Julia Gueter is standing in a room with cell fermenters in the interdisciplinary development center for biotechnology of the pharmaceutical company Boehringer Ingelheim Pharma GmbH & Co. KG.
(Photo: dpa)
Frankfurt The plans for reforming EU pharmaceutical legislation presented by the EU Commission on Wednesday continue to cause criticism in the pharmaceutical industry. Hubertus von Baumbach, President of the European pharmaceutical umbrella organization Efpia and head of the second largest German pharmaceutical company Boehringer Ingelheim, also sees a need for improvement. “Patients in Europe expect not to be left behind when it comes to medical care. The way the proposals are now worded, I see the danger that this will happen in the long term, ”said von Baumbach in an interview with the Handelsblatt.
The focus of the criticism is the planned restriction of the protection of new drugs against cheap imitation drugs. Various industry associations fear that the pharmaceutical industry will lose innovative strength and competitiveness as a result of the reform.
The so-called document protection should be shortened so that the cheaper generics in the EU can be brought onto the market more quickly. It prohibits drug regulatory authorities from accepting applications from generic manufacturers that refer to the original manufacturer’s documents without their consent.
The basic protection is currently eight years. According to EU plans, it should be shortened to six years. To compensate, there is a system of incentives that pharmaceutical companies can use to earn more protection time again. For example, if you introduce a new drug in all 27 member states within two years, you can secure two additional years of protection.
High regulatory effort for approvals
According to von Baumbach, this is practically impossible for a pharmaceutical company to do. “The national systems don’t even allow that,” he says. In its reform, Europe is thinking of a single health market, but the system has 27 national markets. There are countries that wait with market approval until reference countries such as Germany grant approval and set the price. “The pricing process alone in Germany has been going on for a year,” says von Baumbach.
In his opinion, the incentive system of the reform does not work: “To get the carrot of two years of additional protection, we have to jump over 27 sticks,” he says. Pharmaceutical companies have no influence on the time that a national system needs for the approval process.
Chairman of the Board of Management Balance sheet press conference of Boehringer Ingelheim Pharma GmbH & Co. KG
(Photo: IMAGO/sepp spiegl)
In addition, bringing drugs to market in 27 countries requires a lot of regulatory effort and costs a lot of money. “A large pharmaceutical company can perhaps still achieve this, but a small company cannot,” says von Baumbach. He demands that a European drug reform must also take into account the interests of small and medium-sized enterprises.
The planned revision of the EU pharmaceutical law is the biggest reform in 20 years. The aim is not only to improve the supply of medicines, but also to increase the innovative ability and competitiveness of the EU medicines industry.
The plans include accelerating the EU approval process, and the Commission also wants to give promising drugs pre-authorization to secure investment in their development. The European Parliament and the Member States must approve the project.
Europe is falling behind in clinical research
Efpia President von Baumbach is of the opinion that with the reform proposal, responsibility for better drug supply will be passed on to the pharmaceutical industry. “But such projects also need the solidarity of the countries of Europe. We cannot ignore the fact that not all economies in Europe are equally strong,” he says. Where there are no oncological centers, the question arises as to whether a national health system is even able to offer a comparable standard of therapy.
The industry also shares the basic goals of the reform to ensure good, sustainable patient care. According to Baumbach, this also includes access to clinical studies in which innovative drugs are tested.
A Merck employee stands on the assembly line manufacturing a drug.
(Photo: dpa)
“The question is whether we want to continue to allow cancer patients who no longer have treatment options to participate in clinical trials in Europe in the future, or whether we will have to refer them to China and the USA in the future.”
According to data from the Efpia Association, Europe is increasingly being left behind by the USA and China when it comes to clinical research: while spending on research and development in Europe has increased by an average of four percent annually in recent years, it has increased by more than in the USA eight percent and in China by almost 13 percent. Baumbach: “We have already lost in terms of competitiveness and the reform proposals in their current form do not provide any impetus for improvement,” said von Baumbach.
More: EU Commission wants to shorten protection periods for medicines