Farmaindustria assures that the revision of the European pharmaceutical legislation “puts the future of the industry at risk”
In the opinion of the employers’ association, it “represents yet another barrier to patient access to innovative treatments”
Source: espaciosanitario.com
Following the proposed revision of the European pharmaceutical legislation presented the day before by the European Commission, Farmaindustria has indicated, this Thursday, April 27, that this “puts the future of the industry at risk and represents yet another barrier to patient access to innovative treatments”.
According to the employers’ association, the European Federation of the Pharmaceutical Industry (Efpia), to which it belongs, “had supported the objectives of the Pharmaceutical Strategy of the European Union (EU), which sought to provide faster and fairer access to medicines, avoid and mitigate drug shortages and ensure that Europe can be a world leader in medical innovation”.
“However, the impact of the policies set out in this European Commission review weakens incentives for investment in innovation and thus hinders the development of new medicines in Europe,” regrets Farmaindustria CEO Juan Yermo, who adds that, “although the proposal contains several improvements in the regulatory framework and boosts research into new treatments for the fight against antimicrobial resistance, it contains a series of measures that weaken the incentive system and further erode the foundations of the innovative industry in Europe, instead of strengthening them”.
In this regard, Juan Yermo refers to one of these initiatives, the reduction of regulatory data protection (RDP) from eight to six years. “These types of limitations on industrial property have the effect of reducing Europe’s competitiveness in R&D investment in new drugs in the face of the drive of other regions,” he stresses.
Europe is losing weight in R&D investment
“All this in a context in which Europe has been losing weight in R&D investment in new drugs,” continues Yermo, who adds that “investment in research and development of new drugs is shifting to the United States and China, which, in the last 20 years, have increased their commitment in this area to the detriment of Europe.”
Thus, the director general of Farmaindustria explains that “only 22 percent of new treatments originate in Europe, while 47 percent come from the United States”. “This loss of European competitiveness with respect to other markets that have shown greater growth has a direct implication for citizens, as they are exposed to less access to new drugs or the possibility of participating in innovative clinical trials,” he assures.
“Another of the measures penalizes innovation when the drug is not available in all EU markets during the first two years after the marketing authorization is granted,” continues the employers’ association, which believes that this approach “is erroneous in its basis and is an impossible objective for pharmaceutical companies to achieve”.
In Yermo’s opinion, “in order to provide a solution to the differences in access, it is necessary for all stakeholders to jointly identify and address the cause or origin of the barriers to access through effective measures at the national level and not to resort to European legislative intervention which, far from resolving the delays and inequities in access in national markets, erodes the incentives to attract investment and ensure that innovation is generated in Europe”.
Efpia’s position
“Although the proposed pharmaceutical legislation was designed to improve European competitiveness, the policies contained in the proposed legislation, as currently drafted, erode incentives for investment in biopharmaceutical innovation, restricting science, research and development of new medicines in the EU and thereby jeopardizing Europe’s competitiveness,” says Efpia President Hubertus von Baumbach.
In addition, the CEO of the EU employers’ association, Nathalie Moll, says that the European pharmaceutical industry is now committed to working with members of the European Parliament and Council, as well as other stakeholders “to ensure that the proposed revision of pharmaceutical and industrial property legislation meets the needs of patients, healthcare systems and Member States without undermining the current innovation ecosystem in Europe”.
“If no changes are made to the proposed legislation, the legacy of the European Commission will be an EU that consumes biopharmaceutical innovation researched and developed in other regions and whose patients have delayed access to new medicines,” says Nathalie Moll. The first of these bodies has opened a period of eight weeks, which expires on Wednesday, June 21, for the agents concerned to send in their positions, “comments that will be compiled, summarized and sent to the European Parliament and the Council of the EU so that both institutions can take them into account,” concludes Farmaindustria.
