This article is part of the Polish Presidency of the EU special report.
Poland wants to treat its patients with Europe’s newest medicines. Currently, that’s not happening.
As it takes over the presidency of the Council of the European Union in January, the country has an opportunity to pitch an overhaul of the pharmaceutical legislation that would favorably reward drug companies that extend the reach of their drugs throughout the EU.
But Poland also has a time pressure. It has six months to find agreement between EU countries on pharma’s monopoly rights — including incentives to launch new drugs throughout the bloc — before the file passes to pharma-friendly Denmark, which strongly opposes cutting industry’s perks.
It’s a fine balance that the Council of the EU is now trying to strike as it scrutinizes the European Commission’s proposal, which aimed to equalize European citizens’ access to medicines while also incentivizing the pharmaceutical industry to develop the drugs most in need. But attempting to satisfy these two goals under one strategy has split EU countries.
Poland is clear where it stands and it isn’t wasting any time jumping into the discussion. Country reps have openly advocated for reducing the existing market monopoly rights for drugs, which would allow cheaper copycat drugs onto the market sooner.
“It’s more about accessibility to drugs,” Katarzyna Piotrowska-Radziewicz, drug policy and pharmacy director at the Polish Health Ministry, told POLITICO at its health care summit in November. “Not so much about the competitiveness.”
Ensuring timely and equal access to medicines in all EU countries is “our responsibility as a government … (and) the goal of the Polish presidency,” she said.
No wonder: The fifth-biggest population in the EU struggles to access novel treatments. Only 69 out of 167 medicines approved in Europe between 2019 and 2022 were available in Poland in 2024. In comparison, those in Germany had access to 147. The situation is worst in Malta where only six treatments were available, followed by Lithuania which had 14.
Poland feels the responsibility on its shoulders to represent the needs of smaller member countries. “The smaller states are looking forward to the Polish presidency because we are a big country,” Piotrowska-Radziewicz told POLITICO, adding that they “put a little bit of pressure on us.”
While Piotrowska-Radziewicz recognized the importance of innovative treatments, “new therapies are expensive and very often they’re not available on the markets,” she said, highlighting the approximately two-and-a-half-year delay for new drugs to be reimbursed in Poland. “In some smaller countries, they are not entering the reimbursement system at all,” she added.
Rich vs. poor split
Pharmaceutical innovations are rewarded with 20-year patents. As patents are filed early in a drug’s development, the effective patent life of a medicine once marketed is around 13 years on average.
Currently, on top of patent protection, all innovative medicines have eight years of regulatory data protection — preventing competitors from accessing the data underpinning the medicine’s license and reusing it. They also get up to three years of market protection. This “one-size-fits-all” system is what the Commission has changed in its revamp of the 20-year-old rules.
The Commission proposed to reduce the eight years of data protection to six years. They can be earned back by fulfilling public health objectives such as making the drug accessible in all 27 countries, developing medicines that address unmet medical needs, conducting comparative clinical trials and producing medicines that can treat other diseases as well.
Reducing data protection by two years may reduce costs for health systems and payers. The Commission’s impact assessment by Technopolis found it would cut annual costs for public payers by €1.13 billion and stimulate the generics market with an additional profit of €266 million per year.
“The pharma sector — the pharma market — changed” and drug costs are soaring, a senior diplomat from a Central European country close to the matter told POLITICO. “We need to modulate. We need to set conditions. The eight years cannot be given unconditionally in the future. It’s a reality. So are the members willing to accept this?”
Poland is all for it. The country is supporting the so-called modulation system, slashing the data protection period for new drugs to six years from eight and pushing the industry to have pricing and reimbursement talks with all 27 countries.
However, not all countries are on board. While the majority want to have conditional market rewards, they are blocked by a minority of pharma-friendly countries.
“There are countries [like] Poland who have a problem with accessibility of medical products … [and] are more open for negotiations,” Piotrowska-Radziewicz said. “And there are … bigger, wealthier countries who are not eager to negotiate.”
These are Sweden, France, Italy, Germany and Denmark blocking the new reward system. The biggest task for Poland in this presidency will be to move the positions of the “wealthiest countries … [that] would like to remain with the status quo,” she said.
Meanwhile, only a minority of countries support the Commission’s pitch to reward market access.
Around 60 percent of countries didn’t like the Commission’s proposal “because it makes the whole system very unpredictable,” the diplomat said. The minority of countries that support it include the Baltics, Cyprus and Slovenia.
It’s been the trickiest part of the text with both the Belgian and Hungarian presidencies proposing alternative ways to improve access to new, costly drugs.
The latest proposal — from the Hungarians — obliges a company to begin pricing talks if a country requests it. If the company fails to respond or meet the agreement it could risk losing market protection in that country.
However, countries such as Italy and Germany are unhappy with the Hungarian model. “If the obligation is not supported, then what?” the diplomat said, questioning whether some were even willing to accept that Europe has to improve the access issue in small countries.
“This is a huge political responsibility,” the diplomat said.
Piotrowska-Radziewicz is hoping that the Polish presidency will be “as creative as the Hungarians” to ensure that access is guaranteed within the package.
The next presidency
One of the countries that is refusing to budge is Denmark — which will hold the presidency after Poland. The country is largely bankrolled by the pharmaceutical sector with obesity drugmaker Novo Nordisk now the highest-valued company in Europe.
Denmark opposes cutting data protection and objects to the modulation system. “We don’t feel that the modulating will provide the results that the Commission is hoping for,” Edward James-Smith, head of EU affairs at the Danish Ministry of the Interior and Health, told POLITICO at the health care summit, highlighting that this might not be the way to ensure access.
He pointed out that countries should pool their resources, “especially smaller ones, with joint tenders” and raised the issue of “very little transparency” on pricing.
While both Poland and Denmark have widely different views, as presidencies they will be tasked with finding common ground — and pushing for national interests might be difficult with everyone’s eyes on them.
“It would be obvious that they are not honest brokers,” the diplomat said. “The first time Denmark comes up with eight years, Poland comes up with six years, they will lose credibility.” As a presidency, “we have to be a broker” who finds that middle ground.
Poland might reach the negotiation phase, but the Danes might progress to talks with the Parliament.
But with a rise in right-wing governments since the launch of the pharmaceutical strategy in 2020, countries might shift more toward Denmark’s position, Elizabeth Kuiper at the European Policy Centre think tank, said.
“Right-wing governments … tend to be more business-friendly,” Kuiper said. “These political changes might influence the outcome of the negotiations.”
James-Smith assured that Denmark will seek to find common ground, instead of pushing its agenda when it takes the lead on the file, “otherwise it is never going to end.”
Helen Collis contributed reporting.
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