Poland is facing significant challenges in its efforts to reform pharmaceutical legislation within the European Union (EU), as it has not managed to rally support from other member states for its proposed changes aimed at limiting the monopoly rights of large pharmaceutical companies.
During a meeting in Brussels on Wednesday, senior diplomats from EU nations deliberated on the Polish presidency’s stance regarding the overhaul of Europe’s pharmaceutical laws. This initial attempt to establish a consensus within the Council proved unsuccessful, highlighting the divisions among member states.
Division among EU member states
The crux of the disagreement revolves around the duration of market monopoly rights that drug manufacturers should enjoy for their new products, which effectively prevent competitors from entering the market. While civil society organizations have accused the pharmaceutical sector of misusing the existing framework and demand reforms, the industry itself contends that the incentives need to remain substantial to attract investment in Europe.
Upon assuming the presidency in January, many smaller EU nations had high hopes that Poland would successfully unite capitals to limit Big Pharma’s protections. These reforms would ideally facilitate earlier market entry for more affordable generic alternatives, thereby enhancing access to innovative treatments.
However, as geopolitical dynamics shift, certain countries appear to be aligning more closely with the pharmaceutical industry’s interests. This change is evident as some nations have come to favor the sector, aligning with the broader drive for competitiveness across Europe.
Competing proposals on data protection
The Council’s divide can be categorized into two camps: those advocating for a seven-year data protection period, which Poland supports, and those insisting on an eight-year term. The former option is backed by a coalition of twelve smaller and lower-income nations, while ten countries, including Sweden, Belgium, France, Italy, Germany, and Denmark, insist on an eight-year period.
“Sweden is strongly opposed to shortening the regulatory data protection period for medicinal products,” said Acko Ankarberg Johansson, Sweden’s health minister. She emphasized the need to ensure “the EU more competitive and secure predictable conditions for research-based pharmaceutical companies,” which ultimately benefits patients with “the best available medicines.”
The notion of competitiveness is prevalent in current discussions, with nations like Ireland and Bulgaria recently joining the eight-year camp, suggesting a potential shift in momentum. Initially, countries like Estonia, Latvia, and Malta supported a six-year proposal, leaving them in a precarious position as negotiations progress.
Despite the current tally of twelve countries favoring seven years against ten for eight, the Council’s decision-making process requires a qualified majority, which favors larger countries. With many significant players in the eight-year camp, the scales could quickly tip.
“If Europe wants to be attractive for companies, we need to create the right conditions. The question is, how far should we go and at what cost?” a diplomat from another EU country remarked.
As the Polish presidency faces a tight timeline of just over a month to find consensus before handing over leadership to the more pharma-friendly Denmark, it may need to revisit its extensive 724-page proposal or intensify lobbying efforts to gain support from other member states. Only once a consensus is reached can negotiations with the European Parliament commence.