The European Parliament will seek an increased EU role in regulating the pharmaceutical market and controlling rising drug prices, according to a draft report seen by euractiv.com.
Spanish Socialist MEP Soledad Cabezón Ruiz (S&D), who is the author of the Access to Medicines report, is calling for EU-wide measures on the pharmaceutical market to reinforce the negotiation capacities of member states in order to achieve fair prices for medicines.
The report was sent to all shadow rapporteurs in the Environment Committee last week, and will be officially presented on 12 October.
An EU Parliament source told EURACTIV that 20% of public health spending in OECD countries currently goes to medicines. “This is a big burden for the budget at times of cuts and austerity,” they added.
The European Parliament is calling on the Commission to “harmonise pricing and reimbursement criteria”, taking into account the level of innovation and the social and economic cost-benefit analysis.
It is also urging the Commission to propose a new directive on the transparency of price-setting procedures and reimbursement systems.
Member states’ leverage
The legislature is also asking the European Council to push for enhanced cooperation among the member states on price-setting procedures, in order to “share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays”.
In an interview with EURACTIV earlier this month, Bulgarian Health Minister Petar Moskov said that Sofia and Bucharest would soon sign an intergovernmental agreement to jointly negotiate the pricing and availability of medicines with pharmaceutical companies.
His views were shared by patient organisations, which met in Sofia on 12 September and explored ways of improving access to medicines and increasing states’ leverage in negotiating with the pharma industry.
“I think that the pharma industry understands that it cannot escape this tough conversation. It should stay at the table when we seek better solutions,” Stanimir Hasardzhiev, Patient Access Partnership (PACT) Secretary General, told EURACTIV.
Parliament Task Force
The parliament source predicted that there would be strong lobbying from pharmaceutical companies. “The last attempt to introduce transparency in pricing was blocked by the Council,” the sourced noted, adding though that last June, even the European Council admitted that there was a need for an analysis of the existing system of price setting, competition, and generics.
The report also emphasised the need for the Commission to examine and compare the price of medicines in the EU and to present an annual report to the European Parliament as well as for the creation of a task force to monitor the prices of medicines.
Patient-driven research
The study also focused on research and development (R&D) saying that it should be driven by patients’ needs “while fostering the social responsibility in the pharmaceutical sector.
“The Commission should set up an EU public platform for R&D funded by contributions from profits made by the pharmaceutical industry through sales to public health systems,” the legislature stressed, adding that transparency R&D costs should also take center stage.
In addition, EU lawmakers are encouraging the Commission to promote open data in private research, especially in cases where public funding is involved, and “to establish conditions such as affordable pricing and non-exclusivity, or co-ownership of IP for projects funded by EU public grants such as Horizon 2020”.
Background
In June 2016, EU health ministers stressed that patients’ access to effective and affordable essential medicines was endangered by “very high and unsustainable price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic strategies and that individual governments have sometimes limited influence in such circumstances”.
Member states have the full competence to decide which medicinal products are reimbursed and at what price, while the European Commission is exclusively responsible for the competition of medicinal products on the EU market.
Timeline
- 12 October: The report will be presented by the European Parliament's Committee on Environment (ENVI).