended, anarchy will ensue in the organ transplantation sector of our nation. Section 7 of Act No. 01 of 2018 establishes the Cadaveric National Committee, which will oversee all cadaveric kidney transplants in Bangladesh. The Government has already formulated (briefly, the Rules of 2018) in accordance with Act No. 05 of 1999 in order to carry out the purposes of Act No. 05 of 1999.
In light of the global trend of increasing the number of organ donors, the high prevalence of kidney disease in Bangladesh, and the vast disparity between the demand for and supply of kidneys in Bangladesh, the court deemed it necessary to obtain the expert opinions of several individuals prior to deciding the Rule Nisi.
Illegal Organ Donation:
According to various news reports, illegal Organ donation is causing illicit financial flows out of the country, and as a result, people are turning to dialysis as a treatment method, which is economically and medically unsustainable in the long run; patients typically discontinue treatment within three years. In order to prevent the loss of 35,000 to 45,000 lives annually due to completely preventable causes, it is essential that some guidelines are formulated and eventually amendments are made to Act No. 05 of 1999 in order to address the crisis of kidney donation and transplantation.
There is no study in Bangladesh that estimates the prevalence of kidney disease and the need for organ transplants. However, some estimates indicate that at least 20 million people in Bangladesh suffer from kidney disease, and 35,000 of them die annually from kidney failure. The estimated annual demand for kidney transplants is 5,000. However, only about 100 people on average can obtain kidneys from relatives for transplantation.
The Bangladesh Organ Donation Law permits posthumous or brain-death kidney donation outside of living close relatives, but such donation has never been implemented. In accordance with the law passed in 1999, only brothers, sisters, father, mother, maternal and paternal uncles and aunts can donate kidneys.
Since 1982, approximately 1400 kidney transplants, 5500 cornea transplants, and 4 liver transplants have occurred in Bangladesh. Cornea transplantation, on the other hand, has reached an acceptable level with a threefold increase in transplantation since 2009.
Organ Donation Law in Bangladesh and technological treatment
Organ transplantation is a modern medical and technological treatment that saves the lives of hundreds of thousands of patients with end-stage organ failure who are suitable candidates. In Bangladesh, the first successful kidney transplantation from living-related donors was performed in 1982, and the procedure became routine in 1988. This was followed by cornea from deceased donors in 1984, liver from living-related donors in 2010 and bone marrow from living-related donors in 2014.
The Human Organ Transplantation Act was initially passed by the parliament of Bangladesh in 1999, allowing both brain-death donation and transplants from living-related donors. Before 1999, religious approval (fatwa) was obtained from religious leaders that acknowledged brain death donation and permitted deceased donation for transplants.
In January 2018, the current law was revised. Only 1791 kidney, six liver, and 25 bone marrow transplants were performed from living-related donors between 1982 and 2017. In Bangladesh, no transplants of deceased organs have yet begun. Only 5,500 corneas from deceased donors have been transplanted.
Long-standing concerns exist regarding the lack of transplantation of vital organs from deceased donors in Bangladesh and its effect on the rising demand for organs from living donors. However, living-related donors are extremely scarce. Patients with multiple failing organs are frequently forced to purchase organs from the poor. In Bangladesh, it creates an illegal and unethical market for human organs.
Healthcare system in Bangladesh and Organ Donation Law in Bangladesh
The healthcare system in Bangladesh is hierarchically structured from top to bottom. The Ministry of Health and Family Welfare is positioned at the top and provides policy advice to the two directorates of health services and family planning.
After receiving policy recommendations, the Directorate General of Health Services and the Directorate General of Family Planning implement these policies throughout the nation's hospitals and healthcare facilities. The healthcare service delivery system is hierarchical, proceeding from the national level to the district, subdistrict, union, and ward levels.
This system provides primary, secondary, and tertiary levels of promotion, prevention, and treatment for outdoor and indoor patients. In rural areas, sub-district, union, and ward-level hospitals and clinics provide primary healthcare services; district hospitals provide secondary services; and hospitals and institutes in divisional and capital cities provide secondary and primarily tertiary level services. In addition, medical college hospitals and institutes supported by the public provide healthcare services.
According to the initially proposed "Transplantation of Human Organs Act-2017," organ removal and transplant cannot be performed in any hospital without government approval, Additional Cabinet Secretary Ashraf Shameem told reporters after the weekly cabinet meeting. Eye and bone marrow transplant donors are not required to be blood relatives. However, public hospitals with specialized transplant units could perform transplants without government authorization.
Transplantation of Human Organs (Amendment) Bill, 2018
In accordance with the current law, which was enacted in 1999, a person who violates the law could face between seven and three years of imprisonment or a fine of Tk 3 lakh, or both. The proposed law in Organ donation stipulated a maximum prison sentence of three years and a fine of Tk 10 lakh, or both.
In addition, there would be a four-person hospital certification board led by the director of the health directorate. Without the board's certification, no organ transplants would be permitted in any hospital. Under the proposed law, anyone who provides false information about the relationship between an organ donor and a recipient, or who encourages, provokes, or threatens another person to provide such information, faces up to two years in prison or a fine of Tk 5 lakh, or both.
Kidney, liver, bone, eye, heart, lungs, and tissue are among the transplantable organs.
The parliament has passed the "Transplantation of Human Organs (Amendment) Bill, 2018" in an effort to improve health services in Bangladesh in light of technological and medical advancements.
According to the proposed law for Organ donation, there will be a medical board in each hospital to decide transplantation issues and a National Cadaveric Committee to oversee the transplantation of human organs in Bangladesh. According to the proposed law, any organ transplantable to the human body, including the kidney, liver, bone, eye, heart, lung, and tissue, could be transplanted after their collection from heart-beating or actively supported human bodies for transplantation purposes.
Prohibiting the sale of organs in underground markets
In the early years of organ transplantation, there was no law in Bangladesh prohibiting the sale of organs in underground markets. The Human Organ Transplantation Act (HOT A, 1999) was initially passed by the parliament of Bangladesh and published in the Gazette on April 13, 1999 in an effort to restrict organ trade.
This act applied to the removal of organs for transplantation from both deceased and living donors. In addition to the kidney, heart, liver, pancreas, bone, asthimajja, eye, skin, and tissue, it authorized the removal of any other transplantable organs or body parts (section- 2a). Before 1999, religious leaders in Bangladesh issued a fatwa (religious approval) that recognized both living and brain death criteria and permitted both living and brain-dead donors to donate organs for transplantation.
A close relative may only donate organs to save the lives of other close relatives, per the 1999 Act. Only first and second-degree blood relatives and spouses are included. First-degree blood relatives are the father, mother, adult brother and sister, and adult son and daughter; second-degree blood relatives are the paternal and maternal uncles and aunts. Spouses consist of both husbands and wives. Except for these close relatives, no one was legally permitted to donate organs.
A few provisions of the existing law were revised and approved by the government in January 2018. The 2018 revision of the Act expands the definition of "close relatives" to include third-degree blood relatives in addition to the existing donors. Grandparents, grandchildren, and first cousins comprise third-degree blood relatives. The new law stipulates that anyone can donate bone marrow and cornea to anyone else, but other organs and body parts may only be donated between close relatives who are on the act's donors list. This act prohibits the sale of organs and the receipt of monetary compensation for organ exchange. It also prohibits organ sales advertisements in their entirety.
Punishment for illegal dealings in Human tissue in Bangladesh-
Whoever-
(a) makes or receives any payment for the supply of, or for an offer to supply, any Human tissue; or
(b) seeks to find person willing to supply for payment and Human tissue; or
(c) offers to supply any Human tissue for payment; or
(d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any Human tissue; or
(e) takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement referred to in clause (d); or
(f) publishes or distributes or causes to be published or distributed any advertisement-
(i) inviting persons to supply for payment of any Human tissue; or
(ii) offering to supply any Human tissue for payment; or
(iii) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d); or
(g) abets in the preparation or submission of false documents including giving false affidavits to establish that the donor is making the donation of the Human tissues as a near relative or by reason of affection or attachment towards the recipient, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years.
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What is the Sunni Muslim Perspective on Organ Donation?
Many Muslims have historically and currently held the view that organ donation is haram, or forbidden.
This is due to the fact that the human body is regarded as sacred, and the Prophet Muhammad, upon whom be peace, stated that the body remains sacred after death and should not be harmed. He stated that breaking the bones of the deceased is equivalent to breaking the bones of a living person.
Similarly, the Quran states, "Whoever saves a life is as if he saves the lives of all humanity."
Therefore, many Muslims conclude from this verse that organ donation is a blessed act.
In 1995, the Muslim Law (Sharia) Council of the United Kingdom issued a fatwa allowing organ donation. In 2019, Mufti Muhammad Zubair Butt agreed in principle that it was permissible, but he disagreed with the earlier opinion, stating that organs can only be extracted after the heart has stopped beating, whereas the earlier ruling stated that they can be extracted after brainstem death. Most recently, in 2020, Shaykh Dr. Rafaqat Rashid has written further on the subject, reiterating the Islamic legitimacy of using brainstem death as the accepted definition of death for organ retrieval.
In conclusion, Sunni Muslims may adopt one of three positions regarding donation after death. They may decide to:
1.Donate their organs following brainstem death (DBD) or circulatory death (CD) (DCD)
2. Donate their organs, but only after they have died of circulatory failure
3. Refuse to donate organs
What is the definition of 'donor' as per the Transplantation Act in Bangladesh?
The verdict stated, "The already large gap between demand and supply of kidneys is widened by this narrow definition of donors, resulting in kidney patients dying without a transplant," adding, "The large gap disproportionately affects the poor by creating a black market for kidneys where abuses are rampant."
The verdict stated that if the definition of a donor pool (close relative) was expanded without any restrictions, the illegal kidney trade in Bangladesh would increase to an unfathomable degree. Therefore, a wholesale expansion of the definition of donor pool (close relative) cannot be tolerated.
To determine and verify the authenticity of emotional kidney donation, the court ruled that an investigation should be conducted in accordance with the following guidelines.
According to the ruling, the Authentication Board in Bangladesh, similar to the Authorization Committee in India, could decide on the petitioner's exceptional circumstances.
The court ruled that the board must ensure that any adult person related to the donor by blood or marriage donates an organ or tissue if a close relative is unavailable.
What are the responsibilities of authentication board in terms of donor law in Bangladesh?
The board must determine that no commercial transaction would take place between the recipient and the donor, and that no payment has been made or promised to be made to the donor or any other person.
The board must also prepare an explanation of the relationship between donors and recipients, as well as the circumstances that led to the offer being made.
To investigate why the donor wishes to donate, the board must examine documentary evidence of the link as well as old photographs of the donor and the recipient together.
The board must ensure that no middleman or tout was involved.
The board also requires evaluating the donor's and recipient's financial status by asking them to provide evidence in support of their vocations and income for the previous three fiscal years, as well as any gross disparity between the two parties' statuses to prevent commercial dealing.
The board also requires that the donor not be a drug addict.
The court ordered the Authentication Board to assess the donor's mental health and inform him of any potential negative consequences of kidney donation.
The court stated that if the Authentication Board rigorously ascertained the authenticity of an emotional donation by a known or related donor (but not unknown or unrelated), there would be a check and balance and the possibility of illegal kidney trade would be greatly reduced.
What is the most recent high court ruling on Organ Donation law in Bangladesh?
In December 2019, the High Court of Bangladesh issued an order amending the 2018 law to allow known persons other than relatives to donate kidneys. A nine-point policy was issued. Physical and mental examinations, as well as a "authenticity of emotional donation of a known or related donor," old photographs, a record of finances for the previous three years to look for gross anomalies in income, and other procedures were required.
In light of the high court's plea for such relaxation of Bangladesh's rule, and its contrast with laws in many other countries, it is worthwhile to investigate the possible and known arguments for restricting the act of organ donation.
Arguments for Donation Restrictions:
Restrictions on organ donation are typically justified by a number of arguments.
Corruption and Commodification: If organs can be sold for a profit, human trafficking may increase. Organ trafficking is a real issue in places like Bangladesh .It has been demonstrated that even when organs are exchanged between known people, money is likely to be exchanged. Any restrictions on behind-the-scenes dealings are nearly impossible to impose.
Exploitation: An open market for organs would result in the exploitation of weaker parties for organ harvesting. Unevenness in relationships does not have to be monetary.
Coercion: Similar inequalities in relationships can lead to coercion, even within a family.
Crowding Out:
If organs are bought and sold, wealthy clients will simply participate in the market rather than have an incentive to donate altruistically. Indeed, it has been demonstrated that loosening the restrictions on LURDS (organs exchanged for money) does not increase the number of transplants, but rather shifts the curve from altruistic donations to financially acquired organs.
The expansion of kinship in 2018 was expected to reduce the black market for organs.
The recent high court decision wishes to extend this to any known person with a proper mechanism in place, in order to avoid some of the problems mentioned above. While it is possible to distinguish a completely altruistic donation in extremely emotionally charged cases, a permission-based donation may be difficult to implement and manage when the number of donations is large.
Given that Bangladesh already has a black market for organs, ensuring the genuineness of many of the criteria may be difficult, even if the two are known to one another and come from financially compatible groups. Furthermore, limiting the right to donate for emotional reasons to those who are financially secure may appear discriminatory.
The poor may have feelings for related fellows to whom they would like to donate organs. A law requiring equal treatment for equal cases increases the possibility of abuse, though it is certainly possible to use the criteria to coerce someone from a wealthy family. The ability to resist is not always linked to one's financial situation, especially when family and peer pressures are involved.
What is the rule on unclaimed bodies in Bangladesh?
The laws of property, trust, and wills do not apply to the dead body because it is not a legal property of the former legal person. The sentiment of society toward the dead is valuable. When possible, a good law balances various interests and also considers social sentiments in policymaking while providing forms of freedom. This takes into account both individual rights and societal cohesive factors.
The law considers the fabric of the specific society and understands the implications for the various adhesive factors. While Lord Devlin and Hart disagree on the extent to which moral sentiments should be considered in a law, deterioration of values, eventually leading to corruption, which is the consequential corruption of allowing a certain procedure, is important if these consequences can be properly identified. At times, the law refuses to enter areas where the end result is unknown, causing society to slide down a cliff (R v Conway).
Allowing the acquisition of organs from unclaimed bodies in Bangladesh, where a large number of people are not covered by any social welfare scheme and where homeless and drifting people abound, may be analogous to taxing the dead for a life lived with little social support, placing an undue burden on the already neglected part and possibly creating further social alienation or corruption of values regarding social cohesion.
While obtaining organs from unclaimed bodies may reduce pressure on the black market, the act may also reinforce the notion that certain people are disposable. In the author's opinion, while harvesting organs from unclaimed bodies may increase the number of transplants, it may be a better choice in Bangladesh's socioeconomic context to first try to increase the number of consenting donors.
How to Establish a Pharmaceutical Company in Bangladesh:
Due to the fact that 98% of the country's total medicine demand is satisfied by local institutions, the pharmaceutical business in Bangladesh has tremendous growth potential. In addition to serving domestic demand, the enterprises export pharmaceuticals to a number of international markets. During the fiscal year 2019-20, Bangladesh earned 136 million from the export of pharmaceuticals. Moreover, Bangladesh ranks 71st globally out of 134 nations in terms of pharmaceutical exports.
Bangladesh produces homeopathic, unani, and ayurveda medicines in addition to allopathic medications. Presently, there are over 257 pharmaceutical businesses in Bangladesh that produce approximately 80% of generic medications. Presently, indigenous businesses such as Square, Beximco, Reneta, and Opsonin dominate the Bangladeshi pharmaceutical sector.
Industry Analysis of Pharmaceutical Companies in Bangladesh
The pharmaceutical industry in Bangladesh was founded in the 1950s by multinational corporations and local businesses. The British Patents and Designs Act of 1911 exempted Bangladesh, as a least developed nation, from patents in the pharmaceutical business upon its independence in 1971. As a result, the nation's output of generic drugs began to expand. However, the pharmaceutical sector began to expand in the 1980s. In 1981, Bangladesh had 166 licensed pharmaceutical firms.
However, eight international corporations such as Glaxo, Pfizer, and Hoechst dominated the country's pharmaceutical production and supplied 75% of the country's pharmaceuticals. At that time, 25 medium-sized local pharmaceutical companies produced 15% of the nation's total pharmaceuticals, while 133 companies produced the remaining 10%. All of these enterprises used to produce pharmaceuticals locally using imported raw materials valued at BDT 60 billion annually. Despite having 16 domestic pharmaceutical businesses, 30 billion Bangladeshi Taka worth of pharmaceuticals were imported annually.
Bangladesh's pharmaceutical value chain is mostly separated into two sections. The first is Active Pharmaceutical Ingredients, or API, and the second is Formulation Complete. API essentially refers to medications that include unique active components to treat certain ailments. On the other hand, Finished Formulation refers to the drug created by combining several substances with Active Ingredients.
In March of 1982, the government established a committee of experts to design a drug strategy. The group develops policies for both the formulations and API industries. However, the previous government only permitted the issuance of the Drugs (Control) Ordinance for the formulations sector, and in June, two other new regulations were established. The first was to restrict the manufacture, import, and sale of hazardous and unnecessary pharmaceuticals, and the second was to ban the products of multinational corporations that did not have their own manufacturing facilities in the country. According to Sudip Chaudhuri's research, EVOLUTION OF THE PHARMACEUTICAL INDUSTRY IN BANGLADESH, Bangladesh did not remove any of the regulations despite pressure from the U.S. administration at the time.
Market cap-shares of Pharmaceutical Company in Bangladesh
In 2018, the local pharmaceutical market was worth 205.12 billion BDT. The market grew at a CAGR of 16.51 percent between 2014 and 2018. Five businesses control 46.66 percent of the market, according to Square Pharmaceuticals officials using IQVIA data. Although Square Pharma's annual sales in 2018 climbed to BDT 1.06 billion from BDT 33.70 billion in 2017, the company's market share decreased by 0.52% points, from 17.47%.
Incepta's annual sales are BDT 22.73 billion, Beximco's are BDT 16.94 billion, Renata's are BDT 10.66 billion, Health Care's are BDT 10.61 billion, Opsonin's are BDT 10.42 billion, ACI's are BDT 8.99 billion, Eskayef's are BDT 8.96 billion, Aristopharma's are BDT 8.42 billion, and ACME's are BDT 7.21 billion. Square has dominated the market for the past 32 years. The reasons are the doctor's confidence and the customers' and people's trust due to the company's commitment to ethics, transparency, and honesty. In 2018, six of the top ten firms, including Square, Beximco, Opsonin, ACI, Aristopharma, and ACME, lost market share due to increased competition.
The research also revealed that the sales of eight companies climbed in 2018, while the revenues of only two companies, namely Opsonin and ACME, declined.
The top ten organizations are very likely to adopt current technology and retain manufacturing and marketing excellence. Consequently, over 70% of the market share is held by these companies. The nation's leading pharmaceutical corporations are creating the infrastructures and procedures necessary to meet global quality standards.
According to IQVIA data from 2018, the antiulcerants class (acidity) had the largest sales (BDT 30,134.8 million) among the top 20 therapeutic drugs, followed by the cephalosporin class (antibiotic) with sales of BDT 16,876.1 million. The sales rise of antiulcerants was 6.55 percent last year.
Square Pharmaceuticals has sold the most medications in this class. The company manufactures and distributes Seclo medications. Healthcare and Incepta are the second and third best-selling subjects in this category, respectively. Companies sell assidy medications under the brand names Sergel and Pantonix. Human insulin accounted for BDT 7,021.9 million in annual sales, calcium for BDT 7,009.5 million, antirheumatic medications (non- steroid painkiller) for BDT 6,594.1 million, antiepileptic (nervous system drug) for BDT 6508.7 million, and non- narcotic analgesics (painkiller) for BDT 6434.7 million.
LICENSE AND REGISTRATION PROCESS for a Pharmaceutical Company in Bangladesh
In Bangladesh, the Pharmaceutical Company business can be conducted by founding a corporation:
Pharmaceutical Company Formation in Bangladesh:
A company lawfully registered in Bangladesh may participate in any business activity permitted under its Object Clause, as stated in its Articles of Association. A firm in Bangladesh may be either public or private. For the formation of a public company, a minimum of seven shareholders are necessary.
Alternatively, a minimum of two shareholders is required to incorporate a private corporation. A private corporation cannot invite the public to subscribe for its shares, but a public firm can offer its shares to the general public. In actuality, private companies are the most preferred business structure for both foreign and domestic entrepreneurs. There are no restrictions on foreign equity involvement for foreign direct investment, hence 100 percent foreign equity is permitted.
The following actions must be taken to establish a company:
The prospective company must get a Name Clearance from the Registrar of Joint Stock and Companies.
Drafting and signing the following documents: • Memorandum and Articles of Association of the company; • Form I: Declaration On Registration Of Company; • Form VI: Notice Of Situation Of Registered Office; • Form IX: Consent of director to act; • Form X: List of Individuals Consenting to be Directors; • Form XII: Particulars of the directors, manager, and managing agents.
Establishing a temporary bank account for the Proposed Company with any Bangladeshi bank on the list
a) A copy of the Valid Name Clearance for the proposed company; b) an executed copy of the company's Memorandum and Articles of Association. c) Executed copy of Form I: Declaration On Registration Of Company; d) Executed copy of Form VI: Notice Of Situation Of Registered Office; e) Executed copy of Form IX: Consent of director to act; f) Executed copy of Form X: List of Individuals Consenting to Be Directors; g) Executed copy of Form XII: Particulars of the directors, manager, and managing agents; h) Copies of National ID of shareholders and directors (for Bangladeshi Nationals); I Copies of TIN Certificate of shareholders and directors (for Bangladeshi Nationals); j) Copies of passport of shareholders and directors (for Foreign Nationals); k) Passport size photographs of shareholders and directors; l) Bank Encashment Certificate for each foreign shareholder; m) Receipt of payment of the government fees.
In addition to the above-mentioned formats, a firm with 100% foreign ownership may also register as a Branch Office to commence Pharmaceutical Company business. However, a Branch office can only serve the job envisioned by the parent firm if Bangladesh Investment Development Authority has granted prior authorisation. Depending on the expansion/scope of the business, further licenses or approvals may be necessary following the formation of the specific firm.
Additional Permissions for Pharmaceutical Company in Bangladesh
TIN Certificate for a Pharmaceutical Company in Bangladesh:
The Government of Bangladesh issues a TIN Certificate to individuals and businesses in order to monitor tax payments. The National Board of Revenue (NBR) is the only organization authorized to issue TIN Certificates. To receive the TIN Certificate, one must submit an online application to the NBR.
VAT Certificate for a Pharmaceutical Company in Bangladesh:
Every business must have a Business Identification Number in order to function (BIN). A BIN can be obtained through the National Board of Revenue's VAT registration process. Every business organization must get a certificate of VAT registration. To obtain the VAT Certificate, the NBR must receive an online application along with the required supporting documentation.
Registration of Industrial Investment Project: Local or foreign industrial businesses in Bangladesh must register with the Bangladesh Investment Development Authority (BIDA). To register an Industrial Investment Project with the BIDA, an application and the required documentation must be submitted.
Factory Layout Approval:
Prior to the use, modification, or enlargement of any dwelling, building, or premises as a factory, the Department of Inspection for Factories and Establishments (DIFE) must grant written approval. The DIFE must receive an application accompanied by the required documentation in order to grant approval for the proposed layout.
License of Factory: Each owner or occupier must submit an application for registration and license of factory to the Department of Inspection for Factories and Establishments (DIFE) within thirty (30) days prior to the start of work for factories.
After establishing the related business, the entrepreneur must become a member of a local Chamber of Commerce and Industry or pertinent Trade Association. The membership application is accessible at the office of the respective Chamber of Commerce or Trade Association.
Certificate of Import Registration and Certificate of Export Registration for Pharmaceutical Company in Bangladesh:
An importer who possesses an Import Registration Certificate (IRC) and an exporter who possesses an Export Registration Certificate (ERC) are able to import and export any permissible goods without any value or quantity restrictions or approval from any authority. The Office of the Chief Controller of Imports and Exports (CCI&E) provides applicants with Import Registration Certificates and Export Registration Certificates. To obtain the IRC or ERC, an online application and supporting documentation must be submitted to CCI&E.
Environmental Clearance for Pharmaceutical companies in Bangladesh
In Bangladesh, the Environment Clearance Certificate (ECC) is one of the essential permits required to launch an industrial unit or project. To get this Certificate, the owner of the industrial unit or project must submit an application to the Department of Environment along with the required documentation.
Fire License for Pharmaceutical companies in Bangladesh
Application for Trademark Registration for a Pharmaceutical Company in Bangladesh:
After the registration of the entity, it may apply to the Department of Patents, Designs and Trademarks (DPDT), which is administered by the Ministry of Industries, for the registration of its trademarks and/or any other Intellectual Property. The Trademark Registry Wing of the DPDT must receive the required documentation for the registration of a trademark from a candidate.
In addition to the Membership Application Form, the following materials must be submitted:
Membership Application on Letterhead Pad.
Constitution and Articles of Incorporation
Incorporation Certificate.
Trade License Validity of the Company
BOI Registration Certificate
Certificate of Taxation for the Company
Company's Certificate of VAT Registration Three (3) copies of the Representative's latest passport-sized photograph and two (2) business cards.
BSTI Certification of Marks (CM) License for a Pharmaceutical Company in Bangladesh:
To use the BSTI Standard Mark, a Certification of Marks (CM) License is required. The following are the steps:
Step 1: Submit a completed application form and the required documentation to the BSTI in order to receive a CM license.
Step 2: The BSTI will inspect the application and all supporting documents.
If the inspection report is deemed satisfactory in Step 3, then random samples are gathered and signed and sealed by the BSTI Officer and the producer.
Step four: The obtained sample is analyzed in the BSTI Laboratory or any other lab recognized by BSTI in accordance with the applicable Bangladesh Standard (BDS)
Step 5: If the results of the test parameters are deemed to be in accordance with the applicable BDS, a license is issued for that article.
Step 6: Typically, a license is granted for a term of three years, which is extended for a subsequent period of three years if the samples are deemed acceptable following the same approach outlined in steps (2) and (5).
A license is required to pay fees to the BSTI, known as the CM fee.
Step 8: A license granted for any object may be cancelled, withdrawn, or revoked at any time if it is determined that the license has violated any of the requirements outlined in the license and the BSTI Ordinance.
Legal Issues:
Foreign Investment Law in regards to Pharmaceutical companies in Bangladesh:
The liberalized Industrial Policy and export-oriented, private sector-led economic strategy of Bangladesh offer substantial investment prospects to foreign businesses and individuals considering investing in Bangladesh. Except for a few regulated industries, Bangladesh welcomes private investment in all areas. The Pharmaceutical Company industry is completely open to foreign investment.
The government's objective is to facilitate the increase of domestic and international private investment by fostering an enabling environment. The policy framework for foreign investment in Bangladesh is based on the Foreign Private Investment (Promotion & Protection) Act of 1980, which provides legal protection against nationalization and expropriation for foreign investment in Bangladesh. This also provides a non-discriminatory handling of international and local investments, as well as the repatriation of capital gains and income.
The Foreign Exchange Regulations Act of 1947, the Bangladesh Export Processing Zones Authority Act of 1980, the Bangladesh Private Export Processing Zone Act of 1996, the Bangladesh Economic Zone Act of 2010 and the Bangladesh Investment Development Authority Act of 2016 also address foreign investment.
Employment Law in regards to Pharmaceutical Company in Bangladesh:
The Labour Act of 2006 primarily governs employment law in Bangladesh. In addition to this Statute, the Labour Rules 2015, the National Labour Policy 2012, the Bangladesh Labour Welfare Foundation Act 2006, the Bangladesh Labour Welfare Foundation Rules 2010, the National Occupational Health and Safety Policy 2013, the Domestic Workers Protection and Welfare Policy 2015, and the National Child Labour Elimination Policy 2010 all contain rules and regulations pertaining to this issue.
The Labour Act of 2006 addresses employment of labor, employer-employee relations, payment of wages and compensation for injuries to workers, leaves, benefits, formation of trade unions, resolution of industrial disputes, welfare, health, safety, and working conditions in the establishment, amongst other matters. Additionally, maternity benefits are provided to female employees. Note that if the company is established within an EPZ, the Bangladesh EPZ Labour Act 2019 will apply.
Contract Law: The center of the economic world is contractual agreement. It specifies the obligations and responsibilities of the parties on the subject of the contract. A contract binds both parties to its agreed-upon and stipulated conditions, such as the party's liability in the event of a breach of contract and the extent to which it would reimburse the other party's damages. It is advisable to take the utmost care while drafting the contract's terms and conditions so that they accurately reflect the parties' intentions. The Contract Act of 1872 governs all contracts in Bangladesh.
A force majeure event is an extraordinary occurrence or scenario beyond the parties' control, such as an act of God, war, or natural disaster. Generally, a successful use of the force majeure clause releases the parties from their respective contractual responsibilities and/or liability.
A force majeure in Pharmaceutical Company clause does not totally excuse a faction's failure to comply, but merely suspends it for a period of time. Section 56 of the Contract Act of 1872 of Bangladesh outlines the notion of frustration. According to this doctrine, a contract is null and void if its performance becomes impossible owing to the occurrence of an event or if it becomes unlawful after it has been entered into.
Compliances of the business entities - The entities must comply with the annual filing requirements, such as updating trade license at the respective city corporation, renewal of chamber membership, renewal of IRC & ERC, filing taxes, updating the annual filings at the RJSC, reporting to Bangladesh Bank, NBR, etc.
Property Law: In order to finalize the registration of the lease or purchase of the land, property laws must also be applied. The Land Reform Act of 2014, the East Bengal Tenancy Rules of 1954, the Survey Act of 1875, the Non-Agricultural Tenancy Act of 1949, the Registration Act of 1908, and the Transfer of Property Act of 1882 are the major statutes in these sectors.
Introduction to the services of Tahmidur Rahman Remura Wahid in regards to Pharmaceutical Company in Bangladesh:
Tahmidur Rahman Remura Wahid TRW Associates (TAHMIDUR RAHMAN REMURA) is a full-service corporate law practice that attempts to provide customers with a comprehensive spectrum of legal services as opposed to specializing on a single area of law. It is one of the largest and most reputable law companies in Bangladesh, providing domestic and international customers with legal counsel that fulfills their needs and expectations. Tahmidur Rahman Remura Wahid offers all services associated with Company Incorporation, Sole Proprietorship, Partnership, and Foreign Company Registration, among others.
The Tahmidur Rahman Remura Wahid Law firm has legal professionals who can guarantee a smooth legal process and assist in obtaining Certificates or Licenses required for Company Incorporation, such as VAT Certificate, IRC/ERC, Name Clearance, Factory/Fire/Environmental License, TIN, Trade License, and other certificates.
In order to establish a Pharmaceutical Company in Bangladesh, Tahmidur Rahman Remura Wahid can give the following services:
Tahmidur Rahman Remura Wahid offers a great and experienced team that can set up a Pharmaceutical Company business efficiently and without difficulty. The legal counsel of Tahmidur Rahman Remura Wahid is able to assist clients with any form of business incorporation through consultations and discussions.
In order to incorporate any form of business, a number of deeds, contracts, and other documents must be created. The legal experts at Tahmidur Rahman Remura Wahid can assist clients in formulating and writing these documents.
Before establishing a business, it is necessary to find an appropriate piece of land. Tahmidur Rahman Remura Wahid can provide a service to the client by locating an ideal place for the client's business establishment. In addition, Tahmidur Rahman Remura Wahid can assist with the drafting of lease agreements, the inspection of land by the appropriate land registry office, the preparation for the acquisition of land, including registration, and so on.
Tahmidur Rahman Remura Wahid can also assist with the payment of government fees to the appropriate body, such as BIDA or RJSC, and interact with them to get the necessary documentation for business incorporation. Legal professionals, such as TAHMIDUR RAHMAN REMURA, have excellent working relationships with government authorities, making it easy to obtain any certificate or license.
Trademark/Copyright/Patent registration is sometimes required to incorporate a Pharmaceutical Company in order to obtain protection against infringement, to add value to the organization, and to increase legal protection. Tahmidur Rahman Remura Wahid aids its customers in registering for
Trademark/Copyright/Patent from the Department of Patents, Designs, and Trademarks (DPDT), providing the legal protection of the company.
Tahmidur Rahman Remura Wahid also offers services for obtaining or renewing any form of license; for operating a Pharmaceutical Company business in Bangladesh, it is necessary to obtain multiple licenses. The legal experts at Tahmidur Rahman Remura Wahid can aid with acquiring these licenses and, if necessary, renewing them on time.
Tahmidur Rahman Remura Wahid provides clients with labor-related services, such as creating employment agreements, resolving labor-related issues, and rendering legal opinions on labour legislation.
Tahmidur Rahman Remura Wahid is able to provide counsel and assistance to ensure that a company's routine operations function smoothly.
Impact of COVID-19 on business
While the entire world is urging people to remain at home for safety reasons, this has had a devastating effect on the global economy. In order to safeguard its citizens from the COVID-19 pandemic, the Bangladeshi government has resorted to a lockdown mechanism, as have other governments around the world. However, this has had a negative impact on the country's economic sectors, particularly export-oriented companies.
Economic Package COVID-19 for the sector:
The Bangladeshi government has announced stimulus packages totaling Tk 95,619 crore (3.3% of the country's GDP) to combat the potential negative effects of the COVID-19 outbreak on the national economy. The government has offered export-oriented firms a Tk 5,000 billion "stimulus package" to pay workers' wages. The fund may only be utilized to compensate workers and employees in export-oriented industries with salary and benefits. In addition, the government would give significant enterprises and service sectors affected by COVID-19 with operating capital of Tk 30,000 billion at an interest rate of 4.5 percent. Although the loan's interest rate will be 9 percent, the government will subsidize the remaining interest paid by each bank.
Taxation for Pharmaceutical Company in Bangladesh:
The current general tax rate in Bangladesh is 32.5 percent, as stipulated by its legislation. Locally created limited liability companies are required to submit a variety of reports to the National Board of Revenue (NBR), including: opening a Tax Identification Number (TIN), submitting an annual return, and submitting an annual return for the previous year. Monthly Tax Deduction Statement, Semi-Annual Withholding Tax Statement, Annual Statement Relating to Employee Tax Return Filing, Annual Statement Relating to Salary Paid by the Company to Employees. Quarterly Advance tax deposit, Annual tax return submission, representing the company at appeal/hearing sessions, Monthly VAT return, etc. Tahmidur Rahman Remura Wahid is able to provide counsel and assistance to ensure that all regulatory compliances are met, so allowing the business to operate without difficulty.
The article's information may be influenced by market data system outages or faults, both internal and external, as well as by the rapid occurrence of market events. The report may contain forward-looking statements, projections, estimates, and forecasts that are based on reasonable assumptions and information currently available to us and are subject to certain risks and uncertainties.
Numerous unknown or uncontrollable risks and uncertainties may cause actual results to differ materially from the results, performance, or expectations expressed or implied by such forward-looking statements. All investors should be warned that the forward-looking statements contained in this report are not assurances of future performance. Prior to making any investment, investors should exercise sound discretion and conduct thorough research.
All opinions and estimations in this report are subject to change without notice and without legal liability due to unforeseen circumstances. Tahmidur Rahman Remura Wahid TRW disclaims any duty to update or alter any such forward-looking statements to reflect new information, events, or circumstances after the article's publication to reflect the occurrence of unanticipated events and their outcomes.
Are you intending to set up a Pharmaceutical Company in Bangladesh?
The legal team of Tahmidur Rahman, The Law Firm in Bangladesh: TRW, The Law Firm in Bangladesh are highly experienced in providing all kinds of services related to acquiring a Pharmaceutical Company in Bangladesh. For queries or legal assistance, please reach us at:
What are the required documents for Issuance of Registration for Foreign Medicine in Bangladesh?
Required Documents
Remarks
Application by the local nominated representative in Bangladesh
Original
Completed Form DA-1/88
Original
Evaluation fee of Recipe through Treasury Challan
Through Bangladesh Bank/Sonali Bank
Organization’s Profile
Product Profile
Certificate of Pharmaceuticals Products (CPP)/Free sale certificate (FSC)6 Signed by the producing country’s health authority
A copy duly attested by the Bangladesh Embassy of that concern county
In case of medicine for human being:
FSC/CPP of Country of Origin (if Australia, France, Germany, Switzerland, Japan, UK, USA )
In case of veterinary Medicine Registration :
CPP of country of origin (Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, The Netherlands, Norway, Singapore, Sweden, Switzerland, UK, USA, Russia, Poland, Spain and South Korea)
FSC/CPP from one of the 24 countries (if the country is none of the above mentioned then Country of Origin)
Packet sample in English/Bengali and Brochure
What are the Process Steps for Registration of Foreign Medicine in Bangladesh?
Process Steps for Registration of Foreign Medicine
Step 1
Collects information form the Drug Administration Office
Step 2
Deposits by Treasury Challan and collects the Money Receipt from the Bank
Step 3
Submits the filled- in Application From along with supporting documents, Treasury Challan/Money Receipt
Step 4
Drug Control Committee (DCC) evaluates the Application and Recipe
Step 5
DCC decides whether to provide with the Registration for Foreign Medicine
Step 6
Issues an approval letter if the decision is positive
Step 7
Applicant deposits and submits the Registration Fee, Analysis Fee, CPP/FSC and Packet of the Product (according to the issued letter)
Step 8
Approval of Registration
What are the CTD guidelines and Risk Management Plan provided by DG health in Bangladesh?
According to the CTD guidelines, applications for proposed indications that occur in children must routinely analyze the safety and efficacy in the pediatric population.
If this medication has a pediatric development program, please mention it and, if so, refer to the appropriate sections of the dossier.
Plan for Managing Risk
When a safety concern with the reference product necessitates additional risk minimization actions, the applicant should include a risk management plan for biological products as well as for generic medications.
Include a risk management plan in applications involving: A significant new registration (for instance, a new dosage form, new route of administration, or a significant change in indications), unless the DGDA has agreed that it is not necessary.
A material modification to a registration (such as a new method of producing a biotechnologically derived product).
Certain products, like fixed-dose combination applications, might call for a risk management strategy.
What are the related laws when it comes to Pharmaceuticals company in Bangladesh?
The government of the People's Republic of Bangladesh's Ministry of Health & Family Welfare is home to the Directorate General of Drug Administration (DGDA), which serves as the nation's drug regulatory body.
The DGDA is responsible for overseeing and enforcing all drug regulations currently in effect in the nation. It also regulates all activities related to import, procurement of raw materials and packing materials, production and import of finished drugs, export, sales, pricing, etc. of all types of medications, including those from the Ayurvedic, Unani, Herbal, and Homoeopathic systems.
The DGDA currently oversees 47 district offices across the nation. According to drug laws, all DGDA officers perform the duties of "Drug Inspectors" and aid the licensing authority in carrying out his duties effectively. In addition, a number of Committees, including the Drug Control Committee (DCC), the Standing Committee for Imports of Raw Materials and Finished Drugs, the Pricing Committee, and other pertinent Committees, comprised of experts from various fields, are available to advise the Licensing Authority and recommend him on matters relating to drugs and medicines. Field Activities MonitorRegistration Monitor
