Compulsory Licencing Of Bayer's Cancer Drug Is An Achievement

Image: Amit Verma

Nata Menabde
Age: 52
Designation: WHO Representative to India
Education: MSc in Pharmacy, PhD in Pharmacology
Career: Nearly 20 years at WHO; was deputy regional director for Europe before coming to India in 2010
Interests: Plays the piano and guitar. Likes classical music, jazz, water sports, history and Russian literature


Q. What are the top three challenges in healthcare in India?
Communicable diseases remain part of the unfinished agenda for India, particularly those that are affecting mortality and morbidity of mothers and children as well as some of the others that prevent India from reaching its Millennium Development Goals. For children, respiratory diseases, vaccine-preventable diseases and tuberculosis are big challenges.

The [second] is the totally new trend where non-communicable diseases—cardiovascular, cancers, whole group of chronic diseases—are growing very fast among the ageing population, hitting hard the economy, development and future prospects of India.

The third one is the health systems agenda and the changes that are required, particularly, the universal healthcare agenda that is currently being debated.  

Q. What do you think of the Controller General of Patents recently issuing a compulsory licence for Bayer’s patented cancer drug?
We are supportive of any measures that any government can take to improve access to life-saving drugs. The provision of compulsory licencing which is given in the WTO’s TRIPs [Trade Related Intellectual Property Rights] agreement is included in Indian legislation as well, but that provision had never been applied in practice. That is quite sad, because on many occasions such bold actions can make a great difference to people who need these therapies. As a creation of precedent, this is a great achievement for India’s public health. Therefore we definitely support movement towards using all the measures available, be it legislative, managerial or political, to address the needs of the people. So, we welcome India’s move. It is also a good message to the industry that the India government is now mature enough to consider all the options it has and apply them as appropriate for the needs of its people.

Q. Wouldn’t it affect drug research and introduction of new drugs?
It is an issue that deserves careful consideration. Indeed some of the measures that are jurisdictive in nature can discourage availability of newer products, and especially hit new research. We all know that and we at the WHO are sensitive to that. We also know that industry, the pharmaceutical industry in particular, is a partner for us and for governments all over the world because without research and investments by private manufacturers mainly, we won’t have access to newer products. At this point of time, the pipeline for new pharmaceutical products is not very large compared to a couple of decades ago when we had a lot innovations. And there are still some diseases, which are un-tackled and are major killers in terms of world numbers but are predominantly in middle income or low income countries. Therefore, if these markets do not purchase these drugs then it is not so interesting for investors to put money to come up with new drugs.

There are a number of these issues where the right balance is very important. I do believe that any government that introduces such measures, which on one hand can negatively influence development of new products, should be really thinking how to open up some other opportunities to balance it so the legitimate interest of any industry to make profit does not become impossible. We are sensitive to those issues.
 
Q. Does India have enough healthcare regulation?
India has abundant healthcare regulation. Perhaps it does not have all the regulation it needs in all the areas and perhaps it has regulations that it does not need anymore. India needs to have a deep look at regulations in various parts of the health sector and bring them to the level of today’s needs. That also includes looking at the private sector service delivery, quality standards, accreditation issues, monitoring, professional standards—these are many issues that require a careful look. India has a lot of good, well-meaning regulations, but lacks enforcement mechanisms, especially because of the political structure of the country where health is the responsibility of the states. It is not always working for the good of the people. I am not promoting centralisation of health regulation but I think much more needs to be done to be sure that there are proper mechanisms for enforcing them. It is a big area and that includes having management information systems, managerial and supervisory capacity and having a sense of accountability in all the players in the system.