UK: Doctors Must Fly Economy Class Under the New Code of Practice for the Pharmaceutical Industry

Last Updated: 27 February 2006
Article by Stella Wong

The belief that for every ill there is pill, has contributed to the expansion of the pharmaceutical industry. 650 million prescriptions are written each year by GPs alone and the pharmaceutical industry is now the third most profitable economic activity after tourism and finance.

A revised Code of Practice for the Pharmaceutical Industry (the "Code"), published by the Association of the British Pharmaceutical Industry ("ABPI"), came into operation on 1 January 20061. This tougher Code is a response to criticism in the Select Committee Report published on 5 April 20052. The report was produced following the first major Select Committee inquiry into the pharmaceutical industry for almost 100 years. The report stated that self regulation, along with the expansion of the industry’s influence, had led to the development of practices which acted against public interest. In particular, drug companies were criticised for excessive promotional activity and hospitality to prescribers. The report included the recommendation that there should be greater transparency in the activities of drug companies and greater restraint in the promotion of medicines.

Compliance with the Code is obligatory for ABPI member companies and in addition about 60 non-member companies have voluntarily agreed to comply with it. ABPI now represents about 75 companies which supply more than 80% of the medicines used by the National Health Service. The Code will be administered by the Prescription Medicines Code of Practice Authority (PMCPA) which was established by the ABPI in January 1993.

The aim of the Code is to ensure that the promotion of medicines to members of the UK health professions and to administrative staff is carried out in a responsible, ethical and professional manner to support high quality patient care. The Code also sets standards relating to the provision of information to patients and the public as well as relationships with patient groups.

The Code does not apply to the promotion of over-the-counter medicines to the general public nor does it cover the promotion of such medicines to health professionals when the object is to encourage purchase by the general public.

KEY CHANGES TO THE CODE OF PRACTICE

  • Safety

Prominent information about adverse event reporting should be provided on all promotional material.

  • The provision of hospitality, travel, accommodation and promotional aids to health professionals

The rules governing hospitality will be tightened – drug companies should only provide economy air travel to delegates sponsored to attend meetings. In addition any hospitality provided must not extend to a spouse unless that person is a member of the health profession or appropriate administrative staff.

The content of meetings must be the primary factor that attracts professionals to the event; hospitality must be secondary.

Promotional aids must cost no more than £6 excluding VAT – no other gifts or benefits should be offered to members of the health profession as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. Promotional aids which are for use in the home or car are unacceptable. Promotional aids are more likely to be acceptable if they benefit patient care.

Promotional competitions are banned since they trivialise information about medicines.

  • The provision of information to the public

Transparency is promoted and companies must declare sponsorships sufficiently prominently to ensure readers are aware of it at the outset. The promotion of prescription-only medicines to the public remains strictly prohibited. Firms must make a public list of all patient organisations to which they provide financial support.

  • Marketing of a drug

No more than eight mailings for a particular medicine may be sent to a health professional in a year.

  • Complaints

The Code promises to speed up the complaints procedures.

SANCTIONS

Where there is a breach of the Code, the company concerned must undertake to cease the practice in question and take all possible steps to avoid a similar breach in the future. Additional sanctions in serious cases include:

  • if the activity is considered likely to prejudice public health or safety then the company must suspend its use even if it is planning an appeal
  • naming and shaming of pharmaceutical firms for breach of the Code- a public reprimand by the ABPI board of management
  • a requirement for the recovery of a promotional item
  • the publication of a corrective statement; and
  • the carrying out of an audit by the PMCPA.

The Code does not introduce fines for companies since damaging a company’s reputation by naming and shaming is thought to be a bigger sanction.

The ultimate sanction for a company breaking the Code is expulsion from the ABPI.

The new Code has been criticised for "lacking teeth" – the biggest weakness of the Code being that it is regulated by the industry and written in such a way that it does not seriously inconvenience companies if anything goes wrong. Others have welcomed the changes.

Pharmaceutical companies will have until 30 April 2006 to meet the requirements of the new Code and promotional material or activity will not be regarded as being in breach of the Code if it fails to comply with its provisions until this date. The effectiveness of the Code will be evaluated by the ABPI in its annual reports.

Footnotes

1 See http://www.abpi.org.uk/links/assoc/PMCPA/pmpca_code2006.pdf

2 See http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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