Safeguarding innovative research without patent protection

Issue and background

The need to obtain and to hold the marketing authorisation for a drug can be one important example for a situation where results from scientific studies have to be made available after the period of patent protection has already expired. Without studies that follow the progress in medical scientific research the evidence, which is the basis of the marketing authorisation, is in danger of being out of date. It is specific to drug licensing law that applicants can refer to the data submitted by an original marketing authorisation holder to enable generic products to be marketed. This reference is made without any participation in the cost of these studies.

In Europe, such reference can be made immediately after the competent authority has received the new data. One important consequence is that it is very difficult, from an economical point of view, to decide to invest in studies of products without patent protection as competitors can refer to the results of the studies without having invested in them financially. This is very relevant as clinical trials typically require funding of one to ten million Euros. And this has direct impact also on medical research with therapies of this kind, because it is the clinical scientists that receive the biggest part of these funds. Also, the patients and their physicians are involved as they probably lose therapies they used safely and effectively in the past and which now will have to be substituted by alternatives that usually cost more.

This is the situation for any non-patented drug independent of the nature of its active substance. However, in particular, it is relevant for herbals which have drug status in many European countries because these substances typically cannot be patented.

Statements and roundtable discussion

• Legal background concerning intellectual and industrial property law and examples for the socio-economic and political impact of possible solutions of the problem (Dr Ensthaler).
• Are international solutions available and preferable? (Dr Meng).
• Impact of the problem on medical research and on the ageing process of drug therapies with special respect to complementary and alternative medicine (Dr Goldman).
• Aspects of the discussion of the problem within the European Institutions, status and possible future development (Dr Sickmüller).

The audience is invited to contribute to the discussion.