Foreign drugmakers denounce Łapiński plan as anti-market

The Health Ministry's policy toward foreign drugmakers is discriminatory and violates the basic principles of the European Union, representatives of multinational pharmaceutical firms told the WBJ last week. "We've raised the issue with the European Commission," said Brian Ager, the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA). "The ball is in the commission's court now." According to the EFPIA, the recent changes in the government's drug reimbursement policy discriminate against foreign drugs. Health Minister Mariusz Łapiński threatened to cut state reimbursements for about 300 foreign drugs earlier in the year if producers didn't lower their prices substantially. Following weeks of wrangling last spring, most foreign drugmakers dropped their prices, and the ministry maintained subsidies for most of the 300 drugs. Now Łapiński is preparing to launch a program that would allow pensioners to buy select Polish pharmaceuticals for a single złoty. That plan has foreign drugmakers seeing red - again. "It's an absolute discrimination against foreign entities," said Aleksander Wattin, the vice president of the Association of (International) Pharmaceutical Companies' Representatives in Poland (SPFFwP). "We have doubts whether the project is compliant with the Constitution, as it implies unequal treatment of entities," Wattin said. He added that the association's lawyers would give their opinions on the matter this week.

But EFPIA officials are already outraged. "A policy like this runs against the fundamental principle of the European Union, which is to create a single market," said Lukas Pfister, who is responsible for EU enlargement issues at EFPIA. The Health Ministry's policy is in breach of the EU's principle of free movement of goods, Ager said. "The minister is implying that trade flows (between Poland and EU members) should be limited, and I don't think one can pursue this line," he said. "It's against a basic tenet of the enlarged European Union." Discriminating against foreign drugmakers may affect Poland's accession negotiations with the EU, even though talks on the free movement of goods have already been closed, Ager said. "These issues can be reopened," he said. While Poland isn't required to follow EU law prior to joining, every candidate country must show that its legislation is compliant with the bloc's, Pfister said. Poland already has an association agreement with the EU, and the government's policy of preferences toward Polish producers violates its provisions, he said. "The agreement prohibits any measure of the government, be it an act or practice, that has an effect of a quantitative restriction on the market," Pfister said. European drugmakers are seeking the support of the European Commission, but the body has yet to take a stand on the issue, EC officials said. "The compatibility of the draft bill with the association agreement cannot be judged at this stage," said Gunnar Wiegand, the commission's spokesman for external relations. "The commission will need to see the legislation." The EC had asked Polish authorities for clarification following a meeting between the two sides earlier this month, he said. It is now waiting for the government's reply. "The issue is highly blurred on both sides," said an EC official who asked not to be named. "It's a good case for lawyers." The official noted that there is no EU law against verbal statements by politicians, while April's struggle between Łapiński and foreign drugmakers occurred mainly in the media and at the negotiating table. And the "drugs for one złoty" project is still in the concept phase. The EFPIA would have to prove that the ministry's measures would negatively affect producers' revenues, the EC official said. The case will require a separate legal analysis, according to Cyril Jacquet, a lawyer at the EC's directorate general for the internal market. But he said that governmental pressure could also be considered discriminatory.