Public consultation (MLX 358): The European Commission proposals on information to patients for prescription medicines

On 10 December 2008 the European Commission published a legislative proposal for the pharmaceutical industry to be able to disseminate certain information on prescription medicines directly to patients. This was part of a wider pharmaceutical package that also included provisions on pharmacovigilance and counterfeiting.

The consultation sought views on proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 to provide a clear framework for provision of non-promotional information by marketing authorisation holders about their prescription-only medicines to the general public.

Public consultation (MLX 358): The European Commission proposals on information to patients for prescription medicines (205Kb) 

The UK government supports the proposal and wanted to engage with stakeholders to gauge public opinion in the UK. The MHRA launched the consultation in May 2009 to see if stakeholders supported the proposal, agreed with the UK government's position, envisaged what the impact might be of the proposals in the UK and any positive and negative public health consequences.

The deadline for responses was 14 August 2009 and 54 responses were received. Overall the majority of responses agreed with the government's position.

Summary report and the UK government response to the consultation

Summary report on the issues raised by participants (108Kb)

UK government response to the consultation (64Kb)

Responses

Agreed with the proposal
British Generic Manufacturers Association (BGMA) (1109Kb)
Datapharm (123Kb)
Faculty of Pharmaceutical Medicine (103Kb)
Fulcrumpharma (51Kb)
Gilead Sciences International Limited (19Kb)
Health Protection Agency (HPA) (65Kb)
Johnson & Johnson (419Kb)
Norgine BV (1562Kb)
Patients' Association (11Kb)
Periodical Publishers Association (61Kb) (189Kb)
Pharmaceutical Information and Pharmacovigilance Association (PIPA) (35Kb) (61Kb)
Roche (176Kb) (35Kb)
Royal College of Physicians of Edinburgh (RCPE) (18Kb) (176Kb)
Shire Human Genetic Therapies (284Kb) (18Kb) (284Kb)

Agreed with the proposal in part
Association of independent multiple pharmacies (AIMp) (49Kb)
Association of the British Pharmaceutical Industry (ABPI) (40Kb)
British Medical Association (BMA) (46Kb)
Company chemists' Association (CCA) (49Kb)
Diabetes UK (70Kb)
Epilepsy Action (766Kb)
European Industrial Pharmacists Group (129Kb)
Family Planning Association (65Kb)
Prof Jenny Hunt (108Kb)
National Pharmacy Association (NPA) (49Kb)
Pfizer (157Kb)
Pharmaceutical Services Negotiating Committee (PSNC) (49Kb)
Prescription Medicines Code of Practice Authority (PMCPA) (1541Kb)
Proprietary Association of Great Britain (PAGB) (42Kb)
Pelvic Pain Support Network (189Kb)
Royal Pharmaceutical Society of Great Britain (RPSGB) (60Kb)

Disagreed with the proposal
Age Concern/Help the Aged (142Kb)
BUKO Pharma-Kampagne (549Kb)
Drs O’Leary Lambe & Larkin (65Kb)
Dobbin, Alastair Dr (132Kb)
Dunn, James Dr (57Kb)
Health Action International (HAI) Europe (81Kb)
Healthy Skepticism (72Kb)
Insulin Dependent Diabetes Trust (IDDT) (66Kb)
International Society of Drug Bulletins (ISDB) and Medicines in Europe Forum (MiEF) (277Kb)
Kamal-Yanni, Mohga Dr (62Kb)
Mind (68Kb)
Murdoch, Liane (104Kb)
No free lunch group UK (39Kb)
Patient Liaison Group, Royal College of Surgeons (England) (59Kb)
Picker Institute Europe (104Kb)
Royal College of General Practitioners (RCGP) (31Kb)
Which? (113Kb)
Williams, Lindy Dr (44Kb)

No comment
Advertising Standards Authority (ASA) (102Kb)
United Kingdom Clinical Pharmacy Association (210Kb)

Not stated
Hall, Jonathan Mr (10Kb)
Isaacson, Keith (58Kb)
Jones, Laura Dr (14Kb)
Norsworthy, David Mr (12Kb)