In just two decades, the European Union has gone from leading global biomedical R&D to being the origin of only 23% of new drugs, while 47% already come from the United States
The new Pharmaceutical Strategy promoted by the European Commission may be an opportunity, if done well, to reinforce investment in innovation and production on the continent
In a meeting on the occasion of the Portuguese presidency of the EU, Farmaindustria proposes to create a High Level Forum, with authorities, the scientific community, patients and industry, to define the measures of the Strategy
Europe’s share of global investment in biomedical research has been declining in recent years, given the greater number of research centers created in other areas, mainly in the United States and more recently in China. This has led to our continent having ceded to the United States the leadership that it held in drug R&D at the end of the last century. And it is not that investment in Europe has not grown, but that the US bet has been even greater. “Between 1990 and 2017, investment in R&D in our continent grew 4.5 times, while in the United States it multiplied by 9. This has led to the fact that the European Union is currently the source of only 23% of new medicines, compared to 47% in the United States, ”said Iciar Sanz de Madrid, director of the International Department of Pharmaindustry, at an informative meeting on the occasion of the Portuguese presidency of the EU organized this Thursday by the Portuguese Embassy in Spain.
Now, the European Commission is promoting a new European Pharmaceutical Strategy, a series of proposals with which Brussels aims to boost the level of competitiveness in biopharmaceutical innovation on the continent and improve aspects such as patient access to medicine. “This Strategy, presented at the end of November and which must be specified and developed throughout this year, must create the right conditions for Europe to once again be the world leader in biomedical innovation and regain ground lost to the United States and Asia. ”, Assured Sanz de Madrid. “However,” he pointed out, “the text presented by the European Commission raises some doubts, since it proposes reducing a series of incentives for R&D that have been key to the launch of innovation in some areas such as orphan drugs. (those that fight rare or infrequent diseases) or pediatric treatments ”.
Farmaindustria sees it necessary for Europe to bet on preserving the stability and predictability of the current European framework of research incentives to attract investment and allow the pharmaceutical industry to continue innovating on our continent. “The pharmaceutical industry has reached out to the European Commission to develop a more agile and competitive European regulatory framework, which does not imply making profound changes to the current legislation, but rather applying the appropriate policies,” he added.
Proposals to improve the lives of patients
In addition to protecting the R&D of medicines, it is also essential that European policies guarantee that patients’ access to treatments is fast, equitable and sustainable, said the director of the International Department of Pharmaindustry. “The pharmaceutical industry is committed to the health and equitable and delay-free access of patients to new treatments. The solution to the problems of access of patients to new treatments requires a joint reflection of all the agents concerned about the current regulatory framework and the causes of non-availability and delays. With this objective, it is necessary to identify regulatory barriers and address the effects of the international price reference system, promoting collaborative solutions that do not endanger the necessary balance between innovation, access and sustainability ”.
This new framework prepared by the European Commission should serve, according to her, to establish general principles that allow a posteriori adaptation of policies, without the need to go to additional legislative reviews. Thus, some of the measures that, according to the European pharmaceutical industry, the Pharmaceutical Strategy should include include stimulating the use of new designs in clinical trials that allow speeding up procedures and authorizations; ensure scientific dialogue early and during drug development; improve the security and transparency of supply chains through the use of data stored in national repositories, or support initiatives for environmental sustainability during the life cycle of pharmaceutical products.
Participation in decision-making
In order to develop this Strategy in the most appropriate way, Farmaindustria proposes the creation of a High Level Forum in which, together with the political authorities, the industry and other agents, such as health professionals, the scientific community and patients, also participate. to define the most appropriate measures. “This forum should serve to jointly identify the causes of current access problems and, based on that analysis, create a model that allows patients to have access to new therapies while ensuring the sustainability of health systems.”
This framework – explained Sanz de Madrid – should make Europe a pole of attraction for investments in biomedical research. “An adequate policy to promote R&D, in addition to the advances that it can achieve for many diseases even without treatment, can contribute to placing Europe in an advantageous position in the global economy and creating new opportunities for employment and growth” .
“Europe is playing a lot with this Strategy,” he stressed. He is critical that the new policy reverse the trend that threatens to leave Europe heavily dependent on the United States and China for pharmaceuticals. Choosing the right policies to address these challenges will be critical to avoid further loss of competitiveness. As we have seen during this pandemic, to face eventual health crises and unmet medical needs, a certain strategic sovereignty of our continent is required, which can only be achieved with a boost to R&D through new incentives adapted to these challenges ”.