2023-04-26 12:48:07
Security of supply, more drug research and faster, comprehensive access to drugs are of central importance, but they need incentives and not restrictions.
“Companies will direct their focus to where they find favorable framework conditions for their research, market access and production. The USA is already a pioneer in many areas, and China is catching up with great strides. Europe, on the other hand, seems to be doing everything it can to make it as easy as possible for these two regions to press ahead and leave ‘good old Europe’ behind or make us even more dependent on them.
Mag. Alexander Herzog, Secretary General of PHARMIG
Vienna (OTS) – Revised to advance drug research and ensure access to both new and proven medicines: The EU legal framework “Pharmaceutical Legislation” has been revised for the first time in 20 years. The proposed changes that the European Commission has drawn up and that are now available for public comment only do justice to this goal to a limited extent. Instead of providing research and other incentives for more medicines, faster and broader access to medicines and strengthening Europe’s competitiveness, the draft regulations do the opposite. They force the pharmaceutical industry into a corset of restrictions and tightening. As a result, negative effects on Europe as a research and production location and also on the supply of pharmaceuticals are to be feared.
The separate areas of market access and incentives are interwoven in the text presented in such a way that requirements for companies cannot be implemented and it is made unattractive for companies to take the high risk that the development of new medicines entails in Europe. Alexander Herzog, Secretary General of PHARMIG: “Companies will direct their focus to where they find favorable framework conditions for their research, market access and production. The USA is already a pioneer in many areas, and China is catching up with great strides. Europe, on the other hand, seems to be doing everything it can to make it as easy as possible for these two regions to press ahead and leave ‘good old Europe’ behind or make us even more dependent on them.”
The planned reduction in data protection periods or their link to new criteria hardly promotes the spirit of innovation. As far as the specifications for market entry are concerned, it is not solely within a company’s sphere of influence whether a product can be made available in all EU countries within a certain period of time. Herzog: “We have umpteen different healthcare systems in Europe. When and where a company can bring its products onto the market depends on a number of factors that can only be influenced to a limited extent by the company itself. Here the companies are being pushed into a responsibility that they cannot meet at all.”
According to Herzog, the goals of the EU drug strategy should be supported 100 percent, but the way there should not be lined with hurdles or pitfalls. “Unfortunately, that is exactly what is being done with the submitted draft. All in all, this is not a promising European policy,” said Herzog.
About PHARMIG: PHARMIG is the voluntary interest group of the Austrian pharmaceutical industry. The association currently has around 120 members (as of April 2023), who cover a good 95 percent of the drug market. PHARMIG and its member companies stand for the best possible security of supply with medicines in the healthcare sector and ensure social and medical progress through quality and innovation.
Questions & contact:
PHARMIG – Association of the Austrian Pharmaceutical Industry
Peter Richter, BA MA MBA
Head of Communications & PR
+43 664 8860 5264
peter.richter@pharmig.at
www.pharmig.at
1682513320
#Pharmaceutical #legal #framework #Europe #left
