Poland has encountered significant challenges in garnering support from EU capitals for its proposed overhaul of pharmaceutical laws, aimed at curbing Big Pharma's monopoly rights in Europe. Senior diplomats from EU countries met in Brussels on Wednesday to discuss the Polish presidency's position on the revamp of European pharmaceutical legislation, but initial attempts to reach a Council agreement fell short.
Countries remain divided over the duration of market monopoly rights for drugmakers' new medicines, which prevent competitors from entering the market. Civil society groups have accused the pharmaceutical industry of exploiting the current system and are advocating for reform, while industry representatives argue that substantial incentives are necessary to attract investment in Europe.
Upon taking up the presidency in January, Poland aimed to mobilize support from smaller EU countries to limit Big Pharma's market protections, potentially allowing cheaper generic medicines to enter the market sooner. However, recent geopolitical shifts have seen some countries leaning towards supporting the pharmaceutical sector, complicating Poland's efforts.
The ongoing debate centers around whether to establish a seven-year or eight-year data protection baseline period, which would keep the data underpinning new medicines secret from competitors. A dozen smaller and lower-income countries support the seven-year proposal put forth by Poland, while ten countries—including Sweden, Belgium, France, Italy, Germany, and Denmark—have expressed firm support for the eight-year period.
Ireland and Bulgaria have joined the eight-year camp, creating the perception that momentum is shifting in that direction. This leaves countries that initially backed the Commission’s original six-year proposal, such as Estonia, Latvia, and Malta, in a difficult position.
While there is a 12 to 10 split favoring the seven-year proposal, EU Council decisions require a qualified majority, giving larger countries more influence. As a result, Poland may need to revise its extensive 724-page proposal or engage in persuasive lobbying to garner support from other member states. With just over a month remaining in its presidency before Denmark takes over, the pressure is on to find common ground.
Once national capitals reach a consensus, negotiations with the European Parliament will begin, marking a crucial step in shaping the future of pharmaceutical legislation in the EU.
