Protecting Innovation in Europe

Is the regulatory framework in Europe deterring investment in the region? A revamp of the EU’s pharma legislation has raised alarm bells in the industry. The legislation was developed to improve security of supply, support innovation, and improve access to reasonably priced medicines, but some stakeholders believe it could have the opposite effect, particularly when it comes to attracting more pharmaceutical investment to the region and getting more innovative medicines to Europeans. We speak with Claus Zieler, Chief Commercial Officer at Astellas and a member of the board of EFPIA, to learn more about Europe’s access to medicine problem.

What are the problems with access to medicine in Europe?
 

The EMA regulates the approval of medicines in the EU, but there is no one agency that regulates reimbursement. Without reimbursement, the majority of a population will not have access to the medicine. There are 27 member states in the EU, which means 27 national health systems and 27 authorities that govern reimbursement criteria; in some countries, such as Spain and Italy, reimbursement even goes down to a regional level.

If you look at the WAIT index in Europe – which shows how long it takes, on average, for a medicine to go from the moment of approval to reimbursement – it is around 500 days. This is slower than other large markets, such as the US, Japan, or China. The problem in Europe is the fragmentation. Each national authority in Europe has its own criteria for reimbursement, with demands for different data. For example, a company will need different datasets to satisfy reimbursement in Germany, France, and so on. It is a huge burden for a pharmaceutical company to do this and it is also very time intensive – and the patient is the one who pays the ultimate price because they are not receiving the best treatments in a timely manner.

How does the regulatory burden in Europe affect investment in the region?
 

Europe used to be competitive in clinical trials, but this has changed dramatically in the last 20 years. Many trials are shifting to the US or China because of a perceived regulatory burden in Europe. Companies are right to ask: why should I perform this research or development in Europe if Europe doesn't give me access to a database, or makes it very slow for me to start a trial? Every hurdle is a deterrent from investment. Europe used to be pretty much on par with the US in terms of investment in R&D in the healthcare industry, but a tremendous gap has now opened up.

How should policymakers respond?
 

I want to appeal to policymakers, parliamentarians, governments, and Ursula Von der Leyen (European Commission President) to think about the competitiveness of Europe in the context of what I have just described. I was pleased to hear that Ursula Von de Leyen argued that competitiveness needs to be a priority in a recent speech in front of the European Parliament. I absolutely agree with her, but the devil will be in the details. It is great to see a will to be competitive, but when I look at the EU pharmaceutical legislation that was tabled last year and voted upon by the parliament in April 2024, I am not quite sure that it makes the cut... Rather than increasing incentives such as the regulatory protection for new medicines in Europe, the legislation will actually decrease them.

I think there is work to do to translate the competitiveness agenda into practice and into legislation that will have real, tangible benefits in bringing R&D investment back to Europe. We have fantastic scientists and knowhow in Europe, but we also need the right environment to get investment to the continent.

What are the main concerns with the EU’s pharmaceutical legislation?
 

One of the biggest cornerstones of the legislation is regulatory data protection to prevent generic or biosimilar competitors launching for a set amount of time. It takes, on average, 10 years to do trials on a new molecule or treatment. The minute a company gives its datasets to an authority for evaluation, the authority guarantees that the dataset is protected for eight years. The legislation wants to reduce this time, but given that it takes, on average, 10 years to do the trials on a new molecule, many companies are unhappy about a reduction in the protection period. It could make the European market less attractive for investment and the launch of new medicines – which runs counter to the competitiveness agenda that Ursula Von de Leyon has formulated.

The legislation has been voted on by the European Parliament and is now with member states to recommend amendments. I strongly urge member states to consider extending the protection period rather than cutting it.

Another regulatory issue in Europe is simply how long it takes the EMA to evaluate a dossier – roughly twice the amount of time that it takes the FDA. The more you can shorten review periods from authorities on approval and reimbursement, the more attractive that area will be to launching a new medicine.

It’s all a question of how much burden you place on an industry and what incentives are offered. If this is unbalanced, as I feel it is today, then it will drive investment away from Europe.

How is EFPIA getting involved?
 

EFPIA represents the industry. We offer our research, know-how, and facts. There are some very good data points that EFPIA has gathered, including studies that have been commissioned to evaluate parts of the pharmaceutical legislation. We’ve approached the European Commission and its health department to discuss the matter, as well as governments in member states. I myself have been in touch with ministers from the Irish government – not only as part of EFPIA but also because Astellas has invested in a manufacturing site there. We’ve had some very constructive conversations about what it takes to encourage investment.

If we can reduce the regulatory burden, shorten timelines, and make access more attractive, we will likely see more investment flowing into clinical trials and R&D initiatives in Europe. Many diseases can be treated with generic medicines, but for some diseases we do not have good medicines available in Europe. Across Europe, healthcare systems and governments say that they want innovation to improve patients' lives and to treat diseases with a high unmet medical need, but they need to back this up with the right actions.

There are governments in some emerging countries that are only interested in generics; if patients want other medicines then they need to pay privately. I’ve never heard that in Europe but we need to walk the talk. If governments and policymakers say they want innovation, they also need to think about the environment for innovation and incentives.

Europe struggles in that it is not a positive environment for innovation, but governments are also not willing to tell their populations that they will not have access to innovative medicines. It's a very unfortunate position both for patients and for industry.

What is your ideal future for the regulatory landscape in Europe?
 

We need a better solution to access than we have today. It should be based on an intense dialogue between the European Commission and the industry about what is hampering access. There are highly intelligent people on both sides; if we join forces and have an open, constructive discussion based on trust rather than ideology, then we will find solutions that suit both patients and member states. Where there’s a will, there’s a way.

I’m really proud to be part of an industry that is so heavily driven by innovation. During the COVID-19 pandemic, the industry demonstrated how it could help billions of patients. Policymakers need to believe and trust in the innovative power of the industry and work with us to solve the access hurdles so that we can bring even more innovations to patients.