On Friday 21 June in Luxembourg, the European health ministers confirmed their differences over the system of incentives in the proposed pharmaceutical package.
Denmark, Sweden and Italy have presented a document (https://aeur.eu/f/crv ) in which they oppose the incentives proposed by the European Commission in its proposals on the reform of pharmaceutical products.
The Belgian Presidency of the Council of the EU, before handing over to the Hungarian Presidency, suggested that the modulation of data protection and the market should be seen as an important tool for encouraging companies to achieve essential public health objectives. It proposes to keep this modulation as a guiding principle for the negotiations, but considers that it is too early to set the duration of the reduction in basic data protection (which is reduced from eight to six years in the Commission's proposal and from eight to seven and a half years in the European Parliament's position).
Denmark takes the view that access to medicines and the industry are not in conflict, but complement each other. “A complex modular approach would not meet the objectives”, according to the Danish minister, who, like Italy and Sweden, wants to retain an eight-year protection period. France also defended maintaining the status quo of the eight-year base period.
Slovenia and Finland supported the proposal (six-year duration). Spain has said it is prepared to accept seven years (with an additional 12-month period subject to conditions).
Incentives to enter the market: four options. The Belgian Presidency of the Council has suggested four options in this area. The first three involve a progressively less rigorous definition of the efforts that the company should make in order to benefit from the incentive under the modulation system. The fourth option dissociates the issue of access from the incentive-based structure and formulates a proposed solution based on an obligation. Some support has been expressed for option 1 (Slovenia), while other countries, such as Denmark, Luxembourg and Germany, prefer option 4.
With regard to access to medicines, France has said that it favours scenarios other than modulation of the protection period, such as “an obligation to submit a price and reimbursement dossier”. To this end, a register could be set up to ensure that applications for prices and reimbursements have actually been submitted, according to the delegation. Finally, France has advocated granting market exclusivity for orphan drugs.
In addition, most of the ministers supported the idea of incentives for the development of medicines to meet unmet needs.
Hungary has stated that its objective is “to find solutions to facilitate access to medicines and strengthen the competitiveness of the industry. We hope to be able to make rapid progress “ on this issue, said the Hungarian delegation.
Stella Kyriakides, the European Commissioner for Health, believes that a balance needs to be struck between innovation and meeting patients' needs. “Today, not all patients in the EU have the same access to innovative medicines. We cannot have first- and second-class citizens in the EU”, she lamented. She called on the Council to roll up its sleeves and finalise an agreement as quickly as possible.
At the end of the debate, the Belgian Presidency of the Council took the view that a majority of Member States were in favour of modulation,”provided that the needs of innovation are respected”. A minority of countries support the current framework.
Various countries believe that access to medicines should not be linked to pricing and reimbursement. “We need an access solution, but we don't agree on how to achieve the objectives”, said Frank Vandenbroucke, the Belgian minister.
Link to the document setting out the options and questions: https://aeur.eu/f/cs5
The Council of the EU has also adopted its recommendation on vaccine-preventable cancers. Every year in the EU, almost 14,000 lives are lost to cervical cancer and over 16,000 new Hepatitis B infections are reported., noted Ms Kyriakides. “With safe and effective vaccines, and with our collective target to vaccinate 90% of girls against HPV and increase Hepatitis B vaccinations, we have an historic opportunity to eliminate cervical cancer and other cancers caused by these viruses”. (Original version in French by Lionel Changeur)