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.”