The New Pharma Legislation – A Long-Term Robust Approach

It is worth noting that political decision-makers at present happen to be under pressure to swiftly accomplish the initial reading of the European Union’s ambitious new pharmaceutical legislation before the upcoming European elections in May 2024. It is extremely important for them to ensure that the legislation gets reviewed thoroughly and implemented with the highest precision.

The Science|Business Health, and Life Sciences Day on November 15th centred around the topic of enhancing efficiency as well as incentives for innovation. The idea was to expedite the process when it comes to introducing new medicines and medical therapies to the market. However, the permanent question remains: how can one achieve this goal without playing with patient safety?

The participants from the European Parliament, the European Commission, as well as the Spanish health authority have gone on to express their desire to heighten flexibility in the case of the new EU Pharmaceutical Regulation and Pharmaceutical Directive. These regulations are at present under review by the European Parliament and Council of the European Union. They stressed the significance of this approach, considering that the two new sets of laws are very lengthy and complex, making it highly unlikely for them to be assessed again for another 20 years.

They do not have any intent of becoming a hindrance when it comes to research and innovation, stated Lilia Luchianov, a policy officer in DG Sante who has co-authored the Commission proposals and is also closely monitoring the co-decision process. The package must have the necessary flexibility to accommodate emerging technologies, like AI and new medical devices, as well as innovative platform technologies that integrate pharmaceutical along with other medical advancements. This flexibility should go on to extend to technologies that are in the development stage or, for that matter, have not yet been invented.

Numerous key issues need to be taken care of

A member of the European People’s Party- EPP and one of the lead negotiators in Parliament, Tomislav Sokol, has gone on to highlight the existence of major disparities among various political groups with regards to the concept of innovation sandboxes, which go on to serve as controlled environments where new regulatory approaches can get tested for a limited frame, especially when it is not feasible to come up with innovative products in the existing framework. He adds that the starting point of the EPP is to promote investment by having legal certainty as well as predictability for companies. Apart from this, they aim to introduce modulation as and when necessary, like providing additional incentives for pediatric medicines or even rare diseases. The reason for this is that the market alone does not give out enough incentives for companies so as to invest in developing cures for very rare diseases or new antibiotics.

Head of regulatory affairs for Europe at one of the pharma giants, Janina Dzambazoska, went on to express her delight at the positive outcome of the panel discussion. She emphasized the need for the EU pharmaceutical approval system in order to enhance its speed as well as agility. She added that everybody benefits from treatments and also stressed the importance of prioritizing innovation, making sure of predictability within the system, and also ultimately speeding up the delivery of medicines to patients.

She went on to explain that certain elements of the proposals, such as executing mandatory uniform standards for the design of scientific studies, will prove to have an adverse impact on clinical research in Europe, which would thereby lead to delays in patients accessing the most innovative medicines. She also argued that the EU should aim for higher agility and replace the present sequential reviews with parallel reviews of indications. Moreover, she suggested lessening procedural work and bureaucracy in the post-approval scenario, which would, as a matter of fact, go on to result in faster access to innovative medicinal products.

Besides this, other speakers emphasized the drawbacks of the current system with Sol Ruiz, the head of biologics, biotechnology, and advanced therapies at the Spanish Agency of Medicines and Medical Devices, saying that national regulatory systems are functioning effectively under the present legal framework, but they do encounter certain difficulties, like the most pressing need for experienced personnel.

MEP Sokol went on to express his frustration over the fact that, although the European Medicines Agency- EMA has granted scientific approval to a pharmaceutical product, a formal decision from the European Commission is needed for its approval. In his opinion, in an ideal world, the EMA should have the capacity to fully authorize pharma products without the need for a second step.

But it looks like the idea will have to wait for the forthcoming revision of EU pharmaceutical legislation, as it does not currently have majority support in Parliament or the Council.

The due date for alterations to the two pieces of legislation in the European Parliament has been passed recently. MEPs will now have to dedicate several months to carefully evaluating and adapting the proposed amendments and subsequently looking for political compromises. The Parliament aims to make the first reading on the proposed package prior to the European elections, which will enable the incoming Parliament to have a definitive mandate so as to engage in further negotiations with the Council and Commission. Apparently, these negotiations will take place after the new EU leadership come autumn assumes its role.