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.

Any conference, congress or other important event usually involves some kind of a feedback exercise.
The 7th European Healthcare Fraud & Corruption Network conference took place in Brussels at the end of September and featured high level speakers and experts. The event proved to be an ideal platform for discussing a number of topics of relevance to all the stakeholders in the healthcare system. The “Conflicts of Interest” session was very interesting, seeing as how much we, Eucomed and its members, have been investing in creating and developing an ethical culture of integrity and ethical business practices across the medical technology industry. Only then will we be able to manage the inherent conflicts of interest that exist in the relationship between the industry and the healthcare professionals. The discussion centred around four areas where conflicts of interest could arise: Research, trials and publications; The bias in decision making (developing in particular the case study of the H1N1 influenza decision by the WHO); Training and education of healthcare professionals; Gifts. The panel spent quite some time discussing how, in some of these areas, different stakeholders in the healthcare system are biased towards the industry (mostly focused on the pharma industry). A seat at the table Let’s apply one point of the discussion – research, trials and publications - to a recent publication that everyone is currently talking about and which reports that industry sponsored studies are more likely to have outcomes favouring the sponsor compared to studies not sponsored by industry presents several other conclusions which, for some reason, are not so widely quoted. The publication states, for instance, that industry funded research is less likely to be published compared to publications funded by other means. What I would like to illustrate by this is that everyone is biased and certainly not always towards industry. Everyone should, however, have the same opportunities to at least become...
Talking about ethics and compliance as industry understands it within the frame of a course of Health Systems Management given at the Public Health School of the Université Libre de Bruxelles (ULB) presented itself as a challenge. On the one hand, Eucomed is putting a lot of efforts into promoting a culture of integrity and ethical business practices across the medical technology industry, but how to explain Eucomed’s compliance activities to students, mainly physicians, coming from developing countries and having so far taken a more public health approach? In order to make the lecture interesting for the attendees, I figured that the scope of the presentation had to be wider than just the relationship between the industry and the Healthcare Professionals – which is the focus on Eucomed’s ethical guidelines and activities – and therefore focused the discussion on corruption in the healthcare system at large and the push that we see in Europe and the US to transparency, accountability and ethical governance. I tried to contextualise ethics and compliance as industry understands it and put it in a broader perspective. Indeed there are many stakeholders in the healthcare system and the potential for abuse and corruption exists in each one of the relationships. What I tried to illustrate by this chart is that the list of possible abuses by the different stakeholders is very long. There are informal payments, theft, illegal referral arrangements, inducement of unnecessary medical procedures, bribery of inspectors to overlook compliance, identity fraud (by the patients), abuses in the procurement of supplies by the providers (e.g. hospitals, health facilities) such as the overpayment of goods and services or substitution of lower-quality products (by suppliers). There are several consequences linked to corruption, on the economy at large, on businesses, on the healthcare system – it is estimated...
The EPC organised on May 6th a policy dialogue with the World Bank on the topic: "Russia in the global economic storm" and presented its latest Economic Report dated March 2009 and available here . The numbers of the World Bank, even though considered by the key note as "educated guesses" are still the best available data. The main message of the discussions was that the next few years for Russia look grim and one aspect that was discussed was that this already strongly impacts the social situation of Russian citizens. The healthcare aspect was not touched upon specifically during this debate, but one of the Eucomed working groups is looking at the impact of the financial crisis on the Eastern European countries including Russia. At present, the group is working on a workshop which will take place on October 6th in Brussels at the MedTech Forum to discuss growth and opportunities in those countries with regional experts (more details available soon). The group was interested in the fact that in 2006, the Russian government decided to reform its healthcare system with a shift towards quality through the revenues coming from the oil business. On the other hand, out-of-pocket expenses and under the table bribes have increased dramatically over the past few years and with the crisis increasing the vulnerability to poverty of Russian households, it can be expected that the inability of less healthy people to pay unofficially for care will increase. From a healthcare system point of view, if we assume that co-payments can be used as an index of countries' underdevelopment, the structural reforms recommended by the World Bank in the above mentioned report to modernise the country, will therefore also have to think about the financing of the healthcare system. This system today is un-competitive and...
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