Pharma & MedTech Compliance: Key Updates for 2024 and a Look Ahead to 2025

United Kingdom:

• the long awaited update of the ABPI code was published in September: https://www.dhirubhai.net/posts/gco-global_abpi-code-of-practice-for-the-pharmaceutical-activity-7244609071809531904-jjVc?utm_source=share&utm_medium=member_desktop
• the proposal for a Sunshine act in the UK is still under review but no timeline has been announced yet for its proposal to parliament. We will keep you updated!

Belgium:

• as of the 1st of July brought new hospitality rules and sponsorship clarifications for scientific events: https://www.dhirubhai.net/posts/gco-global_mdeon-news-new-regulations-for-scientific-activity-7217450449354846208-tbFu?utm_source=share&utm_medium=member_desktop

The Netherlands:

• updated its code as of January 2024: 20180107 Dutch_CoC_Pharmaceutical_Advertising ENG per 20180701
• is discussing making Pharma and Med device transparency a legal obligation: Scrutiny on health care professional transparency and inducement in the Netherlands

Germany:

• posted in December about an extension to the scope of the FSA code, to apply to digital health applications (DiGA) as well: : FSA extends codes to Digital Health Applications (DiGA) - Voluntary Self-Regulation for the Pharmaceutical Industry e.V.

EFPIA:

• EFPIA posted a few updates to its meals and drinks scorecard, our post about its most recent one: https://www.dhirubhai.net/posts/gco-global_pharmacompliance-efpia-healthcareprofessional-activity-7247145852777951232-Anx2?utm_source=share&utm_medium=member_desktop

Italy:

• After being enacted, the Italian Sunshine act has not yet entered into force as announced. We will be keeping an eye on that!

Brazil:

• there is an active movement towards making Pharma transparency a legal country wide obligation, with a few bills being proposed. No timeline for enactment is known yet: Global Update on Transparency Reporting: Key Changes and Compliance Guidelines – Policy & Medicine

South Korea:

• has shifted from voluntary to mandatory disclosures in 2024: Global Update on Transparency Reporting: Key Changes and Compliance Guidelines – Policy & Medicine

APAC region:

• the Medical Devices Regional Code was revised and entered into force at the start of 2024 to expand the meaning of the term “Gifts”: Singapore: Revisions to the APACMed Code effective from 1 January 2024 - Baker McKenzie InsightPlus

Outlook for 2025: ?

A transparent relationship with our industry’s stakeholders is key to promote trust and avoid risks. Though many countries still use a voluntary code of practice to promote such disclosures of monetary transactions between industry and stakeholders, there seems to be a stronger push for legally required transparency to become the norm in more and more countries around the world. .

We will be monitoring developments and keeping you updated on our LinkedIn page ?GCO Global: Posts | LinkedIn