The proposed revisions of the European Union’s pharmaceutical legislation are not courageous enough to trigger a substantial change in the policies that regulate the market and research of medicines. This was underlined by Massimo Florio, professor at the University of Milan in the Department of Economics, management and quantitative methods.
Within the Inequalities and Diversity Forum, Florio conceived and promoted the idea of creating a European public infrastructure for the development of vaccines and medicines, the European medicines facility, which however was not included in the text of the position of the European Parliament on the new legislation, voted on 10 April in Brussels. For the Forum, this is a step backwards compared to July 2023, when the proposal found space among the recommendations to the European Commission and Member States in the report on the “lessons” on the Covid-19 pandemic. In the coming months the file will be followed by the new Parliament, after the European elections in June 2024, but for the teacher there are many critical issues contained in the current reform versions of the regulation and directive.
Let’s take a step back. In November 2020, the European Commission presented the Pharmaceutical Strategy for Europe to rewrite the current regulatory framework. After a series of public consultations and meetings between companies and regulatory authorities, a package of reforms was published in April 2023 with the aim, declared by the Commission, of making “medicines more accessible and convenient, while supporting competitiveness and the attractiveness of the EU pharmaceutical industry, with standard higher environmental standards”. And which includes proposals for a new directive and a new European regulation, as well as changes to the legislation on medicines for pediatric use and for rare diseases.
The final text approved by Parliament last April 10 manages to limit the influence of the pharmaceutical industry, especially compared to its initial ambitions, but according to Florio those made to the current legislation are only tweaks and overall this reform is “anything but overwhelming compared to expectations.”
In fact, it contains a series of proposals that should incentivize companies to enter the European market, including a protection mechanism: a period lasting seven and a half years during which companies cannot have access to data relating to an authorized medicine and studied by another industry to possibly start other studies.
“Basically, companies communicate to the European Medicines Agency the data collected from patients during studies to allow it to evaluate the marketing authorization of the product, but for a certain period these data must not be made public -explains Florio-. Consequently, another company that wants to access them to study them and possibly propose something new cannot do so. He can’t use them. And so it cannot bring about innovation as long as the protection lasts.”
Furthermore, if the medicinal product produced meets a series of criteria (for example linked to therapeutic needs not yet satisfied, if a significant share of research and development takes place in European Union countries) companies could benefit from an extension of protection period. Which, according to parliamentarians, overall should not exceed a maximum period of eight and a half years.
An additional two years could then be added thanks to the market protection mechanism, which would prevent other generic, hybrid or biosimilar drugs from being sold and therefore from competing with a company’s product. This period of time can also be extended by a further twelve months if the drug were to obtain marketing authorization for a different therapeutic indication, or to possibly treat a symptom or disease different from that indicated in the authorization phase.
The so-called orphan drugs, developed to treat rare diseases (which affect no more than one case in every two thousand people), could instead benefit from market exclusivity for a maximum of 11 years if they were to respond to a “high unmet medical need”. A higher threshold than that proposed by the Commission which, initially, had a variable duration of ten, nine or five years, based on the type of medicine.
“Pharmaceutical companies argue that this is a fundamental incentive for them to innovate in some fields, because they are willing to enter a market and invest in trials as long as they have reduced competition. Which translates into exclusive earnings -explains Florio-. If for a rare disease there are one hundred thousand patients in the world, companies invest in research counting on receiving a return from that specific number of people. Therefore, if a molecule capable of solving that problem were developed during the exclusivity period, it could not be produced. It could be patented, but not put on the market.”
According to the European Pharmaceutical Strategy, these incentives, combined with existing intellectual property rights (drug patents), will allow Europe to be an attractive hub for investment and innovation. For Florio, however, these are “anti-competitive and anti-innovation” mechanisms, which also include the voucher transferable data exclusivity, a tool designed to stimulate research and development of antibiotics and priority antimicrobials, necessary to combat the spread of the phenomenon of antibiotic resistance.
The voucher grants the company developing a priority antibiotic an additional year of regulatory data protection, which can be used for any other product included in the company’s portfolio, which is therefore transferable. The Commission’s text also provides for the hypothesis of the sale of voucher between companies.
A principle that had been highly criticized by three experts in health economics – Simona Gamba, from the University of Milan, Laura Magazzini, from the Sant’Anna high school in Pisa, Paolo Pertile, from the University of Verona – in the study carried out for account of the Panel for the future of science and technology (Stoa), the scientific committee that works in support of the European Parliament.
“This is the famous study published on the Parliament website, then canceled due to pressure from the industries and subsequently republished – recalls Florio -. This analysis demolished the concept of voucher transferable because it warned against the risk that the data protection obtained could be transferred to other much more remunerative drugs, given that the choice of where to transfer the ‘voucher’ is at the discretion of the industries. The consequences may be market distortions caused by the increase in the value and price of those drugs.”
For Florio these are mechanisms for creating a legal monopoly: “Substantially these proposals acknowledge that companies have their own priorities and decide what to do. Therefore, if politics wants to push them to do something that is not convenient from an economic point of view, it must provide incentives. And since state budgets do not allow the provision of financing, as is done in the United States, all that remains is to resort to market incentives.”
The legislative reform proposed by the European Parliament also addresses the environmental issue linked to the production of medicines, requiring companies to submit a risk assessment on the matter when applying for a marketing authorisation. It also plans to give greater independence to the Authority for Health Emergency Preparedness and Response (Hera), established under the legal personality of the European Center for Disease Prevention and Control (ECDC). It would thus be “responsible for the creation, coordination and implementation of the European long-term biomedical research portfolio and the program for the development of medical countermeasures against current and emerging threats to public health, as well as for the production, procurement, storage and the distribution capacity of medical countermeasures and other priority medical products in the EU”.
For Florio, this is a compromise with respect to the public biomedical infrastructure proposal developed within the Inequalities and Diversity Forum, designed to have much broader operational intervention capabilities, with a broader mission in the field of drug research and development. The support given by 156 MEPs who tried to relaunch it during the plenary of the European Parliament also leaves an open space: “The game is not over – concludes the teacher -. If the idea of some researchers has been adopted by a significant number of deputies, among other things from various parties and different countries, it means that it is starting to make headway. Within the next European Parliament there will also be a commission on the topic of health, which currently does not exist: the topic, in fact, is followed by the Committee on the Environment, Public Health and Food Safety (Envi). I expect that health issues will be very important, but we will see who the research and health commissioners designated by the next European Parliament will be.”
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