MedTech Europe Code 10th anniversary: what does the next decade hold?

Ten years on from the adoption of the MedTech Europe Code of Ethical Business Practice, our industry’s relationship with healthcare professionals and healthcare organisations has changed for the better. Together, we have delivered greater transparency and earned higher levels of trust from regulators, partners and, crucially, patients. 

Now, as we mark the tenth anniversary of the Code, it’s time to acknowledge the enormous collective achievements to date, and to think about the future. 

We see new opportunities to expand the geographical reach of our work, and to deepen our collaboration across the life sciences. As a review process is built into the Code every five years, we are now preparing to embark on a period of reflection. To ensure we continue to have a widely respected and pragmatic document, the input of companies and industry partners is vital.

A brief history 

First, let’s take a step back and consider how we got here. While the MedTech Europe Code was adopted in 2015 and implemented from January 2016, the story goes back a little further. In fact, the roots of today’s document can be traced back to the 2006 Eucomed Code, which was drawn up by medical device companies. This was a shorter, more modest statement, but it was an important first step towards a unified position on ethical business practices. 

A more robust version was published in 2012, followed by the first version of the Conference Vetting System, introduced on a voluntary basis in 2014 before becoming mandatory the following year. 

A crucial milestone was the establishment of MedTech Europe, bringing together the medical devices (Eucomed) and in vitro diagnostics (EDMA) sectors. This paved the way for the 2015 Code, which introduced a ban on direct sponsorship and significant transparency measures. 

Following a transition period, key elements of the Code came into effect in 2017. By January 2018, MedTech Europe member companies were obliged to cease direct financial and in-kind support for individual healthcare professionals’ attendance at third-party educational events. 

Building trust 

It’s important to recall the conversations that were taking place at the regulatory level at that time. It had become clear to those of us working in the field of compliance that policymakers and regulatory authorities were looking closely at how industry interacted with partners across the healthcare ecosystem. At the national level, some countries were drafting tighter rules on education, gifts, and other support. The times were changing, and our industry had to change with them. Better still, we decided to lead the way. 

By establishing a compliance network – now known as the Ethics and Compliance Committee – MedTech Europe created a forum where members could work through the practical realities of enforcing the code. It was, and is, a crucial platform where compliance professionals can ensure alignment on how the Code is interpreted and implemented. 

Not only did this help to deliver a level playing field, in which members would work to apply the same rules in the same way, but it also helped to ensure the Code struck the right balance between rigour and pragmatism. Along the way, our sector built trust with regulators, earned the confidence of our members, and strengthened links with colleagues across the life sciences. 

Conference vetting 

While, with the benefit of time, this may all appear to have been smooth sailing, there were plenty of challenges along the way. One of the key issues was how to navigate the need for valuable medical education events while adhering to the new standards of ethical business practice. 

From a practical point of view, companies needed clarity on what kind of meeting venue was ‘appropriate’ under the Code, and there were related challenges for the sustainability of the conference industry itself. The solution, driven by member companies, was to set up the Conference Vetting System. The initiative proved so successful that the European Federation of Pharmaceutical Industries and Associations (EFPIA) later joined in. 

Once again, the value of having a strong trade association came to the fore. The MedTech Europe Compliance Panel was established to oversee the vetting system, support consistent interpretations of the code, and advise on dispute resolution where necessary. 

Reviewing the Code

The application of the Code, including the Conference Vetting System, was achieved step by step – but it was, nonetheless, a radical change when viewed from a distance. A key element to its success was the willingness to adapt based on companies’ real-world experience of implementing it. This led to a detailed revision of the document, which strengthened the rules, increased transparency, banned direct sponsorship of physicians, and revamped complaint procedures. 

The Code has, since the beginning, included a comprehensive and evolving Question & Answer section, which is informed by the kinds of complex cases users face when operating the Code. It shows the pragmatic nature of the document and reflects a willingness to respond to challenges raised by member companies. 

Indeed, continuous adaptation is a key feature of the Code. Our industry never stands still, so the guidance must constantly adapt. Looking ahead, there is still room for improvement in how data on educational grants is collected and shared, as well as potential for deepening the impact of this MedTech Europe initiative. 

Trade associations in the Middle East, Africa and North America have taken inspiration from our experience, and the MedTech Europe Code has facilitated further alignment on key ethics and compliance matters. This is an illustration of our success in setting the highest standards of self-regulation. 

Another key area of growth is our collaboration with the pharmaceutical industry. The CVS offers an excellent example of how we can work together in this area, and work is already ongoing to strengthen our partnership in compliance. In an industry as innovative and diverse as the life sciences sector, there is real value in establishing common approaches to ethical business practices. 

Our industry is global. Our companies are multinational. The lines between sectors are less distinct than in the past, with some new products combining devices, drugs, diagnostic or digital elements into a single technology.  

Have your say

Ten years since the formal adoption of the MedTech Code of Ethical Business, there is much to be proud of. A key lesson of this success is the willingness to listen to colleagues and partners on how we can continuously improve the Code. That’s where you come in. We will shortly begin seeking input to guide the next evolution of the document, aiming to ensure its continued relevance. We welcome your input as we prepare to look ahead to the next decade.