compliance

According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in the industry and in notified bodies. Looking more closely at medical device startups around the world, more often than not, in my experience, they have taken substantial steps to design a device or software before properly taking regulations into account. Some have determined that their product is not a medical device when in fact, it is (or vice versa). Sending those startups back to the drawing table to modify their device and procedures accordingly is tragic, especially when one can see the benefits the technology would bring for patients. Those startups face the costly and time-consuming endeavor of redesigning the device, and with it, a high potential of failure. However, diligence with regulations would have helped inform right choices from the start. To me, the issue goes back to the time before seed funding of a startup, to the level of regulatory knowledge among its founders and investors. They may have great prospects with future clients, but as long as regulatory issues are not properly considered, a major risk for the business looms. An encouraging example from Finland suggests that venture capitalists have a growing interest in learning the regulatory basics. They have become a notable group of consumers for the regulatory digest (see website in Finnish). This digest has been produced by the Finnish Funding Agency for Innovation (Tekes) with Tom Ståhlberg of Healthtech Finland providing the contents. It is specifically designed to raise awareness concerning regulatory compliance and help medical device stakeholders take...
Following on the footsteps of our American colleagues , MedTech Europe would like to offer some thoughts on the issue of transparency and disclosure laws and how certain adaptations could help to frame transparency for a new reality. Over the last few years, a number of European countries have passed transparency or disclosure (sometimes also called “Sunshine”) laws which require life science industry to track and publicly report certain payments and transfers of value made to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs) such as hospitals or medical societies. The objective of such laws is to provide patients with enhanced transparency into the relationships healthcare providers have with life science manufacturers, including medical technology companies (1) . The new MedTech Europe Code of Ethical Business Practice upholds the same objective while addressing the fragmentation created by the different national rules. More importantly, the Code goes a step further. Let us explain: the Code which entered into force this January introduces several important changes to the way the medical technology industry interacts with HCPs. One key aspect is the prohibition for our member companies to directly support HCPs to attend Third Party Organised Educational Conferences (e.g. paying for the registration fee, travel and lodging). Furthermore, the Code introduces transparency requirements for Educational Grants. They key objective is for companies to stop selecting the HCPs who receive financial support to attend such conferences. This change means that, from 1 January 2018, HCPs’ independent medical education can only be supported via Educational Grants, They will be provided to an independent third-party, such as a hospital or a scientific society, instead of taking the form of direct and unilateral transfers of value to an individual HCP (such as registration fee, travel and lodging costs). Moreover, companies will no longer be involved in the selection...
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...
The MedTech Europe Code of Ethical Business Practice entered into force on the 1 st January 2017, with the phase-out of direct sponsorship that needs to be implemented in less than a year from now. The Code has been the topic of many conversations . However, until recently, we did not have the opinion of individual Healthcare Professionals. Our conversations happened in particular with the organisations representing them. In January, we formally interviewed a sample of Healthcare Professionals coming from different countries. This blog is about sharing the key findings of these interviews. As a background note, most aspects regulated by the Code were already covered by these previous Codes, but there is one fundamental change brought by the new Code that affects Healthcare Professionals. We are of course talking about the change in the model of support to Healthcare Professionals attending Third Party Organised Educational Conferences. The new model requires that a company provides an Educational Grant to a Healthcare Organisation (e.g. medical society, hospital), the latter selecting the Healthcare Professional(s) attending the conference. The Grant covers the costs such as travel, accommodation, and conference registration. The direct selection and support by companies of Healthcare Professionals to attend a given Conference or Congress will not be allowed anymore at the end of this year. The focus of the interviews was about this change. During our discussions with Healthcare Professionals regarding this new model of Educational Grants, one thing became clear; the majority of interviewed Healthcare Professionals were not at all against the change. In fact, a majority welcomed the changes as, according to them, it would bring more legitimacy and transparency. Some Healthcare Professionals also advocated that an independent selection by hospitals was much better than industry selecting HCPs. In their view, hospitals know better who needs training and...