HEALTHY RESPECT FOR ADVERTISING GUIDELINES IS CRITICAL IN KENYAN PHARMACEUTICAL SECTOR

By Mercy Mwaniki,John Syekei Friday, August 03, 2018
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Guidelines for advertising medicines and medical devices in Kenya have significant implications for industry players. Two cardinal points to note are that regulators are required to approve advertising proposals and that considerable emphasis is placed on maintaining the independence of health professionals.

In Kenya, regulation of the pharmaceutical industry is significantly more developed compared to regulation of other industries. The Ministry of Health regulates the industry through the Pharmacy and Poisons Board (the PPB), whose mandate includes regulating the advertising of pharmaceutical products in the country.

The PPB has issued guidelines that govern the advertising of medicines and medical devices in Kenya. The objective is to regularise all advertisements, promotional material and information on medicines available in Kenya, and articulate ethical criteria for medicinal drug promotion. The ultimate aim is to support and encourage the improvement of pharmaceutical care and promote rational use of medicines.

Regulator must approve advertising proposals

A clear indication of how seriously the advertising of medicines is being taken in Kenya is that advertising proposals must have PPB approval before being launched. The guidelines require any person intending to undertake any advertising or promotional activity to submit a proposal to that effect, together with accompanying material, to the PPB for review and approval before the launch of the intended activity. This effectively serves to protect consumers from false information and ensure that information supplied about medicines in advertisements is accurate, current, factual and not misleading in any way.

The PPB reserves the power to remove from the market and confiscate any material that it considers to be contrary to the advertising guidelines. These powers have been exercised in recent times and billboards containing information not approved by the PPB have been taken down. Additionally, the PPB is empowered to prosecute industry players who do not adhere to the advertising guidelines. Any person who fails to comply with the provisions of the guidelines commits an offence and is liable, on conviction, to a fine not exceeding one million Kenyan Shillings (approximately USD 10 000) or a term of imprisonment not exceeding two years, or both the prison term and the fine.

Independence of health professionals is paramount

One of the most important points to note in the guidelines is the necessity for companies to ensure that the independence of health professionals is maintained at all times. In this regard, advertising should not include giving any gift or benefit in kind that would influence the prescription patterns of healthcare professionals. In addition to this being an offence under the ambit of the PPB, it could fall within the definition of “giving a bribe” under the Bribery Act, which applies to both the private and public sectors.

Before advertising medicines and medical devices in Kenya, it is also important to bear in mind that:

  • Any interactions with healthcare professionals should be focused on informing health professionals about products, providing scientific and educational information and supporting medical research and education. Such interactions should be for the benefit of patients and to enhance the practice of medicine.
  • Healthcare professionals should maintain their independence at all times.
  • Advertising and promotion should encourage the appropriate use of pharmaceutical products and should not be exaggerated.
  • Only medicines and medical devices registered in Kenya can be advertised and the advertisement materials must be approved by the PPB.
  • Advertising prescription-only medicines to the general public is prohibited.

The PPB does not shy away from exercising its powers and has shown itself willing and able to act against industry players that fail to toe the line when advertising or promoting their products. Being fully conversant with the advertising guidelines is a prerequisite for any pharmaceutical company wishing to maintain a healthy presence in the Kenyan market.