Resume of the plenary debate on ACCESS TO MEDICINES in the EU
The European Parliament plenary witnessed last evening a vivid debate on the measures needed at EU and national level for ensuring availability and affordability of medicines in hard times of sustainability for national health systems. MEPs expressed their concerns that patients may be deprived of innovative medicines due to their cost in a debate with Latvian Secretary of State for European Affairs Kalniņa-Lukaševica and Commissioner Stylianides.
European Commission’s position
In its intervention, the Commission highlighted some of its initiatives already in place to tackle the issue of access to medicines:
• The Commission Expert Group on Safe and Timely Access to Medicines for Patients (“STAMP”) that held its first meeting 2 weeks ago.
This Expert Group will exchange views and information about the experience of Member States, examine national initiatives and identify ways to use more effectively the existing regulatory tools under EU pharmaceutical legislation with the aim to foster innovation and further facilitate safe and timely access to innovative medicines. The work of STAMP is coordinated by the Commission services on Health together with other relevant services and the EMA.
• A joint procurement agreement (developed by the Commission at the request of the Council for communicable diseases).
This mechanism enables member states to purchase medicines together so as to help secure access to medicines at better conditions and prices. Member states will purchase together drugs to fight communicable diseases, such as pandemic flu vaccines.
• Strategy on EU cooperation among HTAs (adopted by the Commission in October last year).
In the opinion of the Commission it is advisable to reduce fragmentation in the evaluation of technologies and by fostering exchange of information among European HTAs, which will ultimately speed up access to innovative treatments.
Council opinion expressed during the debate:
Ms Kalniņa-Lukaševica, in representation of the Council of the European Union, stated that the only way forward is a voluntary exchange of information among member states on pricing and reimbursement, which shall see also the industry involved. Such information sharing among member states’ competent authorities could take place in the Network of Competent Authorities on Pricing and Reimbursement established in 2008. There was also reference to the Council conclusions on innovation for the benefit of patients. The representative from the Latvian Presidency also mentioned the joint procurement as a means to lower cost on vaccines.
Opinions expressed by MEPs during the debate
Matthias Groote (S&D, Germany)
Mr Groote highlighted that there must be some sort of regulation to ensure that prices of drugs are brought down. He suggested to make better use of the available tools, like the network of European HTAs. He stressed on the important role the EMA can play in this regard and he questioned the Council and Commission whether they plan to finance future harmonisation measures. The same opinion on the need of a wider remit for the EMA was also expressed by Soledad Cabezón Ruiz (S&D, Spain).
Michele Rivasi (Greens, France)
Deplored the fact that there wasn’t a much needed resolution on this topic and highlighted the fact that there should be envisaged a joint system of procurement.
Piernicola Pedicini (EFDD, Italy)
He mentioned that we are currently witnessing a paradox in Europe with ever more expensive medicines and ever less innovation. He gave the example of CETUXIMAB that costs 80.000 euro/patient with a lung tumour with an average increase of survival of one month and a half and ERLOTINIB cost of 15.000 euro/patient with pancreatic cancer with an average increase of survival of 10 days. He concluded that for generics and biosimilars the pharmaceutical market should be freed up.
Jiří Pospíšil (EPP, Czech Republic)
Mentioned that even though health is a national competence the EU can still play a role in supporting a debate on generic drugs and patent protection.
Elisabetta Gardini (EPP, Italy)
In her speech she mentioned that the process of negotiation of prices of new drugs in Europe is too fragmented and this leads to the creation of unbearable inequalities: due to the current authorisation and reimbursement processes, drugs are not accessible to all EU patients at the same time, and the price of the new drugs varies greatly from one country to the other, without clear correlations to the cost of life in each Member States.
In her opinion, the price of new drugs should be based on equilibrate cost/benefit evaluations, but also on the impact of new drugs on patients quality of life and benefits for the society as a whole derived from longer survivorship, less hospitalisation costs and less burdening on Member States social systems. Elisabetta Gardini concluded her speech by emphasising that the EMA should be able to embed economic evaluations on new drugs within the process of authorisation of new medicines.
“At the same time, the EMA has to strengthen its collaboration with HTAs bodies in Member States, to ensure fair and equitable evaluation on the real benefits of new drugs.” She also stated that Regulation 726/2004, currently being revised, has to be amended way beyond the proposal of the Commission.
Kostas Chrysogonos (GUE/NGL, Greece) pleaded for a European policy for drug pricing.
Cristian Busoi (EPP, Romania)
Suggested the following possible solutions for patients to have access to innovative treatments:
• EU policy makers should make sure that regulatory decisions on the value of innovative therapies are based on what matters the most to patients: long-term quality survival;
• EU policy makers should ensure access to innovative treatments following a cost-benefit analysis performed at centralised level by the EMA;
• Prioritising at EU and national level more investment in research of innovative therapies;
• Include innovative therapies in national healthcare plans, treatment pathways and funding streams.
José Inácio Faria (ALDE, Portugal)
Deplored the lack of transparency in price fixing mechanisms and the enormous delays in decisions related to both innovative medicines and generics. In his opinion, the EU needs more negotiating power with the industry. Mr. Faria also deplored the fact that the revision of the Transparency Directive has been scrapped out from the new European Commission’s Work Programme.
ECPC opinion on the debate on access to medicines
Once again, the European Parliament demonstrated to be cancer patients’ closest political ally, pulling off a very interesting debate on access to medicines. We are glad that the views of cancer patients are shared by many MEPs, from different groups. The issue of access to medicines does not belong to one political group, as it does not affect only one disease.
The Commission’s message gives us hope, but still represents only the baseline for future, necessary developments.
Fostering the sharing of information on HTA assessment is vital. However we hope that, under the pressure of the European Parliament, the Commission will reconsider the much needed changes to the Transparency Directive and the Regulation on the authorisation of medicinal products. Europe must be united to exploit its true economic power. Enlarging the joint procurement agreement to all drugs, including oncology treatments, is the first necessary step in this direction.
We believe the EMA can successfully undertake a new responsibility in the moment a drug is registered namely, interacting with HTA experts and performing a cost-benefit analysis for each drug, thus facilitating the pricing for each member state. Such an undertaking can help to overcome disparities in the future.
We also think that pharmaceuticals have an undeniable role in medical innovation. However, it is likewise undeniable that more transparency on the real costs of R&D, production and distribution is necessary. Medicines are not a common commodity, and from last night’s debate, it is clear that the European Parliament agrees with us that Europe cannot afford leaving the market of pharmaceuticals unrestricted and unregulated.
ECPC will keep providing its contribution to this fundamental European debate, through our Working Group on “Europe of Disparities”. But it will be up to the European Parliament and the Commission to accept the challenge and make change happen. Last night’s debate kept our hope alive for a more equitable European healthcare.