Nepal has reportedly decided to go for the mass clinical trial of the anti-COVID-19 vaccine only after thorough study and analysis of the results of tried out phases and prognostication of likely effects to emanate from the proposed new testing and trials. The decision to allow such testing only after the analysis of its advantages and disadvantages, according to the news item, came reportedly following the suggestions churned out of the consultations with experts, physicians and other stakeholders held at the initiative of Nepal Health Research Council (NHRC), the other day. According to the earlier reports, novel coronavirus vaccines being developed by different companies from the countries including the UK, India, China and Russia have approached Nepal government through some channels expressing their intent to conduct the third phase mass clinical trial to ferret out and confirm their efficacy.
Hope of vaccine The news that the anti-corona vaccines will be trialed in Nepal inspired hope and optimism of the layperson like this author. The naïve hope rested mainly on the grounds namely that the scourge of coronavirus would be reined in on through such vaccines for which Nepal will have an opportunity to lend a genuine and well recognised participation. Another positive aspect as thought out by the commoners is that Nepal will be entitled to access the vaccines easily if it offered an ambient facility for undergoing the clinical trial in the country It is reported in the media that over several dozen pharmaceutical companies are in a race to produce the anti-COVID-19 vaccines. In a confusing move, Russia claimed that its state-owned company named Gamalaya research institute of Epidemiology and Microbiology has produced the world’s first COVID-19 vaccine. According to the media reports, Russia’s Ministry of Health issued what is called a registration certificate for a vaccine candidate that has been tested in just seventy six people. Likewise, Oxford University, supported by AstraZeneca pharmaceutical company, has been one of the leading candidates in the race for producing the vaccine, which is currently said to be in phase III of its trials and considered to be the first one to get launched for the public in 2020s. Currently, the phase III clinical trials are being conducted in research facilities across the UK, US, Brazil and South Africa. Trials have also started in India in partnership with Serum Institute of India. World Health Organisation also asked top vaccine makers in the race to be a part of its global vaccine alliance to ensure equal distribution of the doses for the public. At this backdrop, it can be argued that Nepal should not hesitate to join in the collective global endeavour to test and finalise the efficacy and effectiveness of the anti-corona vaccines as a member of the community of nations. In fact, joining in the global quest for anti-COVID-19 vaccine brings in several advantages, too, as this will be undertaken under global rules of the game. Moreover, from technology transfer point of view also Nepal may get various kinds of benefits. This may include material, medical and capacity building support which will go a long way to strengthen our testing facilities and medical personnel. But this does not mean that we should be allowed to reduce ourselves into guinea pig at the hand of multinational pharmaceutical companies. We should not be seduced by the lure of the multinational companies without considering health risks involved especially in those people who volunteer for the trial. There may be several ethical and human rights issues needing proper consideration. Moreover, the race for producing the vaccine has been played out as a matter of global strategic competition and rivalry. The plutocratic commercial interest is underneath it. All these should be weighed in before allowing the companies to mass trial vaccines in Nepal. Considering all these aspects, time has come for Nepal to formulate an updated policy guideline in regard to vaccine trial for both domestic and international companies. However, policy guideline should not be formulated without comprehensive set of data and evidences generated through research and broad-based structured stakeholder consultation. According to Dr. Deepak Khadka, head of the Research Division of the Policy Research Institute (PRI), a government-owned think tank of Nepal, the policies can become sustainable and implementable only when they are formulated in complete and foolproof adherence of the policy research cycle. Dr. Khadka, who is a molecular geneticist and had participated in the NHRC-led consultation, in conversation with this author, emphasised that Nepal should go ahead in reviewing and revising the existing clinical trial guideline enacted almost fifteen years ago and formulate the new clinical trial policy guideline to end the state of inconsistencies, ad hocism and indecision. Since the need of such an updated policy guidelines to address the challenges of the prevailing situation has already been felt, it is right time to proceed ahead to revise the existing guideline and formulate the newer one supported by well thought out evidences and context specific information.
Transparent policy Such policies already in use and application in other jurisdictions can also help us in designing the relevant one in our context. The relevant and updated state policies and guidelines can better clarify, explain and inform those institutions and companies seeking to mass trial anti-COVID-19 or other vaccines and get to know beforehand about what they need to meet and fulfill, while and after conducting the trial. This is also an imperative of democratic governance to have a transparent and predictable policy guideline in place which is appropriately legislated and applied with reference to the democratically and deliberatively informed policy research cycle.
(Rijal, PhD, contributes regularly to TRN and writes on contemporary political, economic and governance issues. email@example.com)