Differences in the availability of modern medicines in the EU: causes and possible solutions
The availability of innovative medicines varies considerably across European countries. In the Czech Republic, 99 out of 168 new modern medicines for the treatment of oncological, rare and many other diseases registered with the European Medicines Agency are available. In terms of the availability of innovative medicines, the Czech Republic is better off than the other V4 countries, while it lags behind some Western European countries such as France, Austria, or Germany.
Although this result is only indicative[1], it illustrates the general differences in the availability of therapeutics across the EU. What is the main cause of delays? What solutions can be found at the Czech and European levels? Will the proposed reform of the European Pharmaceutical Legislation presented by the European Commission at the end of April 2023[2] improve the situation?
These are the main topics addressed by representatives of the European Commission, the European Parliament, the Ministry of Health, the Czech Association for Rare Diseases (ČAVO), VZP and other healthcare partners in May at the AIFP international conference organised in cooperation with the European Federation of Pharmaceutical Companies and Associations (EFPIA) under the auspices of the State Institute for Drug Control (SÚKL).
The current reform of European medicines legislation is one of the most important European health topics of the last 20 years. The new legislation will significantly affect the availability of modern medicines for European patients for many years to come and may weaken or strengthen Europe's position on the global medicines market. Its main objective is to ensure faster and more equal access to modern medicines and eliminate their availability disparities while supporting Euope’s competitiveness in the field of innovations.
Position of the European Commission and the European Parliament
During the conference, Anthony Rodiadis, a representative of the European Commission, presented the Commission's intentions and the difficulties the EU Member States face in accessing modern medicines. The Commission's solution to differential accessibility would be to incentivise market authorization holders to market medicines in all EU member states within two years of their marketing authorisation, through flexible patent protection instruments.
“Today, there is data protection for eight years and market protection for two years. We propose to reduce data protection to six years, whereby for each innovative medicine, protection could be extended, for example, by achieving important public health objectives. If an innovative medicinal product is placed on the market in all Member States of the European Union, it would receive additional two years of protection. For orphan drugs, the protection period would be longer, with nine years of market exclusivity, one year for marketing, one year for unmet medical need and up to two additional years for an additional indication,"
explained Mr. Rodiadis.
Czech MEP Ondřej Knotek then presented the expected development of the package in the European Parliament. He highlighted not only its importance at the level of this European institution but also concerns about its future after the upcoming autumn elections. “The pharmaceutical package is very important for the European Parliament. However, the question is how the new MEPs will treat the text after the elections. It is possible that the debate will return to square one." He also expressed uncertainty about whether the current package will lead to increased investment activity in innovation: "Investors making
investment decisions are not sufficiently protected by the current proposal.“
Analysis of the causes of unavailability
Tim Wilsdon and Hannah Armstrong of the consultancy Charles River Associates presented an analysis focusing on the root causes of the accessibility gap. This confirmed the expected fact: "We are witnessing differences in the affordability of medicines for patients based on differences between European countries in the extent to which they approach the assessment of price and reimbursement of innovative products based on their value to the patient and their environment."
Their analysis revealed ten different factors affecting the situation in EU Member States:
Before the registration of a medicine
- The speed of the regulatory process
- Accessibility of medicines prior to marketing authorization
- Initiation of the process
- The speed of the national timelines and adherence
- Misalignment on evidence requirement
- Misalignment on value and price
- The value assigned to product differentiation and choice
- Insufficient budget to implement decisions
- Diagnosis supporting infrastructure and relevance to patients
- Multiple layers of decision-making processes
All factors are relevant to the Czech Republic, but some are more common than others. Later availability of medicines is influenced, for example, by waiting for the availability of the product in at least three other markets when setting the maximum price, by the course of negotiations on the economic aspects of the entry of innovations, by indication and prescription criteria, and by the course of contractual pricing arrangements with health insurance companies.
According to David Kolář, executive director of AIFP, the main reason for the different availability of modern medicines for patients across Europe is the different healthcare systems in the 27 EU countries.
The view of the innovative pharmaceutical industry
The innovative pharmaceutical industry welcomes the European Commission's initiative and sees it as an opportunity to streamline the environment and processes related to access to medicines for patients. It appreciates several of the partial changes proposed in the package, in particular the simplification of the regulatory framework and the shortening of some deadlines in regulatory procedures.
On the other hand, the industry disagrees with some of the proposals, as it sees them as going against the stated objectives of the reform and posing a risk to maintaining Europe's innovative potential in the field of pharmaceuticals. Clear risks are visible in cutting the regulatory data protection period. Ultimately, it also means a real reduction in the availability of innovative medicines for European, and hence Czech, patients.
Thomas Allvin, the EFPIA representative, pointed out a shortcoming in the current draft package and its practical unfeasibility: "Innovative pharmaceutical companies are ready to apply for inclusion of new medicines in the pricing and reimbursement system in all EU countries within two years of their registration. However, they cannot guarantee actual availability on the markets because this depends on the regulatory processes of individual Member States." He also presented possible solutions to current challenges in healthcare systems, such as the use of new payment models that allow for a comprehensive assessment of the benefits of medicines, while spreading reimbursement over time based on their success.
In his presentation, Matt Slabbert of Bayer stressed that “Enabling faster access to innovative medicines is ultimately about building trust in the science, in the process and most importantly in the people who are all working towards achieving access for patients”.
In conclusion
The event ended with a discussion panel attended by the Deputy Minister of Health, Jakub Dvořáček, Director of SÚKL Irena Storová, Head of the P&R Medicines Department at the General Health Insurance Company Jiří Štěrba, representative of the patient organisation ČAVO René Břečťan and Chairman of the Board of AIFP Pavel Sedláček.
Conference recording
A full recording of the conference, including the panel discussion, can be found on our YouTube channel:
- In English: https://youtu.be/5mxoKKu1pC0
- In Czech: https://youtu.be/Yrxk14uyNn8
[1] Drug availability is also influenced by indication and prescription criteria. These determine which patients and at what stage of treatment can access the medicine and which healthcare professionals, based on their specialty, can prescribe the medicine. These can vary considerably from one EU country to another.
[2] For more information on this issue, see https://aifp.cz/cs/oficialni-vyjadreni-mgr-davida-kolare-vykonneho-re/
