Brussels, Frankfurt Every centimeter of leeway has been used to advance health policy as far as possible, said Margaritis Schinas, Vice President of the EU Commission, when he presented proposals for new pharmaceutical laws this Wednesday. In fact, the EU normally only has peripheral responsibility for health issues. But the reforms should have a great benefit for the Europeans: They should get important medicines faster and more reliably and pay even less.
This should be made possible above all by changes to the so-called document protection, which protects new drugs from cheaper imitation drugs. In order for these so-called generics to get onto the market more quickly in the EU, the developers of the original drugs should be given shorter protection for their new drugs. “We want to see prices go down,” Schinas said. Instead, however, there are bonuses for those drugs that are particularly urgently needed.
Most of the industry associations are critical of the project. The European pharmaceutical umbrella organization Efpia and the German association of research-based pharmaceutical companies (VFA) consider the reform proposals to be a “missed opportunity”. Efpia Director General Nathalie Moll expects the overall effect of the package to be that research investments in Europe will continue to decline and increasingly shift to the USA and China.
Wolfgang Große Entrup, Managing Director of the German Chemical Industry Association (VCI), criticizes: “Instead of boosting the innovative power of drug manufacturers, the EU Commission is inhibiting the competitiveness of the European and German pharmaceutical location.” The goal of promoting the supply of new drugs will clearly be missed. “If the protection period is reduced, this discourages companies from continuing to conduct cost-intensive research for new drugs here,” he says.
Even the Federal Association of the Pharmaceutical Industry cannot see any future concept for a competitive industry in the pharmaceutical package of the EU. If you want to reliably ensure the supply of medicines in all EU member states, research, development and production in Europe must meet industry and location-friendly framework conditions, says CEO Hans-Georg Feldmeier.
Longer protection against copycats for medicines imported across the EU
So far, new medicines have been protected from imitators for up to eleven years. In the future, this should generally only be nine years. First of all, this reduces the incentive to develop new drugs. But the companies can get additional protection periods. In particular, if companies sell their medicines in all 27 Member States, they gain an additional two-year protection against counterfeiters.
The EU Commission wants to ensure that medical progress also reaches smaller member states. The market launch there has often not been worthwhile for the company. Of the medicines approved by the European Medicines Agency (EMA) between 2015 and 2017, 104 were available in Germany in 2018, but only 11 in Latvia.
“We are moving to a system where companies can cumulate different incentives,” said an EU official. In the end, market protection is granted that is among the most generous in the world. The USA, for example, offer up to twelve years. According to Commission Vice President Schinas, the EU will continue to have one of the most industry-friendly protection regimes in the world. The system will reward innovation and improve access to medicines.
Generics are drugs that have the same active ingredients as a previously approved drug.
(Photo: dpa)
The goal is a “common single market for medicines,” said the EU official. All Europeans should have access to the latest medicines. There are currently extreme differences between individual Member States as to how quickly new medicines are introduced onto their market. For some it only takes months, others have to wait years.
>> Read here: Pharmaceutical companies criticize Germany as a location
The project of the EU Commission is well received by patient organizations. The European Patients’ Forum said they had been waiting for these reforms for a long time: “We welcome the proposals to strengthen incentives for faster market introduction and early access to medicines for patients.” The industry must use the new opportunities for the benefit of patients.
Faster approval procedures planned
The EU Commission also wants to significantly speed up the approval process. So far, authorization takes up to 400 days, the EU official said. In the future, it should take a maximum of 180 days in the standard procedure and 150 days in the accelerated procedure.
“We want to see prices go down,” Schinas said.
(Photo: imago images/ANE Edition)
The Commission also intends to pre-authorize promising drugs to secure investment in their development. During the pandemic, there had been criticism of how long it took to approve new vaccines. In order to avoid drug shortages like last winter, the EU wants to draw up a list of critical drugs such as painkillers and antibiotics. In the future, pharmaceutical companies will have to notify Ema at an early stage if there is a threat of a shortage of a drug.
While industry welcomes the acceleration of the approval process, the expanded reporting requirements for delivery bottlenecks are criticized as an additional bureaucratic burden. “Unfortunately, welcome administrative simplifications are being nullified by new requirements,” says Hubertus Cranz from the Federal Association of Drug Manufacturers (BAH).
In his opinion, stricter obligations regarding the ability to deliver medicines and the reporting of bottlenecks will not increase security of supply. According to the association, this requires comprehensive solutions and a change in remuneration structures.
>> Read here: How Lauterbach wants to tackle the drug shortages
In order for the Commission’s proposals to become law, the European Parliament and the Member States must agree. The Commission wants to try to accelerate this process so that it is completed before the European elections in spring 2024. Some observers consider this unrealistic.
More: Brussels is planning the biggest pharmaceutical reform in 20 years