The declaration of links of interest - Principle 7

In order to comply with Principle 7, all means of financing the site or application must be clearly stated. 

In addition, it must be indicated on the site or application whether or not the authors of the content are health professionals and/or have links of interest with health products and cosmetics companies.

This part of the principle being a little complex, but nevertheless essential, you will find the necessary information in this article.

As legislation varies from country to country, we focused mainly on France, Switzerland, Belgium and the United States.

 

For sites in France : 

Source: Ministry of Social Affairs and Health

The law of 29th December 2011 on strengthening the health safety of medicines and health products required the publication of links between health and cosmetics companies and health professionals. 

L. 1453-1 of the Public Health Code (CSP) introduced by Article 2 of Act No. 2011-2012 of 29th December 2011 aims to ensure greater transparency and improve public information regarding the existing links between companies producing or marketing products for human health or cosmetics or providing services associated with these products, on the one hand, and the various actors involved in the health field, in particular health professionals, on the other.

The "transparency" system, by allowing citizens access to the information it targets, ensures them an objective assessment of the relations between health professionals and industry. In this way, it helps to dispel any suspicion of independence, particularly of health professionals, learned societies and the specialised press, when facts are revealed that could undermine the necessary trust between the citizen, as a user of the health system, and the actors in this health system.

For companies: 

The obligation to advertise applies to companies producing or marketing products under the jurisdiction of the Agence Nationale de Sécurité du Médicament et des Produits de santé (ANSM), and to companies providing services associated with these products.

Either companies producing or marketing products for health or cosmetic purposes intended for men; and companies providing services associated with these products. 

For health professionals:

  • Physician 
  • Dental surgeon 
  • Midwife 
  • Pharmacist 
  • Pharmacy preparer and hospital pharmacy preparer 
  • Nurse 
  • Massager-physiotherapist 
  • Pedicure-podiatrist 
  • Occupational therapist 
  • Psychomotor therapist 
  • Speech-Language Pathologist 
  • Orthoptist 
  • Medical electro-radiology manipulator 
  • Medical Laboratory Technician 
  • Hearing care professional 
  • Lunar-optician 
  • Prosthetist and orthotist for the fitting of disabled people 
  • Dietitian 
  • Caregiver Assistant 
  • Childcare Auxiliary 
  • Ambulance driver

When they conclude agreements or receive benefits in the ordinary course of their profession, and not when they act in their capacity as consumers.

 

But also:

  • associations of health professionals
  • students whose studies are intended for the professions listed above as well as associations and groups representing them
  • approved associations of users of the health system
  • foundations, learned societies and companies or advisory bodies involved in the products and services sector
  • press publishing companies, publishers of radio or television services and publishers of online communication services to the public
  • publishers of software to assist in prescription and dispensing
  • legal persons providing or participating in the initial training of health professionals

The 2 parties concerned are required to declare the links of interest, a database has been set up to make all this information accessible.

Any benefit, in cash or in kind, of a value greater than or equal to €10 will be made public.

The nature of this benefit (which may take the form of a meal, an invitation, a book, etc.) and the existence of agreements (e.g. research or collaboration agreements) will also be made public.

 

More information:

Circular

Article L1453-1 of the Public Health Code

Interesting information on the subject

  

For Switzerland: 

In 2002, the Swiss Academy of Medical Sciences published for the first time "Recommendations for collaboration between medical professionals and industry". These were revised in 2005 and became "guidelines", which came into force in 2006. The guidelines have been incorporated into the WFH Code of Ethics. In addition, the SAMS has set up a consultative commission for collaboration between the medical profession and industry. Since then, this committee has supported the implementation and helped to interpret the guidelines.

The guidelines apply to the relationships of the medical profession with suppliers in the health market, in particular with companies in the pharmaceutical and medical products industries.

In doing so, they must contribute to a correct approach to conflicts of interest when compensating physicians' services through financial or other benefits. The purpose of the guidelines is to help promote the objectivity and quality of the activities mentioned, improve transparency, avoid dependencies and manage conflicts of interest in an informed manner, by recommending the conduct to be adopted on a daily basis.

More information

  

For the United States:

Sunshine Act is a transparent conflict of interest regulation that requires pharmaceutical companies and MedTech manufacturers to publicly disclose, from 2013, all payments (gifts, privileges...) made to doctors and medical institutions (training or care institutions).

New provisions are being prepared. The obligation to declare will also concern other forms of conflicts of interest occurring in the practice of health professionals and at several levels of the drug and care circuit (Center for Medicare and Medicaid).

Overview of the new provisions:

  • Public declaration of all amounts paid (greater than $100 per calendar year) by pharmaceutical companies to physicians and university hospitals in the United States
  • This text also applies to doctors or their close families who hold shares in  MedTech companies or pharmaceutical companies whose products are for sale in the United States. The latter must complete a declaration indicating the amount of the investment and the related terms and conditions.

USA database

More information

 

For sites in Belgium: 

Following, among other things, discussions on WHO or French governmental guidelines on H1N1 influenza, public and media attention is focused on the conflicts of interest of scientific experts.

The High Council of Health (HSC) is the first scientific advisory institution in Belgium to have developed its own philosophy and implemented a comprehensive approach to the management of declarations of interest and possible conflicts by a Committee on Ethics. 

More information

Article

Article

Belgium database

Information