This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Distributors play key role in compliance, New industry code must safeguard independent medical education and Health data can transform our lives-but must be used wisely
The Global MedTech Compliance Conference (GMTCC) in Paris, 2-4 May 2018, provided a moment to reflect on how far our industry has travelled on our shared compliance journey, and to consider what we need to do to ensure greater global alignment on codes of ethics.
It is 10 years since the first GMTCC in Paris. Back then, one of our first tasks was to compare and contrast different codes of ethics around the world. We have worked hard to align the principles underpinning the codes applied around the globe ever since.
We have made significant progress on global harmonisation. Nowhere is this better evidenced than in the agreement by the 26-member associations of the Global Medical Technology Alliance to a set of key principles. This huge milestone promises greater convergence within our industry and points the way towards better alignment with the other sectors active in healthcare. (The full announcement could be found here.)
A changed landscape
The world has changed since we first met in Paris a decade ago – and so has our industry. Smartphones had just been launched; mobile health apps were almost unheard of; value-based healthcare was in its infancy.
“As our products and business-models evolve so must our approaches to compliance. This does not mean deviating from the core principles we have signed up to. However, it requires us to update the guidance we give members in order to stay relevant. That is why AdvaMed is refreshing its code to update FAQs, improve usability, and provide new examples of what compliance looks like in today’s world. “, says Ms Bronwen Taylor, Vice President, Compliance & Risk Management, Stryker and chairwoman of the AdvaMed DDCG.
“Meanwhile MedTech Europe is engaging with senior business leaders to ensure that its code is practical and pragmatic; keeping to our principles while taking account of the impact the code has on members and stakeholders,” says Mr Roeland Van Aelst, VP Healthcare Compliance EMEA & Canada, Johnson & Johnson and chairman of the MTE Ethics & Compliance Committee.
Advancements in the healthcare landscape over the past decade have changed how manufacturers interact with stakeholders, including patients, doctors, medical education bodies, regulators, payers and providers. Engaging with this broad spectrum of players is an increasingly important part of modern healthcare. As we move towards an outcome-focused, value-based approach to healthcare, multi-stakeholder dialogue will only become more relevant.
Patient care has evolved from single discrete episodes of care towards a continuum ranging from prevention and diagnostics to intervention and long-term post-intervention management. At the same time, public expectations have changed creating new opportunities and new tensions: maximum transparency is expected while privacy is increasingly valued. Responding to this is a task that will feature in the years ahead.
There are also some region-specific challenges. “In Europe, recasting the medical education model is a pressing issue. Regulators expect companies to equip physicians with the skills needed to use increasingly sophisticated products. At the same time, the need for continuing medical education remains, and new thinking is needed to ensure the sustainability of professional medical education bodies.” adds Van Aelst.
“In the US, it is time to reflect on how transparency has worked in practice. Is the effort involved in collecting and publishing data delivering the value anticipated by regulators? If not, we must work together to devise new ways to achieve our goals.” adds Taylor.
As we continue to strive for greater harmonisation, we will face challenges where there are diverging regulations around transparency reporting. In the US, federal and state laws are not aligned; in Europe, EU Member States – such as France and Portugal – have created diverging legislation.
While there is plenty of work to do in the decade to come, our successful collaboration over the past 10 years makes us confident that we can find shared solutions for our members.