Firm proposal for legislation change put forward by EU Commission
After many years of discussion there is at last a firm proposal for legislation change that has the potential to affect significantly companies' communications with the public and patients about their prescription medicines. The proposal has already proved controversial and there is likely to be much more debate over coming months. That debate should be based on an informed understanding of the proposals. However reading the proposals raises many questions about what they will really mean in practice.
- Will they fulfil their objectives and result in improved access to important information on medicines for patients?
- Will there be a true harmonisation of what companies can do across Europe or will the current inequalities and uncertainties persist?
- Are the critics justified when they say that this could be the first step along the road to advertising?
- Is the proposal about liberalising or increasing restrictions on companies - or maybe a bit of both?
- What are the proposed control mechanisms on information quality and to prevent advertising prescription medicines to the public - are they sensible and appropriate or bureaucratic and difficult?
- How will codes of practice and regulatory controls work together?
- How will the innovative proposal for 'mutual recognition' of websites work?
These and many more questions are in the minds of those currently examining the proposals. This joint TOPRA/European Commission meeting provides a unique opportunity, early in the legislation process, to gain an understanding of what is proposed in 'Information for Patients' section of the Pharma Package, and to hear from the Commission, from those it will affect and from critical observers. It will help you to form your own views on what is to be welcomed and what might be improved. This will be an essential meeting for everyone who has an interest in companies' 'Information for Patients' activities and their regulation as well as those interested in Counterfeit medicines and Pharmacovigilance.
