The EU legislative agenda around healthcare has been scaled back under the Juncker Commission, yet the debate around a number of hot topics seems to suggest a need for an EU presence. One of these hot topics is the patient access to medicines in the EU. An increase in new and innovative medicines represents not only hope for patients and a breakthrough for a number of diseases such as hepatitis or cancer, it is also accompanied by the inevitable concern around costs.

The pharmaceutical world is changing and after a few years of limited R&D advances, the industry is now developing innovative and lifesaving breakthroughs, tailored for patients in areas of high unmet medical need. Developing innovative medicines is costly and pharmaceutical companies commit to a lengthy and heavy investment process. Bringing a medicine from R&D to the market can take up to 13 years and cost 1,172 million € (2012 figure) while only one or two of every 10,000 substances become marketable medicines.1  These arguments put into perspective the high costs of innovations.

Due to many factors such as the economic crisis, healthcare systems are stretched and find themselves unable to meet such costs. As a result, the pricing and reimbursement methodologies and rationale is put into question. At the heart of all this are the patients and their desire to access affordable medicines and receive the information and support they need. To this mix, many more components can be added such as healthcare inefficiencies, global health aspects and an increased exchange of information on pricing between Member States.

So, is there a role for the EU? In the end, it comes down to a political decision. Juncker took the approach of limiting the EU’s activities to its strict competencies, giving Member States leeway to engage directly and independently of the EU in cooperation on healthcare matters.

Where is the current discussion heading?

  • New mechanisms to improve access to medicines for patients while addressing the sustainability challenges of healthcare systems could take the form of joint purchasing. In the field of orphan drugs, discussions are already well-advanced on the benefits for countries joining forces on price negotiations.2 Other discussion points, with interested Member States, include introducing differentiated prices that take account of objective economic and social assessments.3
  • Companies call for a reflection on new innovative approaches to value-based pricing, recognising the need for a longer-term view on economic and health benefits. A consideration is the “relative efficacy assessment”, which would have time benefits and provide the European Medicines Agency with a guidance for reimbursement.4
  • The debate also needs to be inclusive of its core: the patients. Patients who are empowered and supported can make a difference for the sustainability of healthcare systems.5 A number of initiatives and organisations are active in this field and seek to connect the dots.

As representatives of the European citizens, MEPs have been calling on greater transparency to bridge the gap between the EU and the national level by leveraging their constituencies.

The only legislative proposal that approached the pricing question was the announced revision of the Transparency Directive that was to consider the procedure Member States must respect to set price and reimbursement level. This has however been withdrawn by the Juncker Commission for lack of agreement mainly at Member States level and in the absence of coordination within industry. Ensuring high-levels of human health is enshrined in the Treaty. An enhanced cooperation in the spirit of Article 168 TFEU on EU action in the field of health would be better for everyone involved. There is scope to enhance a structured debate and political willingness, bringing meaningful support and concrete solutions to all stakeholders for a European model of healthcare.

1 Pharmaceutical Industry in Figures, Key data 2014,
2 EURODIS (European Organisation for Rare Diseases) and EPF (European Patients’ Forum) Call on payers,
3Belgium makes proposals on access to medicines, 3 June 2015
4 The EMA at 20: A quality model that deserves to be replicated, 12 March 2015
5 European Patient Forum, Campaign “Patients Prescribe” on patient empowerment,–the-epf-campaign-on-patient-empowerment/