Following competitiveness concerns from industry over the EU’s pharmaceutical legislation, Austria and Germany added fuel to the fire by bringing the topic to EU ministers in the Competitiveness Council on Monday (25 September).
Usually, the revision of the pharmaceutical legislation is discussed by health ministers in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO).
However following fuss from industry, Austria and Germany urged the Spanish and upcoming Belgian presidency to include the matter in the Competitiveness Council (COMPET).
Martin Kocher, Austrian federal minister for labour and economics, maintained that Europe’s pharmaceutical industry is still in a good position. Therefore, he said, “It is all the more important that the EU pharmaceutical package does not set any measures that hamper innovation and investment and create legal uncertainty that strategically weakens us as a business location, especially in these difficult times regarding competitiveness.”
The minister then called for a “clear, predictable and globally competitive legal framework that actively promotes innovation, guarantees appropriate protection periods for the European pharmaceutical market and thus makes investment more attractive”.
Specifically, he called the proposed reduction of regulatory protection from 10 to eight years an example of a hurdle, which should be discussed in more detail and with “the sectors concerned”.
State Secretary at the Federal Ministry for Economic Affairs and Climate Action of Germany, Sven Giegold, agreed, warning that there is “no time for naivety” and that “we have seen in other sectors what happens when we are late”.
As soon as the European Commission presented the revision of the EU pharmaceutical legislation on 26 April, the EU’s pharmaceutical industry expressed its dissatisfaction.
The revision of the EU’s pharmaceutical legislation aims to revamp the bloc’s regulatory framework, unlocking timely and equitable access to safe and effective medicines for all EU citizens while at the same time boosting the attractiveness of the EU pharmaceutical industry.
The specific proposal to reduce the regulatory protection also comes with the suggestion to award companies two extra years of protection if their new medicines are launched in all member states within two years to lower inequality and boost access to new medicines.
While patient and consumer organisations were generally happy with this, the industry warned that the revision would not “support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry” as advertised, but rather make companies invest and innovate elsewhere.
Speaking to the ministers, EU Health Commissioner Stella Kyriakides argued that the value of pharmaceutical innovation is that it benefits patients and that the revision is about striking a balance between incentives for innovation and patient needs.
She also highlighted a number of the proposal’s benefits for the industry.
“When we have a leaner regulatory environment for investment, when we have simplified and faster marketing authorisation procedures, when we have stronger support for promising medicines and better use of data, this will attract more innovation and benefit the EU industry,” Kyriakides said, adding that “we could save up to EUR300 million a year through these administrative changes”.
While there was no doubt about the importance of the topic, countries like Malta, Estonia and Bulgaria argued that this should continue to be discussed among health ministers, rather than having a second forum for discussion.
“We have our doubts about the duplication of discussions in the formats of the council because we need to have a common position on these extremely sensitive topics. For us, it is very important to find a fair and balanced approach to ensure effective, safe, affordable medicines for the patients,” said Ivaylo Shotev, Bulgarian deputy minister for economic affairs and industry.
Marten Kokk, the Estonian deputy permanent representative, also argued that he was not convinced of the risk that pharmaceutical companies would take their business outside the EU.
“The proposed modulation of the regulatory protection period does not reduce the protection compared to other regions,” Kokk said.
“On the contrary, the current EU system is more generous than the other regions in terms of regulatory protection, and we are not convinced by the argument that the possible investments will be taken out of the EU. And even if that would be true, it would rather be caused by other circumstances such as research and development subsidies or tax measures,” said Kokk.
[Edited by Giedr? Peseckyt?/Nathalie Weatherald]
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