english.prescrire.org > Positions > Regulatory issues > Distinct and separate roles

Theme: Regulatory issues

Drugs regulatory bodies ought to be the public’s principal defence against medicines that are useless, unproven or downright dangerous. Yet regulators increasingly depend upon financing from the pharmaceutical industry itself.  

Distinct and separate roles

At their core, all healthcare activities centre around the needs of individual patients who are seeking help to deal with a health problem. Any confusion between the roles of the different players in the healthcare system undermines not only overall quality of care, but also patients' freedom to base treatment choices on their individual needs.

During the last few years, pharmaceutical companies have repeatedly tried to impose advertising of prescription-only medicines on the European public. They have lobbied national and European decision-makers, sponsored so-called "patient groups" that have conveniently sprung up as needed, and have invented a number of new marketing tools. The latest is an attempt in France to set up programmes that are being represented as helping individual patients better adhere to treatments.

The pharmaceutical lobby exerts continuous pressure on the other players in the healthcare arena (patients, health professionals, and government agencies). One of the industry's key tactics is to maintain confusion concerning its own role and that of these other players.

At their core, all healthcare activities centre around the needs of individual patients who are seeking help to deal with a transient or chronic health problem. Patients' ability to choose between the various available treatments must be preserved. It is up to them to select the treatment that best meets their needs among those that are recommended. It is also up to them to raise questions about their treatment at any time, depending on their symptoms, their subjective wellbeing, and their personal priorities.

One of the conditions of being properly informed is to be able to maintain the freedom to accept or reject a specific medical treatment, or to continue or stop ongoing treatment. Independent patient groups, that are created by patients themselves and are able to resist the influence of drug companies, can act as a source of relevant and reliable health information.

Health professionals can fulfil their role effectively when they are properly trained and informed, and when they maintain sufficient independence to be able to provide reliable advice to their patients. Part of their professional responsibility involves providing patients with comparative information in order to make informed individual treatment choices. Government agencies should help health professionals to fulfil their role by facilitating access to unbiased information on health conditions and treatments. They must maintain a focus on public health and protection of the public interest, and resist pressure from private commercial interests. They also have a role in ensuring equitable allocation of available healthcare resources, in order to ensure that all patients have ongoing access to effective and well-evaluated medical treatments.

The role of the healthcare industries is to provide health professionals and patients with drugs and medical devices that have a well-established and positive risk-benefit balance, and that are adapted to patients’ needs.

Any confusion between the roles of the different players undermines not only overall healthcare quality but also patients' freedom to base treatment choices on their individual needs.

©Prescrire 2008

Prescrire Int 2007; 16 (88): 46.