During the first half of 2023, all eyes will be on Sweden as the country takes over the presidency of the EU. All signs point to the coming spring being very eventful as many crucial issues are to be addressed. Among other things, there will be a major review of the common European regulatory framework for medicines.
Lotta Liljelund is an expert on EU issues at the industry organisation LIF and public affairs manager at Novartis Sweden. She hopes that questions about life science will be on the agenda in 2023.
“The pharmaceutical industry is important for the Swedish economy as it generates many jobs, large export revenues whilst also financing a lot of research and development. This is also the case at the EU level, where 800 000 people are employed in the sector.”
Major challenges ahead
But both Sweden and the EU are facing major challenges. According to Liljelund, the European pharmaceutical industry is facing increasing global competition, where relative competitiveness is currently being lost as China, Japan and the United States increase their research investments more than Europe does.
“Sweden is also losing relative to these countries, now it is important to catch up,” says Liljelund, who believes that some issues are extra important for the industry.
“IP rights are fundamental for a competitive pharmaceutical industry, and we want to see good framework conditions that enable continued investments in the EU and in Sweden.”
A chance to highlight Sweden as pioneering
The presidency can be an opportunity for Sweden to highlight the importance of collaboration between the private and the public sector when it comes to life science, says Lotta Liljelund.
“In Sweden, we have a life science office that is coordinated by three ministries and collaborates broadly with many players including industry, it is an important part of the Swedish system. I hope we can be a pioneering country when it comes to the collaboration that is needed for complex solutions.”
The common regulatory framework is being reviewed
An important issue will be the review of the European pharmaceutical legislation, where proposals for revision will be presented in 2023. Since 1965, the EU has been responsible for the legislation and marketing of medicines within the EU member states. EU legislation also form the basis for decisions regarding approval of and carrying out of clinical trials. The basis of the common regulatory framework is the objective of protecting public health and ensuring that all citizens in EU countries have access to safe medicines. The current pharmaceutical legislation is 20 years old, and the Union has decided to carry out a thorough review of the regulatory framework. This could have a major impact on the entire industry.
Linda Melkersson, lawyer at LIF, explains that EU legislation is, among other things, crucial for how the European Medicines Agency (EMA) assesses new drugs. Since its establishment in 1995, the EMA has been responsible for the evaluation, supervision and pharmacovigilance of medicinal products.
At present, there is no completed proposal on how the regulations should be changed, but some of the proposals have been leaked to the public.
“The review will mean major changes for the entire industry. The Commission itself has called it the ‘Once in lifetime revision of the pharma legislation’. So, this is a big deal that we’ll be living with for quite sometime.”
The EU has a common pharmaceutical strategy, one of the objectives of which is to increase the availability of medicines throughout the Union. The EU are of the opinion that today access to medicines differs for patients depending on what country they are located in. Strengthening the EU’s competitiveness is also a stated objective.
Seeing risk of conflict between different goals
Linda Melkersson thinks that there is a risk that these goals may conflict with each other.
“In the current legislation, regulatory data protection applies for eight years, which, according to the leaked proposal, is intended to be reduced to six years and for the last two years the regulatory data protection will be conditional upon the company launching its product in all 27 member countries.”
Melkerson believes this is an important issue for the industry.
“Predictability is important for the companies’ work. There can be various reasons for not marketing a product in all countries. The EU has a common system of authorisation, but it is still the national healthcare system that decides which medicines are actually admitted into the system. Conditional regulatory data protection provides poorer conditions for the research industry. Nor will it be good to change EU legislation when the problem exists at national level”.
But Linda Melkersson is positive to the review of the regulations.
“The rules are 20 years old, there is probably a lot to improve. Just think of all the technological developments we have seen in the last two decades.”
Potential to review the future role of the physical patient information leaflet
Another issue that is relevant for the review is the patient information leaflet in paper that today comes with all medicines.
“There we would like to see a gradual transition to a digital leaflet so that everyone has access to the very latest information and to help the environment of course. Under the current rules, you can be forced to withdraw a medicine just because a change has been made to the patient information leaflet. Here you need to work gradually, digital development looks different in the different member states.”
Another issue that is expected to be addressed in the run-up to the review is drug-device combination products, i.e. a combination of technology and drugs.
“There, the regulatory framework is now very complex. We hope that the EMA will be given a clearer mandate to assess products. This is important because 25 per cent of the company’s pipeline consists of products that combine drugs and devices.”
Here, it will also be important to have competent experts on site at the authorities.
“You have to make sure that there are resources and expertise to assess the new products that will be developed.”
Concern mixed with anticipation
Linda Melkersson says that LIF’s member companies are both worried and expectant.
“When it comes to the issue of changing documentation protection, for example, there is concern now. However, the companies are in favour of an updated regulatory framework that is adapted to the new technology.”
The review is a topic that we can look forward to following for some time to come. During the first quarter of 2023, the European Commission will present a proposal, which will then be followed by negotiations in both the Parliament and the Council of Ministers.
“We may have to wait one to two years for a finished regulatory framework,” says Linda Melkersson.