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Insulin
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Diabetes
Trust
.
Direct to Consumer Advertising of Drugs
IDDT joins the campaign AGAINST the proposed relaxation of the EU ban on Direct to Consumer Advertising of Prescription Medicines
Update June
2003
The Health Council has rejected Article 88 of the Directive on the
Community Code relating to Medicinal Products for Human Use so
preventing Direct to Consumer advertising of drugs. A success for the
lobbying campaign!
The Background Information
The European Commission proposes an amendment to Article 88
of the Directive on the Community Code relating to Medicinal Products
for Human Use. This proposal will, for a five year period, permit
pharmaceutical companies to provide consumers with promotional
information on prescription only medicines [POMs] for the treatment of
asthma, diabetes and HIV/AIDS. This proposal is a move towards direct to
consumer advertising [DTCA] of drugs and it did not originate from
consumers or from the medical profession, many of whom have concerns
that it will invite full scale DTCA in the EU. DTCA of prescription
medicines is currently banned in every industrialised country in the
world, except the United States and New Zealand.
No evidence of benefit to
public health
There is no evidence that the Commission’s proposal on
Article 88 will benefit public health. The likely outcome will encourage
unsafe or unnecessary use of medicines and will lead to a sharp
escalation of healthcare spending on medicines.
There are several recent examples in the US where new drugs have reached the market after receiving fast track approval by the FDA and through advertising have become ‘blockbuster’ drugs before the adverse events started to be reported. One such drug was Rezulin [troglitazone] for the treatment of Type 2 diabetes which was only withdrawn after 92 deaths and large numbers of adverse events including liver failure.
Evidence that Direct to
Consumer Advertising threatens public health.
The United States has early 20 years experience of DTCA and
it is a grave threat to public health, putting the profits of the
pharmaceutical industry above public health.
It has been shown that DTCA:
-
Increases the stress on public health budgets. The evidence from the USA, one of the only two countries to allow DTCA, is that expenditure on drugs has increased greatly. From 1999 to 2000, 50 drugs were advertised and they accounted for a $9.94 billion increase in prescription drug spending. DTCA is likely to lead to increased expenditure on prescription drugs to the NHS.
-
Increases the amount of misleading and unhelpful health information
-
Increases the inappropriate and unnecessary use of medicines.
-
The enforcement of regulations controlling DTCA of prescription only medicines is difficult and costly and that violations are common and mainly due to pharmaceutical companies minimising information about risks and exaggerating benefits.
“First do no harm”
This is the EU’s precautionary principle and it seems that
this move towards DTCA does not adhere to that principle.
There is a need to improve the information on medicines that people receive and a need to ensure that Patient Information Leaflets are more reader-friendly and understandable. There is a need to ensure that health professionals and the public receive balanced, independent and comparative information about medicines and this must be based on the best possible evidence. Information from the manufacturers of medicines is unlikely to adhere to these requirements.
Update October 2002 – Europe
rejects drug advertising
Euro-MPs overwhelmingly voted against the European
Commissions proposal to relax the ban on drugs advertising direct to the
public.
In a vote of 494 to 42 the EU Parliament adopted an amendment that
removed the Commissions proposal to allow the pharmaceutical industry to
supply ‘disease information’ to people with asthma, diabetes and AIDS.
Supporters of the proposal have argued that ‘disease information’ from drug companies is not advertising and that patients need more information about the drugs that they are taking. No one would disagree with this sentiment but opponents of the proposal, including IDDT, believe that this information should come from independent sources and not the drug companies who have a vested interest in selling their products. They also believe that the wording ‘disease information’ was to disguise the underlying intent to move towards direct to consumer advertising of drugs.
The proposals will now go to the EU’s Council of Ministers before returning to the EU Parliament again. Let us hope that the MEPs once again give a resounding no to the proposal.
The campaign against relaxation
of the EU ban on DTCA of prescription medicines
In the UK the opposition to the EU proposal has been lead by
the Consumers’ Association. Health Action International [HAI] and the
European Public Health Alliance [EPHA] are strong opponents to the
proposal and are leading a campaign to try to prevent the changes. The
Standing Committee of European Doctors and Pharmacists of the EU are
opposed to the proposal stating “any relaxation of the ban on DTCA
would, without doubt, be detrimental to efforts to safeguard public
health.”
IDDT has joined this campaign because we believe that it is not in the best interests of people with diabetes that they should receive information about their condition from unbiased sources such as the pharmaceutical industry. We also believe that it is not in the best interests of people generally, healthcare professionals or healthcare systems.
To voluntary organisations
IDDT would encourage all voluntary organisations concerned with
healthcare to carefully consider the implications of the EU’s proposal
and the long-term ramifications. Many organisations have close links
with the pharmaceutical industry and many receive funding from them
either directly or indirectly but this may be reduced if the
pharmaceutical companies are allowed to reach the public directly by the
changes in regulations. An indirect effect of allowing the relaxation of
the ban on direct to consumer advertising could be that voluntary
organisations have curtail their activities if they cannot find
additional funding.
The campaign has been lead by:
Health International Europe
Jacob van Lennepkade 334-T
1053 NJ Amsterdam
The Netherlands
Tel +31 (0)20 683 3684 Fax +31 (0)20 685 5002
e-mail info@haiweb.org
Website
http://www.haiweb.org/campaign/DTCA.html
Our experience demonstrates the advertising power that industry can weald over apparently discerning medical and healthcare professionals. To allow industry to provide information direct to consumers, many of whom will be more trusting and less discerning than their medical team, can only be to the detriment of patients and their right to an informed, unbiased choice of treatments.