DG Enterprise and Industry conducted a public consultation on the future of pharmaceuticals between 19 July and 12 October 2007.
Stakeholders were invited to express their position on the basis of six general questions:
Do you agree with the analysis of the main challenges outlined by the Commission? Do you see other challenges?
Do you see other areas than those already targeted by the Commission where regulatory action should be taken?
What would you suggest as concrete measures to ensure the safety of medicines supplied in the EU, addressing in particular counterfeit medicines, and provision of high quality and affordable medicines also to third countries?
What can be done to improve Europe’s international competitiveness?
What can be done to foster convergence and transparency as regards pricing and reimbursement in the EU?
Do you think the current EU regulatory framework can accommodate emerging
technologies like regenerative and personalised medicine, as well as nanobiotechnology?
Contributors
The Commission received 104 contributions. Stakeholders can be classified into 10 categories: Patients (7 contributions); Pharmaceutical industry (42); Consumer Organisations (2); Consultants and law firms (4); Member States (11); Media (1); Research organisations (6); Individuals (8); Healthcare professionals (17); Others (6).
Summary of contributions
Broadly speaking, the vast majority of contributors agreed with the strategic outlook, key objectives and notions underlined in the Commission’s consultation paper. The major public health, scientific and economic challenges on which stakeholders focused on were the globalisation of the sector, the increasing fragmentation and internationalisation of the value chain, the smooth functioning of the internal market in a widening Europe, and advances in science and technology. However, some called for a more balanced scope, which places equal weight on both public health (safeguarding patients’ safety, improving access to medicines) and the competitiveness of the pharmaceutical sector.
Public health
A number of contributors voiced concerns that patients’ access to medicines is not uniform across the EU. Tackling
health inequalities, through the achievement of a genuine single market and the development of more affordable medicines, was therefore considered to remain as a major public health issue.
The vast majority of contributors stressed that counterfeit or deliberately and fraudulently mislabelled with respect to identity and/or source medicines can harm patients both at individual and societal level but also damage the credibility of a national healthcare system and called for EU action to tackle counterfeit medicines.
Some contributors stressed that the lack of effective oversight, inspection and law enforcement by the authorities may have facilitated non-compliant and illegal trade, especially involving the importation of pharmaceutical ingredients into the EU from foreign countries - mainly
from Asia - via certain brokers and traders.
There was support for Pharmacovigilance, that is strengthened implementation and reinforcement, through new legislative action, of the current EU regulatory framework on medicines safety monitoring.
A large number of stakeholders supported the provision of information to patients on medicinal products for human use. However, this was separated from the notions of ’direct to consumer’ or ’direct to patient’ advertising by the industry, which was not looked upon favourably.
Some contributions emphasised the role of patient information leaflets accompanying each medicine, while others suggested that the improvement of the availability and quality of patient information requires legal action.
Many stakeholders, in particular from the industry, commented on various issues related to clinical trials which are felt to become increasingly more difficult and burdensome in terms of resources.
The use of new genetic technologies was underlined as a new approach to drug development as well as unleashing the potential of significantly more effective diagnosis, therapeutics, and patient care especially with regard to emerging and life-threatening diseases.
Competitiveness and economic aspects
A number of contributors called for application of the ’Better
Regulation’ policy to all layers of the EU regulatory framework on pharmaceuticals.
It was suggested by many that rules governing post-authorisation changes to medicines (so-called ‘variations’), such as changes in the
manufacturing process, are too burdensome and could impair the introduction of changes that may enhance the quality of medicines. Action at EU level to simplify these rules was therefore strongly advocated.
The lack of sufficient policies to reward innovation and the focus on cost containment rather than the value of medicines to patients and society was considered by industry stakeholders to be an important factor for the future of pharmaceuticals, especially when it comes to decisions about new research and manufacturing facilities or other investments.
The majority of contributors clearly stated that pricing and reimbursement of medicines are the responsibility of Member States and that only modest movement towards convergence should be expected primarily due to the differences in EU health systems. However, the use of the guiding principles for good practice in pricing and reimbursement endorsed by the Forum and the flow of information that has allowed
Member States to better understand how other Member States deal with pricing and reimbursement were supported by many.
The development of a common methodology for relative
effectiveness based on best practices for early market access of innovative treatments as identified by the Working Group was a common theme across many contributions.
Some contributions referred to the need to maintain high
standards of intellectual property protection within EU and worldwide and address existing trade barriers.
Some respondents recommended that a suitable European master file
system for novel excipients is urgently needed to harmonize European and other markets.
Next steps
On the basis of this public consultation, the European Commission will address a Communication on the future of the EU single market in pharmaceuticals for human use to the Council of the European Union and the European Parliament in 2008.
This initiative is part of the Commission Legislative and Work Programme for 2008. The impact assessment accompanying the Commission Communication will outline how all contributions were taken into account.
For further information
The summary of all contributions
EPHA related articles
EPHA Consultation Response on "Information to Patients", April 2008
***Updated*** A European database on medicinal products: EudraPharm
