What have been the key health achievements of the EU since May 2014?

A.B “Since May 2014, many projects have been completed and others are underway. With the set-up of 24 European Reference Networks (ERN), the European Commission and the Member States offer patients with rare, low prevalence and complex diseases better access to diagnosis and care thanks to health experts from all European countries.

Moreover, European citizens are beginning to benefit from the cross-border exchange of electronic health records. The service is being gradually introduced and by 2021, the pharmacists of 22 EU countries will have electronic access to the prescriptions of patients coming from other EU countries. Furthermore, physicians will have access to the medical records of patients from other European countries.

We have worked on the implementation of a system for authenticating medicines and thus combating falsified medicines. The system has been active since February 2019. We have set up an action plan for innovative medicines containing many measures aiming at supporting early access to health products and offering new treatment options. Europe was the first to develop a comprehensive regulatory framework for this sector as demonstrated by the PRIME program. Regarding vaccination, the Commission is also mobilizing its efforts to raise awareness and counter misinformation. For example, the Coalition for vaccination was set up in March 2019 and a summit on vaccination has been organized in collaboration with WHO. It will be held in September 2019.

We have adopted a comprehensive report on the experience of the legislation on pediatric medicines leading to the evaluation of the regulations for orphan and pediatric medicines. This evaluation should be completed by the end of 2019.

• What are the EU’s priorities in your health product policy?

A.B “It will be up to the next Commission to decide. However, as stated in the European Commission’s contribution to the informal EU27 leaders’ meeting in Sibiu (Romania) on 9 May 2019, Europe will continue to support high-quality, affordable and accessible health care for all citizens. One of the priorities would be to make Europe more attractive for clinical trials by providing standard rules for the harmonized, fast and transparent authorization procedure.”

• What do you think of the policy allowing early access to innovative medicines (PRIME)?

A.B “The PRIME (PRIority Medicine) program was proposed by the European Medicines Agency in 2016 to support the development of medicines that address unmet medical needs. Its objective is to optimize development plans and speed up the approval process to allow earlier access to promising medicines. This is achieved through greater interaction between EMA and medicine developers. In August 2018, the first authorizations that had been granted for the PRIME program were adopted by the Commission, i.e. for Car-T Cell medicines.”

• What are the interactions between EMA and the European Commission?

A.B “They are working together on the clinical trials portal to be implemented by EMA and they regularly cooperate on pharmaceutical issues such as falsified medicines, good manufacturing practices, shortages of medicines, the implementation of regulations on veterinary medicines as well as within the EUnetHTA joint action to create synergies between regulatory and assessment processes. The overall strategic objective of the network is to connect public regional and national HTA agencies, research institutes and health ministries by allowing effective exchange of information and supporting the political decisions taken by the Member States. We are currently in negotiation with the Council and the European Parliament for the adoption of the Commission’s proposal on health technology assessment. The aim of this proposal is to help bring innovative health technologies to patients, make better use of available resources and improve the predictability of activities. Joint high-quality clinical evaluation reports will help Member States make timely evidence-based pricing and reimbursement decisions and facilitate patients’ access to innovative technologies.”

• How do you define the relationships between patient organizations and European Commission departments? To which extent are they at the origin of the co-construction of European standards?

A.B “Patient organizations are an important stakeholder group for the Commission. They bring “real” experiences as well as knowledge and specific expertise in the scientific discussions on medicines and the impact of regulatory decisions. This collaboration increases transparency and improves regulatory processes. It is important that these organizations have no conflicts of interest with the pharmaceutical industry. The Commission maintains good cooperation with the HTA network stakeholder pool. Patients and/or their representatives also participate in a wide range of EMA activities, for example: the EMA management board and scientific committees, the “Patients’ and Consumers’ Working Party”, etc. The EMA scientific committee on orphan medicines was the first to welcome patients and/or their representatives as provided in the Orphan Drug Regulation of 2000[1]. Also, patients play a key role in the European Reference Networks (ERNs). In fact, these networks are specialized in rare diseases and attach great importance to the relationships with patients and organizations gathering patients at the European level such as EURORDIS.”

[1] Article 4, c) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicines.