Early next year, the European Commission will publish new guidelines for the pharma industry covering corporate social responsibility and access to medicines in Europe, a senior official has said.
Behind these developments is a feeling that there is "a level of mistrust, particularly between public authorities and the pharma industry," according to Thomas Heynisch of the Commission's directorate-general for enterprise and industry, who was speaking at the annual Gastein Health Forum in Austria.
"The Commission wants to move beyond codes of conduct but not to introduce new legislation," he continued. "Rather, we want guiding principles which can be a source of inspiration for those working within and beyond the pharma industry," Heynisch told the Forum, which is the largest gathering of healthcare policymakers in the European Union, and is held in the spa town of Bad Gastein in the state of Salzburg.
The forthcoming guidelines will be enforced at national level, the Forum was told.
A straw poll conducted at a Forum session held to discuss issues of transparency found that 97% of the doctors, legislators and industry representatives attending the session believed: the European healthcare system 'is struggling to cope' with both low levels of transparency and trust in the pharma sector.
The new European Commission guidelines will emerge from a Process on Corporate Responsibility in the field of Pharmaceuticals now underway at DG Enterprise and Industry with input from a wide range of stakeholders. The Process consists of three independent platforms, covering:
- transparency and ethics in the sector, within the context of the EU's reviewed Strategy for Corporate Social Responsibility 2011-14;
- access to medicines in Europe, in the context of pricing and reimbursement. This initiative has launched the following five projects, covering: a mechanism of coordinated access to orphan medicines, capacity-building on managed-entry agreements for innovative medicines, facilitating supply in small countries, promoting good governance for non-prescription drugs and market access for biosimilars; and
- access to medicines in developing countries, with a focus on Africa and, more specifically, the sub-Saharan region. Two projects are underway within this platform, one with the aim of facilitating access to patent information needed for medicines which are of particular interest to developing countries, and the second seeking to support local capacity-building.
Another session at the Forum heard proposals that differential pricing for innovative prescription drugs is a policy that should be developed further, as a way of improving access for patients in those EU member states hardest-hit by the financial crisis.
"The theoretical prediction of price differentiation is that it is welfare-increasing," said David Taylor, professor of pharmaceutical policy at University College London.
"Practically, this would translate into prices for prescription medicines that are affordable by different countries and avoiding the damaging effect of external price references and likely distortions arising from the operation of the single market," he noted.
"Ultimately, the EU and the member states will have to re-balance the focus between static inefficiency - or maximising the short-term benefit from a given budget - versus dynamic efficiency - in terms of incentivising R&D investment with a view to maximising the discovery of effective treatments for the benefits of patients and society," added Panos Kanavos, reader in international policy at the London School of Economics.
While the EU has embraced price transparency for prescription drugs, recent developments in the direction of risk-sharing and managed-entry schemes suggest that this may no longer be the case, delegates heard.