2023-04-27 21:27:11
The European regulation reform around the pharmaceutical industry has unleashed uncertainties in the sector. The proposal to reduce the protection period for new medicines by two years, but with the possibility of extending that patent period if the product is marketed in all the countries of the bloc or is highly innovative, raises concerns and entails financial rethinking for laboratories. Brussels defends the need to review a legislation which is now 20 years old and adapting it to the lessons learned after complex situations such as the coronavirus pandemic or the shortage of pediatric medicines last winter in several EU countries. Paradoxically, the ultra-rapid development of covid vaccines has shown that long drug development periods can be shortened and that, consequently, drug patent protection periods can be shortened.
For the pharmaceutical employers, “although the proposal contains several improvements in the regulatory framework, the weakening of the incentive system and increasing obligations of laboratories in all areas risk further eroding the foundations of the innovative industry in Europe, instead of strengthening them,” he said. Juan Yermo, CEO of Farmaindustria. The criticism goes further and puts on the table that the restrictions raised “represent another barrier to patient access to innovative treatments.”
The reform – which still has to be negotiated by the Twenty-seven and the European Parliament based on the Brussels proposal – also includes new requirements for national authorities to reinforce surveillance against the risk of medicine shortages and strengthens the coordinating role of the Agency European Medicines (EMA). For example, companies must notify in advance the shortage or withdrawal of medicines and they will have to design their own prevention plans to deal with the lack of supply.
The problems in the supply of medicines have entered a stage of great lack of control, without it having been possible to determine the culprits of the situation. Laboratories blame the problems of supplying medicines to pharmacies on the difficulties to legalize sudden changes in packaging or presentations, which encourage the blocking of the supply rather than the approval of the necessary changes in case of difficulties in supplying raw materials. The consequence is that the phenomenon of parallel imports o to export of medicines to more profitable markets.
Brussels also wants that before the end of the year there is a list at the community level of “critical” medicines and that work is done to assess the vulnerabilities of the supply chain and recommendations are identified to correct deficiencies. In this sense, the Commission may impose legally binding measures to strengthen the security of supply of specific essential medicines.
The Federation of Pharmaceutical Distributors (Fedifar) lacks in the European legislative proposal a specific and differentiated regulation for the distribution of the complete range, whose raison d’être is to make available to all pharmacies all medicines and health products on the market to thus ensure adequate access for all citizens to their treatments. For the employers of the distributors, the drug supply chain is increasingly complex, however, only full-range pharmaceutical distribution (not specialized in types of product) is capable of guaranteeing that any citizen, wherever they reside, has immediate access to the medicines and health products you need. “For this reason, we understand that it must have a differentiated consideration in the new legislation,” says the president of Fedifar, Matilde Sánchez Reyes.
Data Protection
One of the measures included in the European text is the reduction of regulatory data protection from 8 to 6 years: “This type of limitation on regulatory incentives has the effect of reducing the competitiveness of Europe and investment in R&D of new medicines in the face of push from other regions”, says Farmaindustria. The warning from the laboratories comes at a time when Europe is losing weight in investment in research, compared to the US and China. The current pharmaceutical sector is torn between the American and Asian power, and the productive capacity of India in the field of active ingredients. Currently, only 22% of new treatments originate in Europe, while 47% come from the United States. The great European potential comes from its high capacity in clinical trials, especially in the case of Spain.
patent protection
Another of the keys to the proposed reform points to the reduction from ten to eight years of the standard period of protection for new medicines, although an “incentive” system is included so that pharmaceutical companies could earn up to a maximum of four years if they meet additional criteria that are marketed in all EU countries, address unmet medical needs, undergo comparative clinical trials, or develop a new therapeutic indication.
The Health Commissioner, Stella Kyriakides, has considered “unacceptable” the gap by which Europeans from large countries have access to 90% of new medicines while in smaller countries and in the East this percentage is barely one 10%”. For this reason, the Commission has presented a series of proposals to streamline and simplify the authorization processes for medicines and to move towards a system that offers “accessible and affordable” medicines, although community services stress that the policy of Prices are the exclusive responsibility of national governments and that from Brussels they focus on other initiatives that may have an impact on cheaper medicines. The pharmaceutical employers consider that “in order to provide a solution to the differences in access, all interested parties need to and jointly address the cause or origin of access barriers through effective measures at the national level and not resort to European legislative intervention that, far from solving delays and inequities in access in national markets, erodes incentives to attract investment and ensure that innovation is generated in Europe”.
Another of the concerns of community services is the way in which innovation in the development of new antimicrobials is discouraged by awareness of the need to restrict their use to prevent the further growth of antimicrobial resistance (AMR). The risk of this “market failure” is that many investors are no longer interested in antimicrobial development and thus, without public intervention, there is a risk that new drugs capable of fighting antimicrobial-resistant microorganisms will no longer appear. multiple drugs. For this reason, Brussels proposes a system of “transferable data exclusivity bonuses” to the developers of new revolutionary antimicrobials; some bonds that will give one more year of protection over the standard framework and that the researchers themselves can use or sell to others, always under strict conditions and limited to a maximum of ten in 15 years.
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