Aline Lautenberg

Aline Lautenberg is the Eucomed, EDMA and MedTech Europe Legal Counsel. She joined Eucomed in February 2004, as Economic and Legal Affairs manager, after having worked as a consultant for over two years for a consultancy specialised in reimbursement of medical technologies. Since May 2013, she is also responsible for EMDA and MedTech Europe's legal and compliance matters.Aline is responsible for advising on the three organisations' contractual, regulatory and statutory obligations and assisting the Eucomed, EDMA and MedTech Europe Chief Executive and the respective Boards of Directors in management decision processes with robust risk assessments within the framework of the Eucomed, EDMA and MedTech Europe strategies. Moreover, Aline supports Eucomed and EDMA members on all legal, ethics and healthcare compliance issues. This includes the overall planning and management of legal and compliance groups and activities of the three organisations.Aline has a Master's Degree in Law from the University of Louvain-la-Neuve in Belgium, and has been a member of the Belgian "Institut des juristes d'entreprise" (IJE) since 2009. A Swiss and German national, she speaks fluent English, German and French, and has a good knowledge of Italian and a basic understanding of Greek.

If the activities of the medical technology industry are viewed through the prism of either corruption or honesty, then the draft MedTech Europe Code of Ethical Business Practice could be considered as an endeavor to dissociate the industry from the former. The draft code does so by providing a clear and stringent framework, ensuring that the industry behaves in all its interactions with healthcare professionals (HCPs) in such a way that it safeguards its image and reputation. It has taken almost two years to write this new common MedTech Europe Code, discussing every point, fine-tuning every detail and eventually reaching a consensus on how each aspect of our industry’s interaction with HCPs should be regulated. Now that we are fast approaching the moment of choice, i.e. when the MedTech industry will be asked to vote “YES” or “NO” to the proposed text, I often get asked whether I think the new Code will be approved. I do not hold a crystal ball and therefore cannot predict the outcome of a democratic vote. But whether the new Code is approved or not, there are a few points I believe are worth noting: • The narrow scope of the debate: discussions have mostly focused on the so-called phase-out of direct sponsorship of HCPs to third-party organised conferences, disregarding the already existing and very-well established alternative, and by this I mean supporting independent medical education via educational grants. This debate also misses the fact that the revision of the respective EDMA and Eucomed Codes of Ethical Business Practice into a single MedTech Europe Code touches upon every single aspect of the relationship between the MedTech industry and healthcare professionals. Financial support of HCPs to third-party organised conferences is only a small part of the new Code. Yet, it gets all the attention. •...
In 2008 Eucomed published its revised Code of Ethical Business Practice. We’re six years on now and we’re thinking about writing a new one. Why? Because so much has changed in the world of medtech 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.
Transparency
In October last year, Eucomed published a press release to introduce to its broader membership and stakeholders the launch of a new “Conference vetting system” in 2012. Aimed to simplify decision-making for Eucomed members by providing clear approvals on sponsorship of events, this unique initiative in our industry has already interested the media, including an article in the Financial Times.
Eucomed published on 23 December 2010 its first Compliance Panel recommendation on the sponsorship of third party educational conferences by Eucomed members . The Panel, an independent body of three external opinion leading experts, was appointed to help provide guidance on the interpretation of the Eucomed Code of Ethical Business Practice as well as drive European harmonisation with respect to Code implementation and comprehension. With this publication, the Panel has outlined in detail six objectives that must be met in order to be compliant with the Eucomed Code, as far as the sponsoring of a congress is concerned. The decision by Eucomed to request the Panel for such a recommendation was triggered by a number of requests by both Eucomed members, and professional congress organisers (PCO’s) about sponsorship invitations regarding third-party congresses and conferences. It is worthwhile noting that the sponsoring of congresses has become a rather large and time-consuming part of the compliance activities for Eucomed and for its members, mainly due to the inherent conflict of interest when industry is directly sponsoring the [general] education of physicians. This issue can potentially be addressed by changing the code and putting an end to the direct sponsorship of Healthcare Professionals (HCPs) to congresses, but this is a major policy shift. The US model, where sponsorship of HCPs to congresses is financed through grants provided to the conference sponsor (i.e. no direct sponsorship of HCPs by industry) cannot be merely copied over, and thus, as a group, we will have to carefully consider our options and time our strategy properly as well as discuss it with other stakeholders. The Compliance Panel was created in March 2010, primarily to help to ensure the adherence to the Eucomed Code by all members of Eucomed as well as drive European harmonisation with respect to...
Any conference, congress or other important event usually involves some kind of a feedback exercise.