IPR protection on seven billion doses of Covid-19 vaccine

The Covid-19 pandemic is probably the most profound experience for all of us in living memory, which has created much despair and catastrophe. In the past there were a number of virus outbreaks throughout the globe but I believe Covid-19 is the first one in which countries like Bangladesh have been facing and feeling its direct impact, both on the health and economic frontiers.

In addition to a number of precautions we have taken, with respect to recovery, the news of a vaccine has given us some hope and belief that we will soon be able to exit this disaster and lead a normal life in the coming year. But, still, it is not a time to be complacent and upbeat, for a number of reasons. 

There are some complexities surrounding intellectual property rights (IPR) issues, increased pricing, quality concerns, and the availability of vaccines, administrative procedures and other related areas, including different protocols developed by the World Health Organization.

It appears, from different press and media reports, that 196 different vaccines are being developed in different countries. Some of them are ahead in the race: Novavax, Johnson and Johnson, Moderna, Pfizer AstraZeneca, Sinova, Sinopharam, and the Murdoch Children's Research Institute. It is expected that these companies will be able to sell their products soon. 

Bangladesh is also a part of this race as Globe Biotech Limited initiated its vaccine trial and is trying to develop Bancovid, but it has become uncertain due to procedural complexities with clinical trials. It recently scrapped a deal with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) due to an inordinate delay in developing the protocols for clinical trials. 

Now the company is looking for a new contract research organisation. Our neighboring country India is also trying, and we have heard that Bangladesh also signed a memorandum of understanding with an organisation for 30 million vaccines. The governments of different countries are in a fierce competition to ensure the fastest availability of quality vaccines for the welfare of their people. 

In line with this, at the 31st special session of the United Nations (UN) General Assembly held on 3 December, 2020, Prime Minister Sheikh Hasina sought urgent attention and further collaboration to defeat the pandemic. She made an avid call to save lives and accelerate economic recovery. 

She raised three very important points – one of them is to ensure universal and equitable access to a quality Covid-19 vaccine. In this connection, she requested a transfer of technology – as per Article 66.2 of the Trade Related Intellectual Property Rights (TRIPS) Agreement – from developed countries to developing countries, to manufacture the vaccine locally. 

Bangladesh should try to speed up its activities through its own intellectual property offices for an urgent response to the Covid-19 pandemic to address intellectual property barriers. Photo: Bloomberg

She further requested that developing countries be provided with financial assistance to face the challenge of addressing the pandemic. Referring to the 2030 Agenda for Sustainable Development, which recognises the fundamental role of universal health coverage for all by the principle of equity, her call was made while the whole world is anxiously waiting for a vaccine to save the lives of millions and billions of people. 

We would like to extend our special thanks to our beloved and courageous prime minister for her important and timely call through her valuable speech at the UN General Assembly and very rightly she raised intellectual property rights (IPR) issues and referred to the 2030 agenda. IPR issues have been raised on several occasions and are well discussed at the World Trade Organization (WTO) but have not yet been resolved.

So far, we are aware that 37 countries have pledged their special support to sharing IPRs in the fight against the novel coronavirus – but key players are missing. IPRs rest mostly with private sector developers. They set the price to recover costs where most cases remain unknown to the public. 

On October2, 2020, India and South Africa submitted a proposal to the WTO to ease IPR barriers that restrict access to Covid-19: medicines, tools, equipment, and vaccines. Following this appeal, the Progressive International Covid-19 Response Working Group also, on 5 October, 2020, requested members of the WTO to remove IPR barriers and ensure a legal system for an accelerated technology transfer and equitable access to Covid-19 diagnostics, treatment and vaccines.

When  a company gets a patent right, the first thing is the question of prestige. But the cost for research and development of the new innovation matters, and this is calculated into the price of the product.  Patents create a legal exclusion for 20 years for invention in the form of products or the process of making them. 

Countries are free to prepare their own laws as per the guidance of the World Trade Organization IPR agreement, as articulated in section 8. Because of IPR protection the cost of vaccines will remain unbearable for a significant number of people who are really in need of it and have waited for a long time. There is an urgent need to find alternatives in that respect.

In the TRIPs Agreement there are a number of flexibilities, now it is a matter of questioning how to utilise the flexibilities following the rule book prescribed by the WTO. In Article 27, the agreement excludes from patentability services like diagnostic, therapeutic and surgical methods for treatment of human and animals. While in Article 31 of the agreement there is a provision for a compulsory license system.

This scheme is given full legal force by the latest Article 31b of the TRIPS Agreement. It makes it possible to produce and distribute low-cost generic drugs under a compulsory license solely for the purpose of serving the needs of countries that are unable to manufacture those products themselves. 

Without the permission of the patent holder, a compulsory license is given by a government authority or a court to allow certain use of a patented invention. This process is commonly present in most patent laws, is accepted under the TRIPS Agreement as a legitimate choice or flexibility, and has been used in the pharmaceutical sector by a number of WTO representatives. 

However, TRIPS rules originally restricted compulsory licenses to serve mainly the domestic market, unless they were issued to deal with anti-competitive behavior. In that respect some research can be initiated by the concerned organisation under the Ministry of Industries.

Ecuador and Chile have issued compulsory licenses for pharmaceutical products related to Covid-19 – lessons from them could be helpful for us. 

Meanwhile, the information available thus far indicates that as a result of the Covid-19 pandemic, 80 countries and separate customs territories have adopted export prohibitions or limitations, including 46 WTO members – 72 if EU member states are counted individually – and eight non-WTO members. Most of these have been defined as transitional measures. Some of those limitations have already been withdrawn by at least two members. 

The products covered by these new export bans and restrictions differ widely, with the majority concentrating on: medical equipment (e.g. facemasks and shields), pharmaceuticals and medical instruments (e.g. ventilators), while some are applying regulations to additional products such as food and toilet paper. 

During the pandemic, these types of restrictions need a new policy from the WTO, to ensure transparency and the availability of up-to-date information.

Bangladesh needs to start working on several fronts and continue efforts to collect the right kind of vaccine available for the people of the country from different sources, as the Ministry of Health is currently doing. 

Secondly, the country should try to speed up its activities through its own intellectual property offices for an urgent response to the Covid-19 pandemic to address intellectual property barriers, especially concerning patents and trademarks. At the same time, providing practical support for firms seeking to develop products of potential benefit in combating the pandemic is also needed.

Ferdaus Ara Begum, CEO, BUILD, a PPD Platform that works for private sector development

Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the opinions and views of The Business Standard.