You are probably asking yourself, why would a member of MassBio want to know about the MedTech Europe Code of Ethical Business Practices? Great question and I hope to answer that question with the highlights that follow. But first things first, if you aren’t familiar with MedTech Europe, they are Europe’s equivalent to AdvaMed, both are organizations that promote ethical standards, safety and economic policies in in the medical technology industry.
MedTech Europe revised the existing MedTech Europe Code of Ethical Business Practices not too long ago. While most of the changes will affect European healthcare meetings, the most important change to note for those of us here working in the US medical meeting industry is that MedTech Europe member companies will not be able to directly sponsor an HCP (healthcare professional), neither as a delegate nor as a speaker. Does your company manufacture overseas? Could this affect your sponsorship of HCPs attending third party events in the U.S. at HCOs (healthcare organizations or healthcare associations)?
It is also important to understand this change, even if your company is not involved in medical technology. Why? While it currently affects the med tech industry, many times rules, regulations and/or laws applied to one industry are then applied to other industries, especially during this time where there is a call for increased transparency and reporting. So is important to be in the know, it could very well help you navigate the waters when your industry sector is affected by similar mandates.
So what is MedTech Europe Ethical Codes?
New MedTech Europe Code of Ethical Business Practice went into effect January 1, 2018, and impacts the direct sponsorship and support of HCP attendance to third-party events by member manufacturers (medical technology companies). Direct sponsorship of individual HCPs will no longer be allowed. Instead, funding will need to occur through educational grants to minimize influence. The burden of this new educational grant system will fall onto the shoulders of the HCO. Manufacturers will not know the individuals they are sponsoring through the grant process, very different from how it used to be, with the manufacturer sponsoring individuals of their choice.
When do these codes go into effect?
January 1, 2018. Yes, already starting to be implemented…so lots of discussions!
What prompted the codes to be enacted?
According to MedTech Europe, the new Code is a clear directive from the medical technology industry to guard their relationship with HCPs by adopting clear and strict self-regulation.
What are the main tenets of the Code?
- The advancement of medical technologies
- Safe and effective use of medical technology
- Research and education
Highlights of major changes to the code:
- Phasing out direct sponsorships
- Transparency of educational grants
- Creating new rules regarding general criteria for events
- Creating new rules regarding demonstration products and samples
- Agreed definitions
- A common, independent rules of enforcement
Most change starts out with resistance and many questions, which is not unusual. So time will tell how the adaptation of the revised code will play out. But rest assured that codes, regulations and laws that promote transparency in the healthcare industry in general, are not going away, in fact quite the opposite is occurring.
This is just a brief overview of a much more complex code. For more information regarding MedTech Europe codes, visit their website. It has great information as well as a dedicated email to ask questions: email@example.com.