EC Expert Panel proposes transparency, de-linkage and responsible licensing



Access to health

services in the European Union

approved this opinion for public consultation

by written procedure on 25 September, 2015

Public Consultation is open until November 8th, 2015

Expert Panel members

Pedro Barros

Margaret Barry, Helmut Brand, Werner Brouwer,

Jan De Maeseneer


Bengt Jönsson (Vice


Fernando Lamata

Lasse Lehtonen

Dorjan Maruši?

Martin McKee

Walter Ricciardi

Sarah Thomson

MEDICINES: p. 71 to 81 that includes this reference and the below recommendations.

The current system of funding R&D through medicine prices encourages

pharmaceutical companies to focus on areas likely to be most

profitable for them rather than areas in which there is unmet need.

The European Union could, however, find more effective ways of funding

R&D to meet health needs (Bloemen and Hammerstein 2012). An interesting line

of development would be to de-link prices and R&D costs (WHO 2012a; WHO

2012b). In 2010, Council Conclusions on the EU’s role in global health asked

Member Sates to explore this option and to ensure that EU investments in health

research secure access to the knowledge and tools generated as a global public

good and generate socially essential medical products at affordable prices.

Preliminary opinion:

The European Union can support

Member States in the following ways:

Promote joint action to develop a

strategy to ensure equitable access to new

medicines and new innovative treatments and fairer prices.

Promote transparency to ensure that patents serve the social purpose for which

they were created. This requires detailed knowledge of costs and prices. Wthout this information there is a risk of patent misuse.

Evaluate the possibility of

withdrawing patents in cases of misuse.

Consider setting up a European Parliament committee to analyse the prices of new

medicines. The committee should be guaranteed transparency around costs and prices.

Review the impact of the Supplementary Protection Certificate in ensuring access

to medicines (De Boer 2015).

Link products that have benefited from EU funds such as Horizon 2020 to socially

responsible licensing.

Explore models to separate the cost of R&D from prices (Council Conclusions May

10, 2010) and extend these to EU countries (not just low

income countries).

Evaluate and promote the use of joint procurement mechanisms.

Decouple the financing of EU regulator

y agencies (the European Medicines Agency,

EMA) from the pharmaceutical industry. Currently, 83% of the EMA’s budget comes

from the industry via authorisation fees).

Introduce stricter control over conflicts of