The pharmaceutical industry in Bangladesh has emerged as one of the most successful industries in the country in the last two decades. This sector now meets about 98 percent of the domestic demand and has also established a strong position in the international market. However, in recent times, various conditions of the trade agreement with the United States have become a cause for concern for this developing industry in the country. In particular, the strict conditions imposed on Intellectual Property Rights are seen as a threat to the industry. Article 2.6 of the US agreement on intellectual property law states, 'Bangladesh shall provide a robust standard of protection for intellectual property.' Bangladesh shall provide effective systems for civil, criminal and border enforcement of intellectual property rights and shall ensure that such systems combat and deter the infringement or misappropriation of intellectual property…' The message of this clause is that Bangladesh must enforce intellectual property rights (IP) laws more strictly. In particular, emphasis has been placed on the strict implementation of patent laws. Now the question naturally arises - who benefits and who loses in the implementation of this policy?
About 90 percent of the raw materials used in the country come from abroad. A large part of this is unpatented. Who will decide which of this huge quantity of raw materials is under patent, which is not, or which has been infringed? It is worth mentioning that there are more than 250 pharmaceutical companies in Bangladesh, most of which are small and medium-sized. If a strict patent policy is implemented, it may become difficult for them to survive. This may create a risk of the market being concentrated in the hands of a few large companies and multinationals. This may ultimately put great pressure on the price, availability and public health of medicines. The main debate here is not only legal, but also policy-based. On the one hand, there are global trade agreements and intellectual property protection, and on the other hand, there is easy access to medical services for the common man. Different countries around the world have tried to strike a balance between the two. Countries like Brazil, Egypt or Indonesia are managing patent policies in line with national interests.
It is true that Bangladesh, as a Least Developed Country (LDC), enjoys some concessions under the World Trade Organization's TRIPS Agreement, which allows domestic pharmaceutical companies to produce patent-free generic drugs. This has made it possible to reach the public with quality medicines at a lower cost. But if patent protection is tightened in the US trade agreement, this benefit may be reduced. As a result, there is a risk that the production costs of domestic pharmaceutical companies will increase. The cost of producing new drugs will increase due to patent fees, licensing and technological dependence, which will ultimately be passed on to consumers. If the price of drugs for the common man increases, it will have a direct negative impact on public health.
It is worth noting that since Bangladesh is still a least developed country, it does not have to pay patent fees for the production of generic drugs. As a result of this facility, the country's pharmaceutical industry has developed rapidly. Generic drugs are basically drugs whose patent has expired or on which the patent is no longer applicable. Structurally, they are equally effective as branded drugs. Building on this facility, Bangladesh is currently producing about 97 percent of its medicines domestically and exporting them to more than 100 countries.
This industrial structure is built on the 'high volume, low margin' model. In addition, the opportunities for multinational pharmaceutical companies to capture the market may also increase. If strict intellectual property laws are implemented, domestic companies will lag behind in the competition and large foreign companies will be able to dominate the market. This will threaten the self-reliance of the country's pharmaceutical industry. Another important issue is technological dependence. Bangladesh's pharmaceutical industry is largely dependent on its own capabilities. But according to the terms of the agreement, increasing dependence on foreign companies for advanced technology and raw materials will undermine the independence of the industry in the long run.
So the question before Bangladesh is no longer just a trade agreement. It is a question of industrial policy, public health and economic sovereignty. If the terms of the agreement are implemented, there could be major changes in the structure, pricing policy and market system of the country's pharmaceutical industry. Now there is a need to deeply review the issue not only from an administrative perspective, but also from an economic and public interest perspective.
The scary information is that through the agreement, the United States is seeking the rights to all our customs digital information, the 'digital enforcement right' of IP law. That is, they will sit in the hands of all our port and customs data and will be able to follow the labels of the raw materials imported by the manufacturers. That means that access to Bangladesh's customs database and digital information system is being sought through a foreign agreement. This may create a risk that the ability to analyze the data of each imported raw material will be transferred to outside parties. As a result, an uncomfortable picture emerges - technology is in the hands of others, decisions are in the hands of other countries, and in practical application, Bangladeshi institutions are not regulators but implementers.
Therefore, it is important to look at a sensitive and hotly debated issue of this magnitude from a political-economic lens. It is also necessary to look at the histories of patent-related legal battles in each country. Because determining the patentability of raw materials is an internationally troublesome issue. Thousands of cases are pending for years. As such, it is also a judicial or judicial issue. For example, after the death of countless patients in Africa due to the lack of AIDS or TB drugs, a movement developed across Africa against the strict application of patent laws in the production of medicines.
It is important to remember that intellectual property law is not just an administrative or customs issue, it is deeply intertwined with political and economic questions. The patent policy dispute between the 'Global North' and the 'Global South' around the world has a long history. It is directly related to a country's industrial policy, health policy and economic self-reliance. According to experts, if Bangladesh is forced to pay patent fees or LDC benefits are limited, the cost of drug production could increase significantly.
Research has shown that the price of insulin may increase by up to 11 percent. In addition, there is a risk of price increase in medicines for cancer, kidney and hepatitis C. Not only that, the situation may be more complicated due to the weakness of the current market control system in Bangladesh. In some cases, the fear of prices increasing several times cannot be ruled out. Entrepreneurs in the pharmaceutical industry believe that in this case, it is possible to reduce the risk to a great extent through careful policymaking. The government must review the terms of trade agreements by prioritizing national interests. In particular, the issue of ensuring public health and availability of medicines should be given utmost importance. In this regard, first of all, Bangladesh, as a least developed country (LDC) under the World Trade Organization (WTO) TRIPS Agreement, enjoys the benefit of drug patent exemptions until 2033. Maximum utilization of this benefit must be ensured and no condition that reduces this exemption in any way in the US agreement negotiations cannot be accepted. If necessary, the issue of maintaining 'TRIPS flexibilities' must be clearly included.
Second, increasing investment in research and development (R&D) is essential to enhance the capacity of the local pharmaceutical industry. Government incentives, tax breaks, and technical assistance should be provided to encourage domestic companies to produce innovative drugs and biosimilars. This will make it easier to survive in international competition.
Third, improving quality control and regulatory capacity is essential to increase access to the US market. Investing in infrastructure and skills development to meet US FDA or other international standards will increase export potential and leverage the positive aspects of the trade agreement.
Fourth, the government needs to play an active role in ensuring the price and availability of medicines. If the price of medicines increases due to strict patent policies, it will have a negative impact on the common man. Therefore, we must be prepared to use compulsory licensing in cases where necessary.
Fifth, it is important to ensure transparency and stakeholder participation in trade negotiations. Creating a unified position with the views of industry owners, experts, and civil society will make it easier to protect national interests. Finally, it is necessary to increase coordination with like-minded countries by forming regional and international trade alliances.
This will make it possible to participate in the discussions with a strong position. It is possible to protect the pharmaceutical industry of Bangladesh from potential risks and take it to a sustainable position only by adopting a coordinated and far-sighted strategy. In fact, implementing this US trade agreement is a challenge for Bangladesh. However, if proper preparation and strategic decisions are taken, this challenge is not difficult to overcome. Otherwise, this important industrial sector of the country may face disaster. Therefore, now is the time to adopt far-sighted policies and protect this important pharmaceutical industry.
Author: Columnist and entrepreneur
