Ethics and compliance in the MedTech industry: on the agenda in Stockholm

  • Posted on 26.04.2012

Ethics and compliance in the MedTech industry: on the agenda in Stockholm


Aline Lautenberg

MedTech Europe, General Counsel - Director Legal & Compliance


For medtech companies, interacting with Healthcare Professionals (HCPs) is a fact of life. HCPs are an integral part of the R&D process and a source of innovation and creativity throughout the development of medical devices. HCPs are also the prime users of technologies and play an instrumental role in the successful adoption of innovative medical devices in Europe, the US and beyond. With the adoption of new anti-bribery laws in a number of countries, increasing enforcement and new pressures from investors and the general public, the International Medical Device Industry Compliance Conference on 9-11 May in Stockholm, is well-timed to provide a platform for stakeholders to discuss these mounting challenges.

Since its inception, the event has served as a breeding ground for new thinking in ethics and compliance, marked by useful presentations and varied perspectives.

Thinking back, there were several key public interventions which may be branded into compliance officers and company lawyers’ minds. One example for me is the intervention of Kate Hamann  of the US Department of Justice (DOJ), who explained in 2010 what the U.S. Securities and Exchange Commission (SEC) and DOJ expect from the medtech industry. In particular, she highlighted industry risks with regards to business relationships with third parties, explaining that companies will be held liable under the Foreign Corrupt Practices Act for the activities of their distributors.

Eucomed and AdvaMed seized this opportunity to work closely together in the last year to draft guidance to support our member companies and assist them with compliance issues relating to their Third-Party Sales and Marketing Intermediary (SMI) Relationships.

We hope to build on this initiative at this year’s conference, with more in-depth discussions on what tools can be developed to aid company compliance officers in addressing this particular risk. Actual distributors will also be on hand to share their perspectives on the requirements imposed on them by companies.

Discussions at previous editions on the need for ethical behaviour in conference sponsorships, also played a role in the conception of the Ethical MedTech Conference Vetting System, which recently launched in a pilot phase.

But this is not all. Many other topics are on the agenda including what might be as “Sunshine”, “Transparency” or the requirements for companies to disclose publicly payments made to individual HCPs, which is slowly but surely making its way through Europe and other parts of the world (e.g. Japan). Which countries are already affected? Who’s next? What do we do? What can we do?

AdvaMed and Eucomed have worked hard make this conference the best yet, with more interaction (through the conference smartphone app) and a stronger focus on stakeholder engagement. We have already surpassed previous registration numbers, with an unprecedented number of international attendees from the US, Europe, Latin America and Asia joining us to hear from CEOs and leaders in compliance.

– Aline Lautenberg, Senior Legal Counsel, Eucomed

– Christopher White, General Counsel, AdvaMed

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