Pharma and medical device makers have a ‘conflict of interest’ over health education funding
By Chris Wheal
April 25, 2024
Does the sponsorship of healthcare staff influence their purchasing decisions? (image created for illustrative purposes).
A leading Irish healthcare researcher has called for tougher rules on medical device firms funding hospitals. He has alleged there is a potential conflict of interest with firms funding the education costs and salaries of the people who then buy kit from their sponsor firms.
James Larkin is from one of the world’s top medical universities, RCSI in Dublin. He told PharmLifeScience that proposed Irish legislation on transparency of payments from pharma firms and medical device makers was only a start.
There needs to be tougher rules EU-wide to stop the conflicts of interest the payments create – and the UK will need its own laws.
MedTech Europe’s database questioned
Larkin is a postdoctoral researcher focusing on pharmacy and biomolecular sciences in the Department of General Practice at the Royal College of Surgeons in Ireland (RCSI).
He was one of an international team of researchers that examined the payments admitted by medical device makers. The research, published in journal Health Policy and Technology, found that from 2017 to 2019, 116 medical device companies disclosed more than €425m in payments.
But Larkin said less than 10% of UK medical device makers submit figures to the Transparent MedTech database run by medical device trade body MedTech Europe. The Irish figure wasn’t known.
MedTech Europe dismissed the claims. It told PharmaLifeScience: “Our members have a statutory obligation to comply with our Code of Ethical Business Practice. The code, spanning 80 pages and supplemented by additional guidance documents such as the transparency guidelines, serves as a robust framework for navigating interactions between healthcare professionals, organisations, and the medical technology industry.
“It includes a rigorous complaint-handling mechanism, complete with sanctions and governance bodies dedicated to interpreting and upholding the code.
“The code and the different projects and tools that we have created around it (like the Conference Vetting System) have been recognised internationally as a driver for more ethical interactions between medical technology manufacturers and healthcare professionals and organisations. It has been mentioned by the OECD in their anti-corruption forum and in funding for implementation projects by the World Bank.”
The trade body said there had been a significant shift since 2015. This included industry funding of medical education, and in particular industry support for healthcare professionals attending third-party-organised conferences. “The 2015 Code has been taken as inspiration for other codes around the world since its adoption,” MedTech Europe said.
Missing payments
The researchers’ report said: “A small number of medical device companies accounted for the vast majority of these payments and most payments were to healthcare organisations in a small number of countries. Ten countries accounted for 94% of all payments and 10 companies accounted for 80% of all payments.
The top 10 donors, with percentage of total spend, were:
- Johnson & Johnson Medical 43.3%
- Abbott Laboratories 10.4%
- Boston Scientific 7.9%
- Medtronic International Trading 5.8%
- Baxter 3.8%
- Carl Zeiss Meditec Iberia 1.9%
- Smith & Nephew Orthopaedics 1.8%
- Roche 1.8%
- Biotronik 1.8%
- Zimmer 1.7%
Some donated in several countries, while others donated only in one country.
The research reported: “The database itself was rated as having a range of significant shortcomings, such as the limited breadth of recipients, donors and payment areas covered.
Widespread coverage
MedTech Europe claims it has 142 full corporate members, mostly larger companies and, it says, that includes the majority of the larger companies in the market. It has 40 full national association members, which represent thousands of smaller and medium enterprises across Europe. A spokesperson told PharmaLifeScience: “The obligations included in the code are widespread in the medical technology market in terms of market coverage.”
The Health Policy and Technology report said: “Some other important types of payments, such as payments for consultancy, are not included. The accessibility, availability and quality of the database rated low for six measures, medium for six measures, and high for three measures.”
The researchers said similar studies into payment from pharmaceutical firms had found “mis-labelling of recipients, incorrect inclusion of certain recipients such as patient organisations, and anonymisation of some recipients”.
MedTech Europe responded saying: “While the process of collecting, processing and uploading data is intricate and demanding, our members are committed to accuracy. Despite the significant volume of declarations since 2017, we have confidence in the minimal occurrence of errors.
“Our member companies diligently identify and rectify any discrepancies, ensuring the integrity of the data. Their unwavering dedication underscores their commitment to providing transparent and accurate insights into their support for medical education in Europe.”
Transparency legislation
Portugal, France, Belgium, the Netherlands and, most recently, Italy have transparency rules in place. Ireland’s legislation is at the second reading stage. The UK consulted on it and, despite criticism, chose to leave the matter to self-regulation.
But Larkin warned: “Transparency is only the first step. The next step is to consider what is a healthy relationship and what is a conflict of interest. A lot of the donations are inherently problematic. Can a hospital make an independent choice of what devices to buy if one company is funding their education and paying the salaries of key staff?”
MedTech Europe said conflicts of interest were covered. “Industry support for medical education transitioned from a direct sponsorship model, where companies individually selected and invited healthcare professionals to attend educational events, to an indirect model.
“In this new approach, companies provide educational grants to independent entities and institutions. These entities autonomously select the final beneficiaries of the funds, ensuring a more transparent and impartial allocation process.”
This resulted in setting up the Transparent MedTech database, starting in 2017, and demanding mandatory reporting to it.
A statement from MedTech Europe sent to PhamaLifeScience, said: “The code addresses conflicts of interest, among many other ways, by mandating the disclosure of all transfers of value related to educational grants through Transparent MedTech. These transfers encompass both monetary contributions and in-kind grants, with the code providing clear definitions and comprehensive Q&A resources for interpretation.”
Larkin said more needed to be done: “Transparency is being taken more seriously, but restricting some of these relationships is what is needed.”
That goes beyond the research report, which concludes: “There is a large amount of education-related payments from medical device companies to European healthcare organisations, creating substantial potential for conflicts of interest. MedTech Europe's disclosure system has many shortcomings. A European-wide publicly mandated disclosure system for both the medical device and pharmaceutical industries should be introduced.”
Industry response
MedTech Europe told PharmaLifeScience: “In addition to the interactions captured in Transparent MedTech, medical technology companies engage with healthcare professionals and organisations in various legitimate capacities. These interactions include collaborating in research projects, product training sessions, public health communications, and soliciting feedback to enhance product development.
“While these interactions fall outside the scope of our transparency platform, it's essential to recognise their significance in advancing medical technology.”
Close collaboration between medical device makers and healthcare professionals is good for patients, MedTech Europe claims. “Transparent MedTech was designed to provide transparency specifically in the area of industry-funded medical education, aligning with the pivotal changes introduced by our code.
“However, many other interactions, such as consultancy contracts and participation in advisory boards, play a crucial role in product development and ensuring the safe and effective use of medical technology. Patients benefit from these interactions daily, as they contribute to the continual improvement and innovation of medical devices,” a spokesperson said.
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