2023-04-26 06:54:19
The EU Commission wants to tackle bottlenecks in the supply of medicines and high prices for medicines. To this end, the Brussels authority will present a reform proposal for pharmaceutical legislation in the European Union on Wednesday. This had been postponed several times due to pressure from the pharmaceutical industry.
The idea came regarding during the Covid-19 pandemic, when the EU ensured that the 27 governments acted together. The package was originally announced for mid-March. Now it is likely to be the most far-reaching reform in two decades. Current legislation dates from the early 2000s.
EU Health Commissioner Stella Kyriakides recently said that a system “is needed that can keep pace with scientific and technological progress and ensure the availability, access and affordability of medicines at all times”.
➤ Read more: Shortage of medicines: German price increase “lack of solidarity”
Acting together
The Commission wants to ensure that medicines are launched simultaneously in all 27 EU countries in the future. At the same time, Ursula von der Leyen’s authority wants to present recommendations once morest antibiotic resistance. According to estimates by the EU health authority ECDC, they are responsible for the deaths of more than 35,000 people in the EU every year. According to the World Health Organization (WHO), 1.3 million people worldwide die from it every year.
As the Handelsblatt reported, antibiotics are to be used more cautiously in the future and warnings are to be placed prominently on the packs. Each country should also adopt a national action plan on how to limit the use of antibiotics. On the other hand, the development of new antibiotics in the EU should be promoted. Anyone who develops a new antibiotic should in future receive an additional year of market protection for another product.
Great skepticism
According to EU Health Commissioner Kyriakides, the reform should also include several measures to combat drug shortages, such as prevention plans and timely notifications from manufacturers. Another aim is to make medicines more accessible to all EU citizens.
One way to make this possible is to reduce market exclusivity, i.e. protect original drugs from cheaper copycat drugs, so-called generics. This should give the pharmaceutical industry incentives to do business with less lucrative EU countries, because there is currently a major imbalance in the availability of new medicines in the EU. Smaller states and those with weaker economic power are worse off than large, wealthy states.
➤ Read more: Children’s medication: “Never seen such a dramatic bottleneck”
There is great skepticism regarding the presentation of the reform on Wednesday. The European Consumers’ Association would welcome weaker protective rights. However, the pharmaceutical industry is once morest it, as this would make Europe less attractive as a research location. As a result, patient care in Europe would also deteriorate. So far, manufacturers have generally had ten years of protection once morest cheaper imitators. An additional year of market protection is added when a new disease to be treated is added to the initial approval.
According to the first draft of the reform, which became known in January, the protection period should be reduced from the normal ten years to a maximum of eight years if the company does not launch its innovative drug in all 27 member states at the same time. According to that Handelsblatt there are no specific figures in this regard in the current draft. They should be announced on Wednesday.
Germany fights back
As the Financial Times reported, Germany and several smaller member states have also resisted the reform of EU pharmaceutical legislation at the last minute. Berlin warned that it would damage investments in the pharmaceutical industry.
➤ Read more: Why Europe produces far too little medicine
A number of other measures were reported in advance. The news agency Archyde.com reported at the beginning of April regarding a draft of the reform, according to which manufacturers might be obliged to disclose the costs for research and development as well as the public funds they have received for a new drug when they apply for approval.
Consumer groups accuse drug companies of exaggerating their costs to justify high drug prices. They therefore welcome the proposal.
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