Local production of Covid-19 vaccines

As intellectual property rights, including patents, reward and encourage innovators for more research and development (R&D) leading to inventions, a least developed country (LDC) like Bangladesh that will graduate in 2026 could look for different solutions, in particular the local production of Covid-19. vaccines to make them easily accessible to its population. To this end, more than a hundred country governments, noble laureates, international civil societies, philanthropies and non-governmental organizations have campaigned relentlessly and tried to shape public opinion around the world.

Declare knowledge of vaccine technologies including mRNA, DNA, RNA, inactivated viral vectors, protein subunits and know-how as public goods to be placed in the public domain and free exclusivity of patents in accordance with the World Trade Organization (WTO) The 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) turns out to be a request for accessibility of the vaccine. This demand is growing as the conduct of R&D on the vaccine, its production, its rapid ministerial approval skipping the queue, and its fluid distribution are mainly made up of public funds in partnership with a small number of pharmaceutical companies.

Grant temporary exemption from vaccine patents and facilitate the transfer of relevant technology and know-how and the supply of necessary raw materials to low and lower middle income countries (LIMCs) under the pretext of health emergencies and Security exceptions as covered by the provisions of TRIPS are currently on the table as another issue. The vaccine accessibility campaign is also supposed to stimulate the exemption of LDC graduates from patenting pharmaceuticals through the WTO General Council or the Ministerial Conference, as requested by WTO members.

Streamlining vaccine production through compulsory licensing which can facilitate Article 31 formalities and parallel imports under Article 6 of TRIPS is also supposed to end the crisis of vaccines. In addition, enriching the COVAX technology pool with vaccine technology and know-how and facilitating their transfer to LLIMCs or free vaccination of unaffordable people through COVAX are required to compensate for the existing inequality. in terms of vaccines. In addition, bulk intake – active pharmaceutical ingredient (API) – the chemical molecule that follows a specific formulation and set of specifications, including the drug substance and vaccine manufacture together with local partners in these developing countries and PMA, helps reduce manufacturing costs and break the shackles of vaccine nationalism, as evidenced by vaccine manufacturers focusing on production mainly in their respective territories, controlling supply and prices, and not allowing not the transfer of vaccine technologies to other countries. Along with the above, non-commitment to bilateral investment treaties that limit existing and impending patent waivers may also be an option to ensure people have easy access to vaccines.

The recently concluded tripartite memorandum of understanding with the government of Bangladesh, China National Pharmaceutical Group Co., Ltd. (commonly known as Sinopharm) and Incepta Pharmaceuticals Ltd. to produce the inactivated Covid-19 vaccine locally, namely Sinopharm The vaccine developed by Sinopharm / Beijing Bio-Institute of Biological Products Co Ltd appears to be an important step in helping the country produce the vaccine locally. Under the MoU, Incepta would bring in the material in bulk, and the bottling, labeling and finishing of the vaccine would be completed in the country, making the price comparatively very low and allowing easy access to the vaccine. This cooperation is, at the same time, meant to strengthen China’s commitment to “build a great wall against Covid-19” to defeat the pandemic at an early date and narrow the global vaccine gap between high-income economies and weak. This arrangement can also separate itself from vaccine nationalism, at least in terms of bulk supply, manufacturing the finished product according to the production capacity of the local business by employing the country’s cheap labor force and supplying it at home and abroad at a lower price.

This type of vaccine production agreement is the first in Bangladesh, making the country the 25th in the world as a vaccine producing country and it is the 5th in China with the United Arab Emirates, Egypt, Indonesia and Brazil. Such a memorandum of understanding with Bangladeshi society can be seen as China’s commitment to make Chinese vaccines a global public good in its contribution to accessibility and affordability of vaccines in developing countries and countries. PMA in particular, as solemnly announced by Chinese President Xi Jinping at the 73rd World Health Assembly held in May 2020.

However, it is not yet clear whether China will transfer Sinopharm’s vaccine technology and know-how directly to developing countries and LDCs under a technology transfer agreement or refrain from claiming patents. as part of declaring its vaccines as global public goods.

In addition, it is also not possible to know if the MoU contains a clause that could prevent any other Bangladeshi pharmaceutical company with manufacturing capacity from reverse engineering or deformulating the vaccine, that is that is, to identify, quantify and characterize the APIs of the original formula to get the code, refine the model, manufacture with the approval of the department, etc., and supply it to the country and abroad. However, such distortion is allowed as a result of the TRIPS patent exemption for pharmaceuticals until the country’s graduation in 2026 or until a period that could be granted by the General Council of the. WTO or the 12th Ministerial Conference scheduled to be held in Geneva later this year in response to the request for a temporary patent exemption for vaccines or the gradual demand from developing countries for a 12-year pharmaceutical patent exemption.

Thus, in the absence of any clause in the current memorandum of understanding or in the future agreement, whatever it may be, compromising the use by local competing companies of the TRIPS flexibilities already mentioned in the text or in agree in the future, the memorandum of understanding with the Chinese or the like in the future allowing local production and supply of the vaccine at a reduced price compared to the variable prices of imported vaccines will speed up the country’s efforts to make the vaccines Covid-19 easily accessible and affordable for the population not only in Bangladesh but also in other parts of the country the world.

Dr. M Towhidul Islam is Professor, Department of Law, University of Dhaka

Dhaka. [email protected]

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