GMTCC

The Advamed Latin America Compliance Conference and the upcoming Global MedTech Compliance Conference Sometimes I feel that compliance is like a jigsaw puzzle where every new piece brings us closer to the complete picture: Codes of Ethics. After being heavily involved in the adoption of the MedTech Europe Code of Business Ethical Practice , during my time as Legal & Compliance Manager at MedTech Europe, I have been amazed during the AdvaMed Latin America Compliance Conference 2017 by the similarities of debates taking place in Europe and in Latin America. One of my conclusions is that adherence to ethical standards goes beyond borders and supersedes geopolitical considerations to reach common objectives. Held in Bogota in February, key stakeholders coming from Latin America, US and Europe have been discussing worldwide trends that Latin America is also experimenting. Most of the countries (e.g. Mexico, Ecuador, Colombia, Brazil) have adopted Code of Ethics, and some of them (e.g. Colombia, Mexico) have already banned the direct sponsorship of Healthcare Professionals to attend Third Party Organised Events. Other countries are currently considering to: (i) phase out the direct sponsorship (e.g. Brazil); (ii) implement a transparency system (e.g. Colombia) with the same philosophy as the Europe and/or the US framework; (iii) reinforce anti-bribery laws (e.g. Colombia, Brazil, Mexico). Thus, noteworthy initiatives are spreading in Latin America: within a context of public scandals and corruption [1] (e.g. “ Mensalão ”, “ Car wash ”, “ Prosthesis Mafia ” scandals), the Brazilian Association of Medical Technology (ABIMED) created multilateral working groups involving public authorities, Committee of Ethics and medical societies to reinforce their Code of Ethics and to strengthen the prevention, the monitoring and the sanctions applicable to all forms of corruption. I would also point out another key challenge that speakers tried to address: how to involve...
I recently sat down with Peter Blenkinsop , a Partner at DrinkerBiddle , an expert on data privacy and one of the panelists at our upcoming GMTCC Conference (Amsterdam, May 3-4), to get his take on the biggest privacy law challenges currently facing Medtech companies . Peter pointed to two trends that are changing the Medtech sector and provided insight on how privacy and data protection laws may impact those trends: Trend #1: Rapid growth of consumer generated and controlled health and wellness data Consumers now have an ever-increasing number of options for tracking their health and wellness between visits to the doctor. Mobile apps that enable consumers to monitor and manage their health are extremely popular. These apps allow consumers to track, share and utilize insights from data in a variety of ways and can be integrated with other systems including medical devices and electronic health records. This has resulted in an explosion of consumer health data that could be put to many beneficial uses. For example, researchers could harness this data collection for a particular person and ‘go back in time’ after a patient experiences a serious medical event to better understand what signals were present that may have foreshadowed the event. They could then leverage those learnings to alert similar individuals in the future who exhibited the same signs, perhaps averting a medical emergency. The accessibility of such data to researchers in the first place hinges on one thing: trust . If consumers don’t trust app and device makers to use their data appropriately, then they won’t share it. Trend #2: Increasing demand for health outcomes and cost-effectiveness information Now, more than ever, payers want real-world evidence of the value of medical technologies they have agreed to cover. This requires the collection of data on comparative health...
Each fall the two of us meet to discuss global healthcare legal and compliance developments and to assess implications on the medical technology industry, patient care and innovation. When we first began collaborating the iPhone was just invented (healthcare apps were unimaginable) and, since that time, quite a bit has changed! When we annually meet, we reflect on member company input and surveys, leading health official statements and policies, medical professional societies and patient perspectives, business trends, and developments in other industries - a 360 degree review! From transparency to FCPA to the phase out of direct sponsorship we've analysed most developments shaping this field and tried to position our industry ahead of the curve when we could. The Global MedTech Compliance Conference , GMTCC in short, is our annual forum for global medtech compliance and ethics exchange on the trends and topics we see as most pressing to patients, industry and users. This is our industry’s opportunity to learn from each other, from thought leaders, and to continuously advance our work, just as our industry continuously drives ahead new patient care innovations. As an industry and legal/compliance experts we've achieved remarkable success - new guidance, distributor trainings, outreach to important stakeholders, including also international organisations such as OECD, small company boot camp, etc. - and our annual GMTCC dialogue among global leadership has been instrumental to this success. In past years we've focused on new law enforcement theories and assessed how we can lead industry to safety, preserve industry innovation and establish credible self-regulatory approaches through ethics and compliance guidance. When possible, we've tried to align our policy work to avoid regional fragmentation for a global industry dependent on global lines of scientific exchange. But, when we met last fall, and we again reflected on developments, trends, thought leader...