How a more intensive exchange between authorities and companies, additional staff and increased financial resources can accelerate access to medication in the EU.
Two years ago, the European Commission has initiated the largest reform of EU drug law for over two decades. One goal of the revision is to accelerate the access of the patients to medicinal products. The draft provides to streamline official structures and to make regulatory processes more flexible and efficient. To what extent the US admission procedures can serve as a model for this was recently discussed by experts at a pharmig discussion event.
“We are dealing with two completely different approaches,” explains Angelika Joos, Executive Director in the area of Science & Regulatory Policy at MSD in Brussels, right at the beginning of her keynote, in which she deals with how the composition of both authorities and the approval procedures for drugs in the USA and Europe differ. In principle, the approval process in both regions includes several steps, including the submission of a complete application, which contains data on the pharmaceutical quality as well as preclinical and clinical studies. This data is thoroughly checked by the responsible authorities before deciding on admission. However, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) each proceed differently here.
“As a network agency, the EMA works with experts from 30 EEA countries and EU institutions, while the FDA acts as a central authority. The FDA is already in contact with the applicant before the procedure and continues to check the data submitted during the approval process to ensure a continuous evaluation process. The EMA pursues a structured process with so-called ‘Clock Stops’, in which the authority may pause the evaluation of the drug until there are additional information from the applicant, “explains Joos. This procedure influences the total duration of the European processes. In addition, the FDA uses the process of accelerated procedure much more frequently (Break Through), while the EMA has stricter framework conditions for the so -called accelerated procedure (accelerated methods).
“Pharmaceutical research is progressing faster and increasingly producing more complex and innovative products. Their careful review in the sense of the patient’s security requires time, also for the applicants themselves, so that the necessary, arising questions are answered or missing data. In the course of the past 10 years, the companies have therefore increasingly applied for an extension of the clock stop period, so that this in 2022 has been applied for the first time Even longer than the active assessment phase by the authorities themselves. Compared to the United States, we have a much greater coordination effort through the organizational structure of the over 50 European approval authorities and the European drug authority. Günter Waxenecker, MDRA, Management Head of the Ages Medical Market Authority in Austria.
In the further sense, the FDA has 10,000 employees in the pharmaceutical approval area and cannot be compared with the historically grown, decentralized structure in the EU. The latter offers a high exchange of scientific and regulatory expertise and this will be used even more efficiently for admission procedures with the new EU pharmacy network.
As another expert, Pharmig President DI Dr. Bernhard Wittmann participated in the event. He states: “Authorities and industry, we are all in a boat. Today’s EU approval system was established 30 years ago. In our common interest to adapt it to the challenges of today. The draft for the revision of EU drug legislation shows a serious effort to improve the framework conditions for the pharmaceutical industry.” At the same time, according to Wittmann, the requirements for pharmaceutical companies mentioned in the draft, such as the mandatory market availability in all member states, are not useful in the desired sense. In addition, new regulations in Europe would be constantly coming, such as the municipal wastewater guideline or packaging regulations recently. Way, on the other hand, does not fall because of ever decided regulations. In this way, the industry cannot be relieved and in the long run it is very difficult to help make Europe competitive and to give people access to medicinal products.
Beatrix Linke, Country Lead of IQVIA in Austria, explains that it is necessary for faster access, also evaluation and reimbursement processes that take place in the EU after European approval. “A quick approval alone does not ensure that patients are quickly supplied with new drugs,” said Linke. Financing by the cost bearers is a state matter in Europe, which leads to serious differences in access to medicinal products within the 27 member states. “This means that medicines are available in some countries at different times or at all. In Hungary, for example, a product is only possible for reimbursement by the cost bearer if it is already reimbursed in at least three other countries of the European Economic Area, while in Germany the reimbursement for the first seven months is automatically guaranteed, Linke explains.
DI Dr. Stefan Gara, spokesman for science, energy, climate protection, health and digitization of Neos Vienna, emphasized the importance of European competitiveness in the global innovation race in his statement: “In intensive competition with other regions of the world when it comes to bringing new products onto the market. Innovation -friendly framework conditions are required here, because our competitive ability is on the game.”
According to Gara, you are researching in Europe to deepen knowledge. In the United States, it is more about practical application. As a result, the approval process there is significantly more practical on the requirements of innovative developments. Gara: “The United States shows how crucial it is to make innovation processes efficiently and to accelerate. Europe, on the other hand, has a network of excellent research institutions. Now we have to decide which innovation culture we want to promote- and what framework conditions we create for it. Therefore, central reform and legislative proposals must also be subjected to a ‘competitiveness check’.”
About the pharmig: the pharmig is the voluntary advocacy of the Austrian pharmaceutical industry. The association currently has around 120 members (as of April 2025), which cover the medication market for a good 95 percent. Pharmig and their member companies stand for the best possible security of supply with medicinal products in healthcare and ensure social and medical progress through quality and innovation.