Research and development of a drug in the legislative environment in the light of changes which will be brought about by Slovakia’s entry into the EU

Presentation: Story of drug (format .ppt)

The role of intellectual property protection in the pharmaceutical industry

Intellectual property plays an important role in the pharmaceutical industry, because research and development of original drugs is a very demanding process both in terms of finance and time. Investments devoted to research and development of new drugs must have a secured rate of return. Most of the pharmaceutical companies (both generic and original) are joint stock companies, whose shares are freely tradable on the stock exchange markets. On one hand, investors - the shareholders - expect the management of these companies to provide prosperity and sufficient profit. On the other hand, the doctors, patients and their close ones are waiting impatiently for new drugs, which will be able to fight more effectively the known diseases, but also the new ones, which are being discovered even today (AIDS, SARS). This is also the reason why a new legislation is being prepared in the European Parliament that addresses, among other things, also the protection of intellectual property in the field of pharmaceutical products.

European and Slovak legislation addressing the data protection

Since August 1, 2003, when the amendment of the Drugs Law no. 140/98 Z. Z. became valid, the Slovak legislation addressing the area of protection of registration documentation (data) is as follows:

In Slovakia, the law sets the data protection period (data exclusivity - i.e. the time during which it is not possible to use data owned by the original producer for registration of a generic producer) to be six years; this period is set at ten years only for drugs produced by means of the so-called high-tech technology. However, the ten-year protection period now applies only to those drugs that are high-tech and are at the same time registered in the European Union by a centralized procedure. In Slovakia, the ten-year protection period in reality applies only to a small percentage of drugs sold on the market.

In the European Union, the legislation addressing the data protection period for the pharmaceutical industry is determined by the governments of the individual countries. Half of the EU countries apply the ten-year data protection period for all drugs, the rest apply the six-year period, with only some countries applying both alternatives combined. However, Europe is aware of certain weaknesses in the area of the intellectual property protection, especially in comparison with USA or Japan (G10 initiative). That is why investments into research and development are not coming to Europe in many areas, and Europe is preparing to strengthen the intellectual property protection.

In the European Parliament, the amendment of the Directive no. 2001/83/EC is already in its second reading. Currently, it reached a compromising proposition to apply the ten-year protection period, plus one year (for new indication) for all drugs, with a possibility to start the generic drug registration process after eight years, so that it is possible to introduce the generic drug on the market immediately on the date the protection period expires. The goal of this legislative amendment is to provide for a balanced environment necessary for prosperity of both the original and the generic pharmaceutical industry.

Unfortunately, in this regard Slovakia is taking steps in a completely opposite direction than the European Union, which our country wants to join as soon as on May 1, 2004:

The amendment which is already valid decreases the extent of approximation to the currently minimal requirement of the EU, and is in contradiction with the prepared amendment of the Directive no. 2001/83/EC.Thus, following approval of this directive in the European Parliament, there will be a need in Slovakia for further amendment of the Law no. 140/1998 Z. z..