R&D: What Novartis says . . . and why it’s wrong4 min read . Updated: 12 Apr 2013, 01:12 AM IST
Increasing evidence over the last decade has pointed to the patent system being a bottleneck for research itself and access to affordable medicines
A critical legal battle over what merits a patent, involving Swiss drug maker Novartis AGand India, occupied centre stage in the media across the world this month. The 1 April Supreme Court decision recognized that India’s tougher patentability standard (Section 3 (d) of the patent law) was designed with the legislative objective of stopping evergreening, a common patenting practice in the pharmaceutical industry aimed at filing and then obtaining separate patents relating to different aspects of the same medicine.
The outcome of the battle over cancer drug Glivec brought relief to developing countries that rely on affordable, quality generic medicines produced in India, the prices of which are a fraction of what multinational companies charge governments and patients.
In the wake of the Supreme Court verdict, Novartis, other big pharma companies and, now, the US Chamber of Commerce, have decried the decision, saying it discourages investment in research and development (R&D) in India. This argument is seriously flawed as is the patent system itself!
It is true that new drugs and diagnostic tools can revolutionize public health programmes and we need more of them for the patients. Doctors Without Borders (Médecins Sans Frontières) treats drug resistant tuberculosis (TB), HIV, malaria, kala azar and other diseases affecting people in developing countries. Contrary to what Novartis claims, patient networks and health groups in India advocate, rather than oppose, efforts to meet needs-driven R&D.
But the current system, in which a company is granted a 20-year patent monopoly on a drug to allow it to recoup costs in researching and developing the drug, is proving to be a hindrance, not a help, in addressing the health needs of developing countries. The diseases and health issues of developing countries are neglected by companies, and access to the drugs that are available is difficult and expensive. Increasing evidence over the last decade has pointed to the patent system being a bottleneck for research itself and access to affordable medicines.
A number of studies has shown that while patent protection has steadily increased over the last 20 years, the innovation rate has been falling, with growth in the number of “me-too" drugs of little or no therapeutic gain. A breakdown of over 1,000 new drugs approved by the US Food and Drug Administration between 1989 and 2000 revealed that over three-quarters had no therapeutic benefit over the existing products.
Perhaps, most tellingly, the World Health Organization (WHO) has published several expert reports over the last decade that undermine the claims made by the pharmaceutical industry that more patent protection in developing countries would result in more investment in medical innovations for public health needs.
It is clear the current system doesn’t work in developing new drugs or adapting existing drugs to address the unmet needs of patients in developing countries. Drug development by pharmaceutical companies is split between blockbuster branded drugs and “me-too" patented variations on existing drugs that involve less risk, time and cost. Anything promising that doesn’t fit within either of these categories is abandoned.
Instead, development of drugs and tools for malaria, tuberculosis and other neglected diseases that address needs in developing countries has largely been left to philanthropic efforts and foundations such as Drugs for Neglected Diseases Initiative (DNDi).
Novartis’s criticism of the Supreme Court decision opens up a timely debate on the R&D crisis. A new approach to pharmaceutical R&D is the order of the day. A number of measures have been proposed to promote the R&D needed to address the diseases that disproportionately affect developing countries.
Crucially, the discussion at WHO among member countries has recently centred on a biomedical R&D treaty that would provide the framework for ensuring that sufficient, regular, predictable and sustainable financing is secured to spur innovation of affordable and much-needed medicines and tools for developing countries.
As treatment providers, this is our prescription to the Indian government—push for an international instrument that de-links R&D costs from drug prices, not on increasingly high intellectual property standards, where products are exorbitantly priced in order to recuperate the costs of R&D.
As James Orbinski, the then president of the International Council at Doctors Without Borders, said in 1999 in the Nobel Peace Prize acceptance speech on behalf of the organization: “Some of the reasons that people die from diseases like AIDS, TB, sleeping sickness and other tropical diseases is that life-saving essential medicines are either too expensive, are not available because they are not seen as financially viable, or because there is virtually no new research and development for priority tropical diseases.
This market failure is our next challenge. The challenge, however, is not ours alone. It is also for governments, international government institutions, the pharmaceutical industry and other NGOs (non-governmental organizations) to confront this injustice. What we as a civil society movement demand is change, not charity."
Leena Menghaney works in India for the Access Campaign, set up by Doctors Without Borders in 1999 to push for access to, and the development of life-saving and life prolonging medicines, diagnostic tests and vaccines for patients in its medical programmes and developing countries.