Lifting advertising ban could lead to more switches to pharmacy medicines
A wider range of pharmacy medicines could be available next year |
More medicines are likely to be switched to pharmacy medicine status next year as a result of plans to lift the current ban on advertising non-prescription medicines for a range of chronic diseases.
The Department of Health announced on 11 August that it plans to amend
the Medicines (Advertising) Regulations 1994 (see Panel). This will allow
a much wider range of medicines to be advertised to the public. New regulations
are expected to be put in place by the end of the year. The Medicines
and Healthcare products Regulatory Agency said that of 53 responses to
its consultation document MLX 288, 31 were broadly in favour of removing
the restrictions, although eight of these mentioned specific areas of
concern. Thirteen responses opposed the proposal or expressed significant
concern.
Areas where restrictions are to be lifted
• Bone diseases
• Cardiovascular diseases
• Diseases of the liver, biliary system and pancreas
• Endocrine diseases
• Genetic disorders
• Joint, rheumatic and collagen diseases
• Psychiatric diseases
• Serious disorders of the eye and
ear
• Serious gastrointestinal diseases
• Serious neurological and muscular diseases
• Serious renal disease
• Serious respiratory diseases
• Serious skin disorders |
Sheila Kelly, director of the Proprietary Association of Great Britain,
told The Journal that lifting the advertising ban will remove another
hurdle facing pharmaceutical companies that want to have their products
reclassified. “If companies can’t advertise their products
then switching is not going to happen,” she said. Last year, a
Royal Pharmaceutical Society working group produced a list of around
30 therapeutic areas in which it believed there were products that could
be reclassified as pharmacy medicines (PJ, 2 February 2002, p131). Mrs
Kelly said that without changes to the regulations, advertising would
only have been permitted for about five of these categories.
The Medicines and Healthcare products Regulatory Agency has already revised
its procedures for reclassifying medicines and companies can now make
applications at a time of their choosing rather than waiting for designated
slots every six months.
“There is a lot of work going on behind the scenes at companies,” Mrs
Kelly said. “The switches that are likely to occur will be complex
and will be accompanied by a range of information for patients and pharmacists.”
The PAGB will be leading the development of new therapeutic area guidance
on what can and cannot be said when advertising products in specific
categories. The new regulations will be put forward once this guidance
is finalised. Guidance will be developed first for Government priority
areas such as cardiovascular disease. The promotion of 75mg aspirin for
the prevention of heart attacks or strokes could be an early candidate
under the new rules.
Lord Warner, Parliamentary Under-Secretary of State for Health, stressed
when making the announcement that the ban on advertising prescription
medicines directly to the public will remain in place.
He added that a European ban on advertising products for chronic insomnia,
diabetes and other metabolic diseases, malignant diseases, serious infectious
diseases (including HIV and tuberculosis) and sexually transmitted diseases
to the public will not be changed. |
