Ethics Council discusses issues of access to medicines in developing and threshold countries

One third of the world’s population had no access to essential medicines and half of those affected lived in the poorest regions of Africa and Asia, said Christiane Woopen, Chair of the Ethics Council, opening the meeting. How far could mechanisms of the market economy contribute to fairness in the field of healthcare? What responsibility did industry, science and nation states bear for healthcare in developing and threshold countries? Patent protection of pharmaceutical products was especially relevant where these issues were concerned. On the one hand, patent protection was supposed to create incentives for innovation, whereas on the other it was suspected of blocking access to the resulting innovations and of cutting people off from vital healthcare benefits.

Holger Hestermeyer, an international law expert from Heidelberg’s Max Planck Institute for Comparative Public Law and International Law, outlined the legal background to the situation. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) governed patent protection at international level and was binding on all members of the World Trade Organization. The Agreement thus had direct substantive effects for both states and enterprises. Conversely, whereas it was incumbent on states to respect the human right to health enshrined in the International Covenant on Economic, Social and Cultural Rights, there was no provision for citizens to demand its observance before the courts.

Professor Albrecht Jahn, a public health expert at Heidelberg University, took a critical view of this situation. Patent law had not succeeded in inducing the industry to invest its substantial profits in research on new drugs. The Doha Declaration adopted by the World Trade Organization in 2001 made it easier for states to provide access to essential medicines notwithstanding patent protection. For a sustainable improvement in provision, the costs of research and development needed to be decoupled from drug prices. Proposals to that effect had been laid before the World Health Assembly in May 2012 by the CEWG, a WHO working group.

Corinna Mieth, a philosopher at Ruhr University, Bochum, agreed. Although patent protection was ethically justifiable, if there were better options in specific fields for helping people in need without excessively harming the industry’s interests, there was a moral obligation to pursue them. A possible approach might be a model requiring states to allocate a certain proportion of their budgets to research on and the provision of important drugs for the treatment of neglected diseases.

The ensuing debate also focused on the search for solutions. Helge Braun, State Secretary at the Federal Ministry of Education and Research, favoured assistance for research on medicines for which patent protection was relatively unattractive. To this end, the Federal Government had since 2010 been engaged on the establishment of specific research cooperation projects between German and African institutions and was participating in product development partnerships for the development and funding of drugs.

Cornelius Erbe, of Germany’s Association of Research-Based Pharmaceutical Companies, argued that the debate on patent protection was in fact missing the point. The patents on most essential drugs had long since expired, and the reasons why people did not have access to them were primarily a matter of infrastructure, and in particular of logistics. That was where action needed to be taken.

Christiane Fischer, of the BUKO [Federal Internationalism Coordination] Pharmaceutical Campaign, who is also a member of the Ethics Council, took issue with this argument. In her view, it was perfectly justifiable to expect the pharmaceutical industry to manufacture urgently needed drugs and not to obstruct their supply to the population of poor countries by patents.

When the discussion was thrown open to the floor, a particular concern that emerged was the possibility of regulation of the pharmaceutical sector. One suggestion from the floor, to the effect that new incentives for innovation outside the field of patent law should be introduced, met with a wide measure of agreement.

The need now, as Wolf-Michael Catenhusen, Vice-Chair of the German Ethics Council, stressed in his closing address, was to combine the existing models for the further development of patent law in a strategy for structural transformation: “This is an opportunity and an obligation for Germany to be in the vanguard of international development in the field of healthcare research,” he said.

A transcript of each speaker’s contribution and of the discussion can be accessed here (in German).