Before the 2nd Surgicon Congress in 2013, a special investigation was performed by a lawyer from the Swedish Medtech organisation, to investigate all the existing ”rules and regulations” concerning compliance and collaboration between private device industry and surgeons employed in publicly financed healthcare. This work resulted in the finding of five main principles that were common for the existing regulations worldwide.
If all the five principles below were followed, the requests of all the laws were fulfilled:
1 Principle of Transparency
Interaction between industry and health care, or medical staff, should be open and transparent and performed in compliance with applicable laws, regulations, business codes and codes of conduct.
2 Principle of Documentation
When a service is performed by the health care, or medical staff, for the industry the following data must be agreed in writing:
– the purpose of the interaction
– the service to be performed or
– what the contract would otherwise cover, and
– to what extent and
– how compensation should be made, and
– the compensation to be paid.
Likewise documentation should be made in case of industry funding of health care, or medical staff, or when other benefits are transferred from industry to health care, or medical staff. Adequate documentation such as the agreement, related reports, invoices, etc. must be retained by the parties to support the need for, and content of, the relevant relationship and to determine the reasonableness of compensation paid.
3 Principle of Proportionality
Agreements between industry and health care, or medical staff, about their respective commitment should be in good proportion to one another. In addition, compensation must be proportionate, reasonable, and correspond to the market value of the service rendered.
4 Principle of Moderation
Arrangements in any way supported by the industry should be permeated by moderation. The requirement for moderation means that the benefit may not seem to affect the behavior of the recipient. Interaction between industry and health care, or medical staff, should thereby not involve undue influence, and should not compromise, or be perceived to compromise, the independence of health care professionals.
5 Principle of Mutual Benefit
Arrangements where the industry make any contribution to the participation by medical staff, the participation should be clearly linked to the company’s normal activities, and equally of value to the healthcare provider.
Surgicon’s 5 Principles for professional interactions between surgeons and industrial parties 2013 were based on:
Samverkansavtalet (SWE)
http://www.swedishmedtech.se
Eucomed Code of Ethical Business Practice (EU)
http://www.eucomed.org
Advamed Ethical Code (USA)
http://www.advamed.org
CMSS (USA)
http://www.cmss.org
EFPIA Code of Conduct
http://www.efpia.eu/code-conduct
IFPMA Code of Conduct
http://www.ifpma.org/ethics/ifpma-code-of-practice/ifpma-code-of-practice.html
UK Bribery Act
http://www.legislation.gov.uk/ukpga/2010/23/contents
