The EU wants to make more medicines available to European consumers, faster and at less cost. — In the process, we are starting a battle with the pharmaceutical industry.
Draft to overhaul EU pharmaceutical law — copy obtained by POLITICO — The European Commission will strip consumers of the perks currently enjoyed by pharmaceutical companies and cut prices to allow unbranded rivals to enter the market faster..
It proposes to reduce the amount of time pharmaceutical companies have to market drugs without competition. Currently, companies developing branded drugs have 10 years to successfully market new drugs.
The EU wants to shorten that period by two years. This means cheaper medicines will be able to enter the market sooner, and medicines will reach more people.
However, there is an added twist. Under the draft, companies that make medicines available on all EU markets can recoup some (but not all) of that time.
This is because the EU wants to level the inequalities in access to medicines that plague the EU.
At the moment, German patients are getting new drugs 2 years ago, on average, than Polish or Romanian patients. This is because Western European countries have the experience and bureaucracy to lead the complex task of reimbursing new drugs, and drug companies know they get better deals in wealthier countries. The prices quoted there can be used to negotiate with the rest of Europe.
But the divide is getting worse for EU executives looking to build “health unions”.
Consumer and civil society groups have widely welcomed the move. Ansela Santos Quintano, senior health policy officer at the European Consumer Organization (BEUC), said the proposal was “positive” and would give patients faster access to innovative treatments. I was.
Rosa Castro, senior policy manager for the NGO European Public Health Alliance, agrees. “It is important that these incentives are fine-tuned now.”
Clinical Trials and Tribulations
The big pharmaceutical companies see it differently. Europe already claims to lag behind the US and China in the R&D race. Boston, not Berlin, is the perfect place for ambitious biotech start-ups working on cutting-edge gene therapies and more.
Natalie Mohr, executive director of the European Federation of Pharmaceutical Manufacturers’ Associations (EFPIA), a lobby group representing European industry, lashed out at the proposal. She pointed to the widening gap in pharmaceutical research investment between the US and Europe, which widened from her €2 billion 25 years ago to her €25 billion.
“Europe’s reliance on US and Asian innovation is what we see as draft legislation, whether it is a naive idea, blind optimism, or a more conscious decision. No one doubts that this would be very damaging to the competitiveness of innovative companies in Europe, the pharmaceutical industry,” Moll told POLITICO.
That doesn’t mean all hope is lost for Big Pharma.
Nearly two months before the EU legislative proposal officially launches, industry representatives can make one last push to influence the draft. Watchdog Group Corporate Europe Observatory Estimate Brussels has over 290 pharmaceutical lobbyists, making it one of the most influential sectors in the EU.
And big pharmaceutical companies have powerful allies in the capital. Heavyweights like France and Germany have important industries they want to protect. They will get the final say before the legislative text becomes law.
But there are structural forces that mean sooner or later the pharmaceutical industry’s reputation will change.
Given Europe’s aging demographics, healthcare costs are expected to rise relentlessly as the population ages. Drug prices are a big part of that. Taming them will be an important part of the long-term solution. Otherwise, you risk disastrous spending in the long run. As the medical saying goes, “prevention is better than cure.”
