Critics see conflict of interest in new drug law

The Senate this week is scheduled to vote on a government bill that subordinates the drug approval agency to the health minister. The bill is almost certain to pass the Senate, sources in Parliament said, but opposition MPs and drugmakers denounced the bill, saying that the assessment and approval agency should be an independent body and that the minister's control over it would damage its impartiality. The concentration of market approval and pricing responsibilities under the health minister also counters the separation principle applied by most European Union members, according to Kerstin Franzen, an expert on market approval at the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents EU-based drugmakers. "The body that assesses and approves drugs (for the market) should not be the same as the one that sets the price for these products because pricing may influence the assessment," Franzen said.

Although the EU legislation doesn't regulate an approval body's independence and leaves the decision to member states, most of them have a separate body for approval and a separate one for pricing and reimbursement, said a source in the European Commission, who asked not to be named. "Most member states have an independent agency that is responsible for market authorization (of drugs)," he said. The EU law, however, obliges the national agencies to grant market approval exclusively on the basis of three criteria: the drug's efficacy, safety and quality. For this reason, Franzen said, the agency should be independent of the minister, who decides on prices and governmental subsidies for drugs. If the price of a drug is high, the government would fall under popular pressure to subsidize it to make it affordable to patients once it is cleared for the market, Franzen said. "The assessment of a drug (at the market approval stage) is then not only based on the three objective criteria," she said. Renata Furman, the Health Ministry's spokeswoman, dismissed the criticism, saying that the Polish agency, Office for the Registration of Pharmaceuticals, Medical Products, and Biocide Products (URL) would remain independent. "The agency's president will take his sove-reign decisions based on the dossiers filed by producers," Furman said. But opposition MPs questioned the government's intention to respect the agency's independence.

"The original law (before the government introduced and amendment) envisaged that the agency's president be appointed by the prime minister, not the health minister," said Elżbieta Radziszewska, an opposition MP of the Civic Platform party. "If the minister is responsible for the (drug) reimbursement policy and for (drug) prices, then he shouldn't be the one to decide about market approval." The law that establishes the approval agency was passed last fall under the former Solidarity Election Action (AWS) government. It was scheduled to take effect Oct. 1, but before it could become law the new go-vernment filed an amendment in Parliament that made the agency subordinate to the health minister and gave him the right to appoint and dismiss the agency's president. The Civic Platform voted against the amendment arguing that the agency's president should be independent and take sole responsibility for drug approval decisions. But the government's amendment is almost certain to pass the Senate since the ruling coalition, led by the Democratic Left Alliance (SLD), has 75 of 100 senators who support the government's proposal, Radziszewska said. "The health minister has decided to seize control over everything that pertains to drugs, and this raises concerns whether the decisions on market approval will be impartial," she said.