UK Open consultation
Disclosure of industry payments to the healthcare sector
Published 4 September 2023. Deadline for comment 11:59pm on 16 October 2023.
The UK Government is seeking views on the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations. This consultation aims to address the second part of recommendation 8 contained in the IMMDS report, regarding real and perceived conflicts of interest in the health system. Gathering views through the consultation is an important step in the development of policies in this area. The Government welcome responses from any interested person, business or organisation. The easiest way to respond is by completing the online survey.
If you are unable to use the online form, email industry-reporting-consultation@dhsc.gov.uk. Do not send any personal information to this email address.
https://www.gov.uk/government/consultations/the-disclosure-of-industry-payments-to-the-healthcare-sector/disclosure-of-industry-payments-to-the-healthcare-sector
Response from, Selda Ulucanlar, Department for Health, University of Bath, Alice Fabbri, Department for Health, University of Bath, Melissa Mialon, Trinity College Dublin, Kathrin Lauber, School of Social and Political Science, University of Edinburgh, Viroj Tangcharoensathien, International Health Policy Program, Thailand
Introduction to our response and why this consultation is relevant to our work
Baby Milk Action/IBFAN UK, is the UK member of the International Baby Food Action Network (IBFAN) a network of over 300 citizens groups in more than 100 countries that was founded in 1979. Since then, IBFAN has worked in collaboration with WHO and UNICEF and civil society partners to improve maternal and infant and young child health through the protection, support and promotion of breastfeeding and optimal complementary feeding. We have helped many governments bring in legislation to control harmful marketing, based on the global recommendations adopted at the World Health Assembly in 1981, namely the International Code of Marketing of Breastmilk Substitutes. We have also helped governments adopt WHA Resolutions that keep pace with science and marketing developments. There are now 20 Resolutions and Decisions that clarify and strengthen the 1981 Code, alongside the Convention on the Rights of the Child adopted in 1989.[1]
Breastfeeding constitutes one of the single most effective ways to reduce inequalities, to fulfil the child’s right to life and to the enjoyment of the highest attainable standard of health. The International Code and Resolutions are designed to ensure that all parents receive objective and truly independent information, to remove obstacles to breastfeeding and ensure that breastmilk substitutes are used appropriately. Addressing Conflicts of Interest and ensuring that health policy setting is protected from undue commercial influence has been and continues to be a cross-cutting and critically important aspect of IBFAN’s advocacy.
Baby Milk Action founded the Baby Feeding Law Group (BFLG) in 1997, the year after the adoption of the World Health Assembly Resolution 49.15, the first of several Resolutions calling for Conflict of Interest safeguards in matters relating to Infant and Young Child Feeding and monitoring.[2] The aim of the BFLG has been to bring UK and EU legislation into line with WHA Resolutions and Recommendations to protect maternal and child health in the UK and globally, including in LMICs where UK policies have impact.
Transparency and the establishment of the European Food Safety Authority (EFSA). As part of our continuing efforts to bring in and strengthen European legislation to protect child health, in 2000, IBFAN (backed by the BFLG and many health NGOs) helped expose the lack of transparency and conflicts of interest in the EU’s Scientific Committee for Food (SCF). Poor SCF advice had, for many years, led to serious loopholes in EU legislation and the adoption in 1999 of the seriously problematic Directive on Foods for Special Medical Purposes.[3] The SCF was subsequently closed down and replaced by the European Food Safety Authority (EFSA) whose new Conflict of Interest rules aimed to keep the agency at arms length from the commercial and political process. IBFAN was consulted by the EU Commission regarding the formation of the transparency and COI rules and some of our suggestions were taken up.[4],[5]
In later years the Commission acknowledged that the FSMP Directive had caused problems: “Over the past years, Member States’ national competent authorities have reported increasing difficulties with the enforcement of the legislative framework applicable to FSMP. Member States’ experts have in particular flagged that an increasing number of products are placed on the market as FSMP in their territory, but that doubts arise in certain cases as to whether the products really correspond to the definition of FSMP and therefore correctly fall within the scope of the FSMP legislation.” [6]
In our experience the influence of commercial funding on UK, EU and global policy setting is profound and grossly under-estimated and is an important justification for regulation in this area. [7] With this in mind we consider that it would be a great mistake for the UK Government to fall back of voluntary/self-regulation, which numerous studies have shown to be not only ineffective, but subversive. Voluntary systems have multiple commercial advantages, especially for transnational corporations with extensive PR budgets, not least because the trustworthy, responsible public image conveyed diverts attention from the harmful practices. Institutions can also perpetuate this problem by adopting weak policies that fail to address serious conflicts of interest that distort /subvert their own policy and practice. While increased transparency is an important first step, for true impartiality of clinical decision-making it is essential that financial conflicts of interest are not only regulated – but when found to be inappropriate – avoided.
IBFAN warmly welcomes this consultation on the possible introduction of new secondary legislation that would place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals. We strongly support the BFLG justification for expanding the scope of businesses covered, and would go further to stress that while especially health-harming commercial entities – can be
[1] The UK has ratified the Convention on the Rights of the Child (CRC) Article 24 of which calls on governments to provide parents with information on nutrition and breastfeeding. The CRC General Comments Nos. 15 and 16 stress the obligation for States to protect, promote and support breastfeeding through the implementation of the World Health Assembly Global Strategy for Infant and Young Child Feeding (GSIYCF) and set a direct obligation that companies abide by the IC and Resolution universally ‘in all contexts’ The International Code and WHA Resolutions are embedded in many global declarations, standards and strategies, including the Codex Code of Ethics,[1] and the UN Political Declaration and Framework for Action.
[2] 1996 WHA Res 49.15: Preambular para: “Concerned that health institutions and ministries may be subject to subtle pressure to accept, inappropriately, financial or other support for professional training in infant and child health” 3.urged Member States:….(2) to ensure that the financial support for professionals working in infant and young child health does not create conflicts of interest, especially with regard to the WHO/UNICEF Baby Friendly Hospital Initiative; (3) to ensure that monitoring the application of the International Code and subsequent relevant resolutions is carried out in a transparent, independent manner, free from commercial influence; Other WHA Resolutions calling for transparency and Conflict of Interest Safeguards: 2002 WHA Res 55.25, 2004 WHA Res 57.17, 2005 WHA Res 58.32: 2012 WHA Res 65.6 2014 WHA Res 67(9) 2016 WHA Res 69/9
[3] COMMISSION DIRECTIVE 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1999L0021:20070119:EN:PDF BFLG Brifing:http://www.babymilkaction.org/wp-content/uploads/2022/06/FSMP-Briefing-Tuesday.pdf
[4] European Voice, Renee Cordes: Clamour for Action to bolster Union Scientists’ credibility, 13-19 Jan 2000, Vol 6, No 2, Scientists bow to call for more transparency., 16-22 March, 2000, Vol 6, No 11.
[5] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
https://www.legislation.gov.uk/eur/2002/178/contents
[6] Commission Notice on the classification of Food for Special Medical Purposes (FSMP) (2017/C 401/01)
[7] Interference in public health policy: examples of how the baby food industry uses tobacco industry tactics, 2017 https://worldnutritionjournal.org/index.php/wn/article/view/155