‘‘Research funders can focus on diseases which are not of interest to pharma companies’’

The World Health Organization (WHO) which has brought out an extensive document on Genomics & World Health is now in the process of sensitizing member countries on the intricacies. Dr Tikki Pang, Director, Research Policy & Cooperation, WHO, Geneva, was in the country recently to participate in a seminar on Genomics organized by the Indian Council of Medical Research. Dr Tikki Pang, who is also the author of six books and 180 odd scientific articles, in an exclusive interview with Jayashree Padmini.

What are the potential gains from genomics research and what is WHO’s strategy to ensure access to these to the population across the globe?

Genomics research would unlock enormous gains, especially in the field of infectious diseases in terms of new vaccines and better diagnostics against intractable diseases like malaria, TB and HIV/AIDS. WHO has chalked out a two-pronged strategy to take on the genomics scene unfolding. One is to directly support research into applications of genomics research in this field through our TDR (Tropical Diseases Research) programme. The other move is advocacy & promotion, like what we have been doing through the Genomics & World Health Report and providing a platform for interested stakeholders to work out feasible solutions.

How does WHO plan to address the multiple issues associated with genomics research ranging from ethical and social concerns to legal implications? What are the appropriate regional strategies?

WHO’s main role is in advocacy and is catalytic. In this task, it will work closely with its six regional offices and its Member States, and with other international organizations such as WIPO, FAO, WTO, UNESCO. The appropriate regional strategy is for countries in the regions to work closely with academies of medicine, scientific societies, community groups, religious leaders and civil society.

The drug research scene is tilted towards potential market opportunities and the research-spend flowing to the whole gamut of neglected diseases is at an abysmal level. In this context, how do we ensure R&D for diseases specific to third world countries?

This is a difficult issue as it is clearly difficult to persuade pharmaceutical companies to develop products for which market potential is minimal. Providing incentives like guaranteeing purchase, market access are one approach and innovative partnerships as well as ‘tiered’ pricing where companies charge according to the ability of the country to pay could be other options. The other side of the coin is that research funders (bilaterals, foundations, philanthropies) can focus on the diseases which are not of interest to pharmaceutical companies.

Genomics and proteomics have aroused much enthusiasm across the globe and already companies have stepped into this arena like corporate hospitals utilizing the patient data through their genomics research outfits. What norms should be in place in countries like India in this situation? And how do we sort out IPR issues?

This is a major concern and, with respect to norms, must be dealt with through the establishment of a national regulatory framework which will provide guidelines, set norms and standards, and also monitor compliance. Such a framework should be established with the participation of all concerned parties. IPR issues need to be sorted out at the international level and should involve other organizations like WIPO and WTO. There is much debate on this. Also notable is, some of these ideas from a Nuffield Council of Bioethics Report on ‘‘The Ethics of Patenting DNA’’ on how to ensure IPR’s benefit to developing countries. It proposes that not all gene sequences should be patentable and strict criteria be applied before DNA patents are awarded.

How do we balance between IPR protection of private funded research and accelerated research to derive the benefit for all?

The IPR issue is a highly complex one and it is not easy to get the appropriate balance. There is also some recent work indicating that patents are not actually a necessary pre-requisite for innovation, thus debunking the old argument that patents are a necessary incentive for commercialization of products.

How long would it take to get the potential results of the research and the research itself appears to be technology-driven rather than health-focussed?

The timelines for realizing the potential results are hard to predict, I would say that the more immediate benefits will be in the field of diagnostics and vaccines for infectious diseases, with novel therapies for more complex, multi-factorial disorders being in the more distant future.

The real challenges involve determining the cost-effectiveness of new, DNA-based tests and interventions (as opposed to traditional methods) and understanding the complex contributions of genetic factors in multi-factorial disorders.

What are the parameters by which a country should judge on its research priorities and how could it strike that balance when research direction is decided by MNCs?

Some of the parameters would include disease burden in the country, available infrastructure and human resources. It is correct to point out that it is difficult to strike a balance when MNCs dictate research direction, hence this is where national health research councils (eg. India’s ICMR and CSIR) play a crucial role as a counter balance.

Information and data on a specific patient passes through different people and sections in a hospital. Here what should be the level of confidentiality in a country like India? How significant is it and what could be the impact, if it is diluted?

Confidentiality should be at the level of the individual in any country, not just India. Safeguards must be in place to protect such confidentiality.

The impact, if it is diluted, is rather obvious: misuse of the information that could lead to discrimination and stigmatization of individuals.

How do we define genetic material in terms of it being in the private or public domain, especially, in third world countries where even the informed consent could mean patient unaware of the full meaning or implication of sourcing genetic material?

I guess this would depend on who collected the genetic material, ie. private companies or public research initiatives. Having said that, some private companies do place genetic data in the public domain where it is freely accessible to all. Informed consent in third world countries is a real problem when education levels are low. One possible solution is to carry out a formal assessment of participants’ comprehension of the consent form as a routine step in the informed consent process in less-developed countries.

Countries like UK has approved human cloning for therapeutic purposes. What is WHO’s view on this? Should third world countries go for this and if so what would be the impact?

I think you need to use the terms with care, because there is a big difference between ‘‘human cloning’’ (or reproductive cloning) and cloning for therapeutic purposes (or therapeutic cloning) which refers to obtaining stem cells from embryos. WHO has officially stated that it is against cloning of human beings; we do not yet have an official view on therapeutic cloning but I would guess we would be sympathetic to ‘cloning’ for therapeutic purposes. The distinction should be clarified to all as this is the most important source of confusion in debates on this issue.

From your interactions with different countries what conclusion you draw as to what are the specific issues that are crucial and what are the challenges ahead?

Issues of intellectual property rights, benefit sharing and protection of vulnerable populations from unethical practices are more critical. The challenges are how do we develop mechanisms to ensure that poor countries are not being exploited. Despite all the cynicism I cannot see anything other than a UN-led initiative as the only way forward. Therefore, a major challenge is how to persuade rich countries to have more ‘faith’ in the UN system (the Americans certainly have very little!!) and provide adequate resources for its functioning.