Gifts and inducements: Code of Marketing Practice set to regulate the pharmaceutical industry

For the past two years the pharmaceutical industry has been working on a Code of Marketing Practice. In many other countries multinational pharmaceutical companies are bound by the IFPMA Code of Pharmaceutical Marketing Practices. In the United States, many states now require pharmaceutical - and medical device companies and doctors to disclose payments made or received, whether such payments are for consulting services, research projects, gifts, etc.

The South African Code of Marketing Practice has been adopted by all the pharmaceutical trade associations. It is hoped that the Code will be promulgated under the latest amendments to the Medicines Act. This promulgation will also bring into force a Marketing Code Authority, which will be responsible for the enforcement of the Code. The Code allows any person to lodge a complaint on any violation of the marketing code. The Marketing Code Authority will also issue Guidance Notes from time to time, so as to provide practical examples of violations of the Code.

The Code contains two sections, one relating to marketing to professionals, and one relating to the marketing of medicines to patients (or the public). Some of the key provisions when marketing to the public include:

• Entry into competitions may not be dependent on buying a particular medicine and the value of the gift will be limited by the Code Authority.
  
• Testimonials by celebrities or sports people must comply with the indications approved by the Medicines Control Council (MCC), and such testimonials may not be older than three years.
  
• Restrictions are placed on the promotion of self-medication for serious health conditions, and the approval of the MCC has to be obtained.
  
• Advertising and/or promotion shall not claim that a product is ‘natural'.
  
• Claims for weight management, meaning weight-loss, measurement reduction, clothing size reduction and weight control / maintenance, can only be made in conjunction with reference to sensible lifestyle factors including a diet and exercise.
  
• The word ‘safe' or phrases containing reference to safety must not be used without adequate scientific substantiation.
  
• Exaggerated, all embracing claims or superiority claims must not be made and superlatives must not be used except for those limited circumstances where they relate to a clear fact about a medicine.
  
• The word ‘new' must not be used to describe any product or presentation, which has been generally available or any therapeutic indication, which has been available on the market for more than twelve months in South Africa.
  
• Advertisements should not be flippant or use inappropriate imagery or imagery out of context. Advertisers are encouraged to convey the message that medicines should be treated with respect and may not be suitable for some people.
  
• Advertising and/or promotion shall not suggest that a medical consultation or surgical operation is unnecessary nor shall it discourage consumers from seeking medical or pharmaceutical advice.

When marketing medicines to healthcare professionals, such as doctors, the pharmaceutical industry is bound by the following:

• No personal gifts may be given to healthcare professionals, and gifts have to be inexpensive, relevant to the practice or to patients and must be within monetary limits set by the Code Authority (currently around R200).
  
• When sponsoring professionals to attend congresses, the sponsor may only sponsor the costs associated with the academic activities of the congress, and it is preferable that sponsorships are paid to professional associations or conference organisors and not directly to professionals.
  
• A maximum of one cultural gift may be given to a profession per year.
  
• Meetings organised for patients, general public, individual or groups of doctors, other healthcare professionals and/or for administrative staff that are wholly or mainly of an entertainment, leisure, social or sporting nature is not permitted.
  
• All materials and activities must recognise the special nature of medicines, and the professional standing of the audience to which they are directed and must not be likely to cause offence.
  
• No unfair advantage may taken of the reputation of a brand, trademark, proprietary name or other distinguishing marks of another company, whether such company is in the pharmaceutical industry or not.
  
• Information, claims and comparisons, whether verbal or in writing, must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence, and must reflect that evidence clearly.

Prescription-only medicines may not be advertised to the public, but the Code permits patient education ("help-seeking advertisements") directed at the general public, provided that it does not contain the name of the specific medicine, does not make or allude to a medicinal claim, does not provide any risk information, i.e. it can only let the public know that treatment exists for a medical condition and must contain the phrase “For more information, refer to your doctor or pharmacist (or healthcare professional).

The Health Professions Council of South Africa (HPCSA), the statutory body that regulates doctors, physiotherapists, dentists, psychologists and other healthcare professionals, has ethical rules and policies relating to their relationship with the pharmaceutical- and device industries. The Perverse Incentives Policy prohibits professionals from preferentially using products in return for receiving some incentive or kickback. It also contains provisions similar to that of the South African Code of Marketing Practice in relation to sponsorships to congresses.