With a large package for the revision of the previous EU pharmaceutical laws, the EU Commission wants to take action against the fact that many newly approved drugs are far from being available everywhere in the EU. "When it comes to access to medicines, there must be no first- and second-class citizens in the EU," Health Commissioner Stella Kyriakides said in Brussels on Wednesday. The EU laws, which have been in force for 20 years, would have to be fundamentally revised. What is needed is a "single market for medicines". The pharmaceutical package is the last but most important step towards the EU Health Union, which has been pushed forward since the Covid pandemic.

Werner Mussler

Economic correspondent in Brussels.

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When it comes to health policy, the Commission is struggling with the fact that, in principle, it lacks competence. However, she sees the pandemic, in which she has occasionally been accused of inaction, as an encouragement to take her own initiatives. The new legislative proposal does not change the competence of the member states in health policy, according to the authority. "But the pandemic has shown that many things work better when we work closely together." With the initiative for a single market for medicines, the Commission is aiming for framework laws that apply independently of national competences.

Kyriakides pointed out that around 90 percent of the medicines approved in the EU are available in the Western and large member states. In eastern and small states, the figure is sometimes only 10 percent. The second key figure for the large differences is how long it takes for a drug to be available in pharmacies after it has been approved by the European Medicines Agency (EMA). According to the Commission, this takes about four months in Germany and more than two years in Poland, Romania or Bulgaria. She wants to level out these differences through new "incentives" for the pharmaceutical industry, Kyriakides said.

Better protection for innovation for new medicines

These "incentives" consist of improved innovation protection for novel medicines, additional requirements and less bureaucracy during authorisation. For example, the maximum possible term of protection is to be increased from eleven to twelve years, but at the same time made dependent on more criteria such as the condition that the respective medicines are sold throughout the EU. The so-called market exclusivity is to be reduced from eight to six years. In addition, as before, there are two years in which generic drug manufacturers can apply for approval of their products but not yet bring them to market. A further three years of protection are to be made dependent on whether manufacturers commit to complying with the Commission's targets.

This does not affect the competitiveness of the industry in Europe, said the Commissioner, referring to the sometimes sharp criticism from the pharmaceutical industry before the publication of the proposal. To make things easier for companies, it is planned to shorten the average testing time in the EMA from the current 400 to around 180 days.
The Commission also wants to ensure that there are no more shortages of medicines due to gaps in supply chains, such as during the pandemic or as a result of the Ukraine war. Here, of course, the EU's hands are tied. The authority is therefore proposing increased monitoring of emerging shortages by the EMA, an EU list of "critical medicines", especially antibiotics, as well as more "coordination powers" for the Commission and the EMA. In order to make medicines more affordable – price regulation is also a national responsibility – the Commission wants to make generic medicines immediately available everywhere in the EU as soon as the innovation protection for a medicine has expired.

Criticism from the industry

In the industry, the Brussels initiative is mainly met with criticism. The Federal Association of Pharmaceutical Manufacturers (BAH) spoke of "a lot of shadow and little light". Welcome, facilitations would be nullified by new requirements. The Federal Association of the Pharmaceutical Industry (BPI) sees Germany as a pharmaceutical location weakened in its innovative strength and competitiveness, because the EU requirements burden medium-sized companies in particular with new bureaucratic burdens.
Kyriakides also announced a new initiative against antibiotic resistance.

This "silent pandemic" costs the lives of 35,000 people in the EU every year, the Commissioner lamented. The main reason, she said, was that the pharmaceutical industry had no incentives to invest in new products that were not yet resistant. The Commission wants to reduce antibiotic consumption by 2030 percent by 20. Furthermore, at least 65 percent of antibiotics should come from a product group that is less susceptible to resistance.