Recent legislative proposals from the European Commission to relax the prohibition on direct-to-consumer advertising (DTCA) of prescription medicines in the EU have generated increased debate internationally over the role of the pharmaceutical industry in relation to promotion, information and advertising and the impact of its activities on the public. It is argued that changing information technology and healthcare environments are leading people to take more direct control over their healthcare, although without the necessary health-literacy and critical appraisal skills to do so in a fully informed way. A comprehensive approach to patient information is proposed that would better equip people to take a more active and informed role in both self-care and shared decision making in relation to health, illness and drug and non-drug treatments.
MedawarC. (2001) ‘Health, pharma and the EU: A briefing for members of the European Parliament on direct-to-consumer drug promotion’ at http://www.socialaudit.org.uk/5111-005.htm.
2.
Royal Pharmaceutical Society of Great Britain (2003) ‘Mergers and takeovers within the pharmaceutical industry’, available at http://www.rpsgb.org.uk/pdfs/mergers.pdf.
UK Department of Health (2001) ‘The expert patient: A new approach to chronic disease management for the 21st century’, available at: http://www.doh.gov.uk/cmo/ep-report.pdf.
6.
‘OECD Health Data2003: ‘A comparative analysis of 30 countries’. Figures show that healthcare expenditure in Organisation for Economic Cooperation and Development (OECD) countries has grown more than one percent faster than their economies in the past decade and that OECD countries spent record amounts on healthcare in 2001. http://www.oecd.org/document/39/0,2340,en_2649_34631_2789735_1_1_1_1,00.html.
7.
108 million active European internet users are expected to be online by the end of 2001 — a 54 per cent increase from the 70 million online in 2000. This figure will rise to 255 million by 2004. See eEurope Report (2001) www.emarketer.com, April.
8.
RiskA.DzenowagisJ. (2001) ‘Review of internet health information quality initiatives’, Journal of Medical Internet Research, Vol. 3, No. 4, p. e28, available at http://www.jmir.org/2001/4/e28/index.htm.
The degree to which additional medicines provide an added therapeutic advantage or can be defined as ‘innovative’ is a subject of much debate. For example, (2001) ‘A look back at 2000. Overabundance and deregulation’, Prescrire International, Vol. 10, No. 52, pp. 52–54.
12.
Consumers' Association (2003) ‘Patient information: What's the prognosis? Completeness, bias and trust’, p. 59.
13.
‘Information need' is defined as ‘an individual's capacity to benefit from information’, see Consumers' Association (2003) ‘Patient information: What's the prognosis?’, (ref. 12 above).
14.
For example, from the website of the European Federation of Pharmaceutical Industries and Associations (EFPIA – http://www.efpia.org/4_pos/pharmareview/ReviewDTCI.pdf): • Informed patient: Possible ways forward (June 2003) • Information to patients: Position paper on the proposed modifications of Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use (Article 86 to 100) (June 2002).
ToopL.RichardsD.DowellT. (2003) ‘Direct to consumer advertising of prescription drugs in New Zealand: For health or for profit? Report to the Minister of Health supporting the case for a ban on DTCA’, available at: http://www.chmeds.ac.nz/report.pdf.
17.
National Institute for Health Care Management Research and Educational Foundation (2001) ‘Prescription drugs and mass media advertising, 2000’, Washington DC.
18.
National Institute for Health Care Management Research and Educational Foundation (2002) ‘Prescription drug expenditures in 2001: Another year of escalating costs’, Washington DC.
MeekC. (2001) ‘Direct-to-consumer advertising of prescription medicines: A review of international policy and evidence’, Council of Royal Pharmaceutical Society of Great Britain, available at http://www.rpsgb.org.uk/policy/index.html.
21.
GaleE. A. M. (2001) ‘Lessons from the glitazones: A story of drug development’, Lancet, Vol. 357, No. 9271, pp. 1870–1875.
22.
WoodA.J.J. (1999) ‘The safety of new medicines — the importance of asking the right questions’, Journal of the American Medical Association, Vol. 281, No. 18, pp. 1753–1754.
23.
Consumer Reports (1996) ‘Drug Advertising’, June, p. 62.
24.
BellR.KravitzR.WilkesM. (2000) ‘Direct-to-consumer prescription drug advertising, 1989–1998,’Journal of Family Practice, Vol. 49, No. 4, pp. 329–335.
25.
KoernerC. (1999) The regulation of direct-to-consumer (DTC) promotion of prescription drugs: Rockville, MD: Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration.
26.
PrattP. (2000) ‘The results of a regulatory compliance survey of direct-to-consumer advertisements for medicines’, Medsafe, Wellington, New Zealand.
27.
MoynihanR.HeathI.HenryD. (2002) ‘Selling sickness: The pharmaceutical industry and disease mongering’, British Medical Journal, Vol. 324, pp. 886–891.
Committee on the Environment, Public Health and Consumer Policy (2002) ‘Report on the proposal for a regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (COM(2001) 404 – C5-0591/2001 – 2001/0252(COD))’, 7th October.
30.
For example, the press statement from the European Commission referring to proposed legislative changes heads the relevant paragraph ‘Better information’. It then goes on to say that ‘The Commission considered [it] appropriate to abandon the strict prohibition of advertising of prescription-only medicines, since there is a growing interest and knowledge among the public for information on medicinal products.’ Available at: http://pharmacos.eudra.org/F2/review/doc/brief_m01_267_en.pdf.
31.
Similarly, Brian Ager of EFPIA (European Federation of Pharmaceutical Industries and Associations) states that, ‘In the US and New Zealand, companies are allowed to inform the public about their products through all media, from the internet through to broadcast media, including TV’, ‘Health on the web’, eurohealth, Vol. 6, No. 3, Summer 2000, available at: www.who.dk.
32.
Test-Achats (Belgium), OCU (Spain), CCA (Italy), DECO (Portugal), CLCV (France) (1997) ‘Leaflets in 5 European countries: Similarities and differences’.
33.
Consumers' Association (2000) ‘Patient information leaflets: Sick notes?’, June.
Pharmacia was acquired by Pfizer on 15th April, 2003.
36.
The advertisements ran during June 2003 and were the subject of an article in the Scottish Sunday Herald on Sunday 15th June, ‘Drug firm's obesity ‘advert’ should be banned, say GPs’, by Sarah-Kate Templeton.
37.
SheldonT. (2002) ‘Dutch GPs call for ban on Novartis products’, British Medical Journal, Vol. 325, p. 355.
38.
LaumannE.PaikA.RosenR. (1999) ‘Sexual dysfunction in the United States: Prevalence and predictors’, Journal of the American Medical Association, Vol. 281, pp. 537–544.
39.
MoynihanR. (2003) ‘The making of a disease: Female sexual dysfunction’, British Medical Journal, Vol. 326, pp. 45–47.
‘Pharmacy in the Future: Implementing the NHS Plan — a programme for pharmacy in the National Health Service' states that ‘patients will be able to obtain a growing range of medicines over the counter from pharmacies’. Additionally, that, ‘… the government will continue to encourage makers of medicines to apply for over-the-counter status for their products when it is safe and appropriate to do so’, available at: http://www.doh.gov.uk/pharmacyfuture/index.htm.
