These guidelines are set out in the MedTech Europe Code of Ethical Business Practice, which regulates all aspects of the industry’s relationship with HCPs and HCOs as well as the Guidance on the interactions between the medical technology industry and Patients Organisations. The Code covers support to medical education at third party organised events (TPOE), research & development as well as organization of company events, arrangements with consultants and gifts. It also introduces an independent enforcement mechanism and transparency obligations. Compliance with existing laws is not enough to protect the integrity and reputation of the industry. Currently, anti-corruption laws vary substantially across countries, even within Europe. The Code aims to offer a level playing field for companies operating in different markets while at the same time ensuring the highest compliance standards. The Code was developed as industry’s commitment to support clear and strict self-regulation to protect its reputation.
The MedTech Europe Code of Ethical Business Practice became binding for MedTech Europe corporate members on 1 January 2017. On 25 March 2022, a new version of the Code was approved. The 2022 revised Code reflects evolving business practices and was designed as the core document for ethics and compliance across the European medical technology industry. The revisions will be effective as of 1 January 2023, to ensure time for implementation and transposition by member companies as well as National Associations. Key changes include, among other things: revisions to provide additional clarity, new guidance on Collaborative Research, new definitions in the Glossary and an explanation of the existing Code provisions, as well as the consolidation and clarification of the existing rules around Distributor relations and Virtual Events.
EthicalMedTech: A dedicated compliance portal
EthicalMedTech is a unique platform dedicated to ethics and compliance projects in the healthcare sector. The following initiatives can be found there, as well as many other compliance resources:
- Conference Vetting System, MedTech Europe’s independent platform to assess the compliance of third-party educational events with the MedTech Europe Code.
- E4ethics, EFPIA’s evaluation platform for European third-party educational events
- Transparent MedTech, MedTech Europe centralised platform for member companies to disclose publicly the financial support they provide to independent medical education, via educational grants.
- Ethical Charter, which is a voluntary training and certification tool for Events Organisers to help raise awareness about industry’s ethical standards and facilitate industry’s support to independent medical education in line with the MedTech Europe Code.
In addition, the platform provides the following information:
- Links to the latest National Associations’ Codes
- Additional resources such as training material in different national languages.
In an international business environment, ethical business practices are a global issue. MedTech Europe works closely with industry associations around the world to raise standards across the industry and across the world. For example, through the involvement of MedTech Europe in the Global Medical Technology Alliance (GMTA). GMTA represents innovative companies that currently develop and manufacture 85 percent of the world’s medical devices, diagnostics and equipment. The GMTA has agreed a set of global principles of ethical business practices through a Joint Global Ethical Declaration.