The UK’s Medicines Control Agency has proposed a significant increase in the number of serious aliments for which OTC drugs can be advertised to the public.
Who: The Medicines Control Agency ("MCA")
When: December 2002
The UK's statutory drugs watchdog the Medicines Control Agency ("MCA") has issued proposals for a significant relaxation of the regime for advertising drugs in the UK. The present position is that under the Medicines (Advertising) Regulations 1994 as amended, medicines cannot be advertised to the public as capable of treating certain conditions, even though they are available "over the counter" ("OTC") without a prescription and can be sold by pharmacies for that purpose. The conditions in question include bone diseases, cardiovascular diseases, joint and rheumatic conditions, serious disorders of the eye and ear and serious skin disorders.
Relevant day to day examples in this category include the use of aspirin 75mg tablets for secondary prevention of heart attack or stroke and the use of products containing calcium and vitamin D by patients with osteoporosis. Other examples, although the MCA cautions that particular care will be needed by advertisers to ensure that patients are referred for further medical investigation where necessary, are nitrates for angina and fish oils for hyperlipidaemia.
In taking this initiative, the MCA indicates that there are symbolic as well as practical aspects. The symbolic aspect is the government's aim of empowering patients, ensuring that they have a sensible knowledge of their conditions so that they can take personal responsibility for their management, work in partnership with health and social care providers and generally have greater control over their lives.
The MCA accepts that there may be a need to invest in pharmacist training and education before promoting the relevant medicines to the public and indicates that professional guidelines covering the supply of these products from pharmacies could be developed if considered necessary.
The MCA will also proceed with caution if the proposals are adopted. A priority list and guidelines on best promotion practice will be drawn up in conjunction with industry and other stakeholders. Also, advertisements for products following their reclassification under these proposals will be reviewed by the MCA before being aired for the first time and subsequently, regularly reviewed. Responses to the consultation document are requested by 27 January 2003, and one imagines that if all goes according to plan the relevant regulatory changes may be brought into effect by mid to late 2003.
Why this matters:
To some extent driven by drug information feely available on the internet, as well as permitted advertising of prescription drugs in the US, there has for some time been pressure on this side of the Atlantic to improve drug information that is available to consumers. Alongside this MCA initiative here in the UK, the European Parliament completed only last month a first reading of proposals on the part of the European Commission for reforms of EC legislation on pharmaceutical products. Although these do not include any proposal to remove the ban on the advertising of prescription drugs, they do suggest some initiatives in the area of providing better information to patients.
Proposals would enable patients to get appropriate and officially authorised information about drugs available on prescription if they so requested it from the relevant manufacturer.
On marketinglaw, we have consistently argued that in the interests of greater consumer empowerment and information, the inevitable end result of this process has to be the removal of the ban on advertising of prescription drugs in Europe, subject of course to comprehensive controls. These two steps take us further down the path in that direction.