Pharmaceutical law

From 12 to 14 March, our Law Office organised an expert workshop on pharmaceutical law.

The workshop was organised in co-operation with the Czech Bar Association within the international AIJA organisation. The conference was held at the Dunaj Palace in the presence of over 50 participants from twenty different countries. The topics, relating to pharmaceuticals and the associated legal issues, were divided into six blocks completed on Friday and Saturday.

The first block concerned various aspects of laws on pharmaceuticals. Pavol Mazan from the Wyeth company presented an overview of the issues encountered by pharmaceutical companies in their practice. His presentation was followed by a lecture on restrictions on the advertising of pharmaceuticals and a lecture on the legal regulation of the use of human tissues and their substitutes.

The two blocks that followed focused on intellectual property law, particularly patent protection. Sune Larsen of the Pharmaceuticals Sector Inquiry Task Force, the European Commission, presented the findings contained in the preliminary report on the sector inquiry. She emphasized particularly the Commission’s concerns regarding the attempts made by patent owners to prolong the duration of patent protection in excess of the existing legal framework. Other lecturers also presented their views on this topic, outlining the options permitted by the legal regulation in the EU countries, in the United States and in the Middle East. Other aspects discussed in this part included the legal regulations on the sale and distribution of pharmaceuticals. Within these blocks, the participants also discussed the aspects of parallel sale and Internet sale of pharmaceuticals.

The fourth and last block held on Friday covered the topics of economic competition. The aspects of competition law associated with the sector inquiries undertaken by the Commission proved to be much more complicated than expected, because the Commission’s preliminary report deals with competition law only marginally.

The lecturers addressed the case-law of the European Court of Justice having impact on parallel sale. Overviews of the recent acquisitions in the pharmaceutical industry were also provided in this part.

On Saturday morning, the conference proceeded with the current problems in the countries of Central and Eastern Europe. The lecturers from the Czech Republic included attorney-at-law and pharmacist Vladimír Bíba and lawyer Ondřej Dostál. They concentrated particularly on the determination of prices and the methods of payment for pharmaceuticals in the region. The lecture given by Michala Blažková of the Civic Association of Patients with Idiopathic Inflammatory Bowel Disease incited an interesting debate about the delicate relationship between the pharmaceutical industry and patients’ organisations.

In the last block, the participants dealt with the regulation of various countries in respect of civil and criminal liability that may arise in the production, sale or prescription of pharmaceuticals. On this occasion, the participants vividly discussed the permitted scope of the provision of various small gifts for doctors, ranging from company pens to invitations to workshops held in exotic destinations.

In conclusion, the participants spontaneously agreed to create a stable international task force within AIJA, comprising lawyers who are concerned with pharmaceutical law throughout the world. Given the global scope of the pharmaceutical industry, this appears to be a logical response by those lawyers who wish to provide high-quality advice in this area.