Poland has failed to garner support from EU capitals for its proposed overhaul of pharmaceutical laws that would curb Big Pharma’s monopoly rights in Europe.
Senior diplomats from EU countries met in Brussels on Wednesday to discuss the position of the Polish presidency of the Council of the EU on the revamp of Europe’s pharmaceutical legislation. But this first attempt to reach a Council agreement fell flat.
Countries are split over the length of time that drugmakers’ new medicines should benefit from market monopoly rights that keep competitors at bay.
Civil society groups have accused the pharmaceutical industry of abusing the current system, and want to rein it in. The sector disputes this, however, and argues the perks must be big enough to entice the industry to invest in Europe.
When Poland took up the presidency in January, smaller EU countries were hopeful that Warsaw could mobilize capitals to curtail Big Pharma’s market protections. This would allow cheaper copycat medicines to flood the market sooner after a new drug is launched, thereby improving access to the latest therapies.
But in a sign that some countries are taking a position that favors the pharmaceutical industry as the geopolitical landscape shifts, a few capitals recently swayed toward backing the sector as Europe’s competitiveness drive hits full throttle.
The split in the Council can broadly be divided into countries that support a seven-year data protection baseline period — keeping the data that underpins a new medicine’s license secret from competitors — versus those that favor eight years.
A dozen smaller and lower-income countries are in the seven-year camp, which Poland proposed, but 10 countries — including Sweden, Belgium, France, Italy, Germany and Denmark — are refusing to budge on eight years, according to an EU official granted anonymity to discuss the closed-door talks.
“Sweden is strongly opposed to shortening the regulatory data protection period for medicinal products,” Acko Ankarberg Johansson, the country’s health minister, told POLITICO. The aim, she said, is to make “the EU more competitive and secure predictable conditions for research-based pharmaceutical companies,” benefiting patients with “the best available medicines.”
Competitiveness is the buzzword in the current mandate, and other countries can also be seen leaning into it.
Ireland and Bulgaria have joined the eight-year camp, giving “the feeling that the momentum is really with eight years,” the EU official said. Both countries were previously willing to support either seven or eight years, the official added.
That leaves countries that initially backed the Commission’s original six-year proposal — such as Estonia, Latvia and Malta — in a difficult position.
While it is 12 versus 10 countries in favor of seven years, decisions in the Council require a qualified majority — meaning that larger countries hold more sway. And with several big countries among the 10 in the eight-year camp, the balance could shift quickly.
“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 second EU diplomat from another country told POLITICO.
Poland will have to go back to the drawing board with its 724-page proposal — or conduct some persuasive lobbying to get other countries to support its plan. The presidency has a little over a month to find common ground before pharma-friendly Denmark takes the helm.
Once national capitals reach a Council agreement, negotiations with the European Parliament can begin.
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