European Union health ministers’ meeting last week in Romania addressed ways to ensure access to medicines and treatment, especially for youth or those with rare diseases. For innovative and expensive medicines, they discussed possibilities “for the time period between the granting of the marketing authorization, the actual placement on the market and the decision to reimburse the product in that Member State.”

The full Romanian Ministry of Health press release is included below.

Informal meeting of EU Health Ministers 14th – 15th of April 2019 Bucharest, Romania

Between April 14 and 15 2019, the Romanian Health Ministry organized the Informal Meeting of EU Health Ministers. The event took place at the Palace of Parliament in the context of the Romanian Presidency of the Council of the European Union and was chaired by Romanian Health Minister Sorina Pintea. The debate was attended by more than 140 delegates from the Member States of the European Union.

“The topics on the agenda were of political and strategic importance in the field of health. The proposed themes, namely patients’ access to innovative medicine and patient mobility, especially for patients with rare diseases or under the age of 18, are priorities for the Romanian Presidency of the EU Council in the field of health and have been discussed in depth today. In fact, Romania will continue its efforts to make progress on the agenda points which impact and benefit the health of European patients. The main purpose of our activities during this period is to guarantee access to the health system for all European citizens,” Minister Sorina Pintea said at the opening of the event.

The themes of the Informal Meeting in Bucharest are relevant to current concerns and aim to improve the quality of services and healthcare for European patients.

Regarding access to innovative and expensive medicines, EU Health Ministers were invited to exchange views on actions taken at national level, with the possibility that some of these actions could be implemented at EU level, as well as identifying the possibilities to ensure access to treatment for the time period between the granting of the marketing authorization, the actual placement on the market and the decision to reimburse the product in that Member State.

During the work, it was emphasized that rare diseases merit a special mention in the struggle to ensure early access to innovative medicines. Member State officials also discussed solutions to ensure access to equivalent treatments for all patients with rare diseases in the EU as well as ways to ensure access to treatment for patients enrolled in clinical trials at national level for the period since authorization, until the decision to reimburse the medicines is effective.

In the second session ministers discussed patient mobility and access to medical services for patients with rare diseases, especially patients under the age of 18 years.

Member State representatives debated the implementation of Directive 2011/24 EU on the application of patients’ rights in cross-border healthcare so that EU citizens benefit from the benefits of cross-border healthcare. Based on the experience gained, Member State representatives discussed how they can work together to improve the effectiveness of the Directive, taking into account the findings of the European Commission’s report on the implementation of the Directive and the February 2019 European Parliament resolution.

“There is clear information to improve access to planned cross-border healthcare. The availability of appropriate information and guidance can reduce the administrative burden of repetitive applications and unnecessary administrative procedures resulting from the authorization and reimbursement process. The reports of the Commission and the European Parliament on the implementation of the Directive identify a number of areas where improving information and increasing the transparency of the reimbursement process could lead to better informing the patients that are seeking cross-border healthcare,” said Minister Sorina Pintea Romanian Health Minister.

Also, in the session dedicated to patient mobility, the integration of European Reference Networks (ERNs) into healthcare systems in the Member States was discussed.

The European Reference Networks (ERN) are in the initial implementation / consolidation phase and are now facing a number of challenges to become operational and functional. They will truly be able to bring benefits to patients suffering from rare or complex and low-prevalence diseases across the EU only after they have been clearly and consistently connected to health systems in the Member States.

In regards to patients suffering from rare diseases, these are often children. Therefore, even if Networks support all age groups, many of the cases mentioned are those of minors. The meetings at the reunion were focused on identifying a set of policies and procedures that Member States put in place to incorporate / link these networks into their health systems.