{"id":44692,"date":"2019-05-24T12:13:40","date_gmt":"2019-05-24T11:13:40","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=44692"},"modified":"2019-05-31T11:18:09","modified_gmt":"2019-05-31T10:18:09","slug":"kaisa-immonen-industry-links-with-patient-organisations-transparency-is-fundamental","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/24\/kaisa-immonen-industry-links-with-patient-organisations-transparency-is-fundamental\/","title":{"rendered":"Kaisa Immonen: Industry links with patient organisations\u2014transparency is fundamental"},"content":{"rendered":"

Transparency has tended to be approached in a defensive manner, but it should instead be seen as an opportunity, says Kaisa Immonen<\/p>\n

\"\"The relationships between patient organisations and the pharmaceutical industry have been the subject of recent studies<\/a> and accompanying debates<\/a> in this journal.<\/span> A new analysis by Ozieranski and colleagues<\/a> adds nothing unexpected to this debate. It does confirm, however, that there is a real trust gap around patient organisations\u2019 links with industry.<\/span> This has potentially serious implications for the credibility of patient organisations as partners in medicines regulation.<\/span><\/p>\n

Patient organisations have a legitimate interest in cooperating with pharmaceutical companies in their quest for new and better treatments. Patients\u2019 involvement in pharmaceutical research is an area of growing interest, as companies increasingly aim to become more \u201cpatient centred.\u201d Regulators and health technology assessment (HTA) bodies, too, recognise the importance of patient evidence stemming from experiential knowledge, though in practice advances are patchy. Progress should not be undermined by lack of trust. <\/span><\/p>\n

It is of the utmost importance that medicines regulation, whether at EU or national level, is rigorous, transparent, and unbiased\u2014even more so as public, private, and non-profit organisations are increasingly working collaboratively in pharmaceutical research, making it difficult to avoid all potential conflicts. This is especially evident in rare diseases, where expertise is by definition scarce and experts tend to all know and work with one another. Having a \u201cpure\u201d regulatory process is a noble idea, but unrealistic. <\/span><\/p>\n

Need for better criteria and robust procedures<\/strong><\/p>\n

Industry links should be more carefully reported by everyone involved in regulatory and HTA processes. Patients, patient organisations, and others such as medical professionals should all be held to the same high standard of transparency and ethical behaviour<\/a>.<\/span> This does not mean that patient organisations that accept industry funding should be <\/span>a priori<\/span><\/i> excluded from the entire process. Having no patient perspective at all is unlikely to improve the quality of the outcome<\/a>.<\/span><\/p>\n

Robust procedures should be in place to manage interests, avoid conflicts, and ensure unbiased outcomes. The criteria on what to report must be clearly communicated. From a European perspective, closer alignment of transparency requirements and conflict of interest criteria in national regulatory pathways with those of the European Medicines Agency<\/a> would bring welcome clarity for patient organisations, but surely also for other stakeholders.<\/span> In HTA, there is currently no consensus about what constitutes \u201cbest practice,\u201d but the topic is a growing concern<\/a>.<\/span><\/p>\n

What can patient organisations do? <\/strong><\/p>\n

Good governance, including financial governance and transparency, should be a fundamental principle and practice of any serious patient organisation. It is true that many patient organisations are small and function on a largely voluntary basis; following best practice in transparency may not be on their list of immediate priorities. It should be\u2014or other achievements may be seriously undermined. There is no room for complacency. <\/span><\/p>\n

Codes of conduct<\/a> and guidelines<\/a> have been developed by patient organisations<\/a> as well as others and are available for a variety of topics, from ethical fundraising and working with funders, to transparency and ethical conduct.<\/span> However, currently these are not all consistent or mandatory. Recently, the European Patients\u2019 Forum, an EU level umbrella organisation representing patient organisations across diseases, developed a guideline specifically focusing on transparency<\/a>, in a response to an expressed need from its members. The aim of the guideline is to encourage patient organisations to think of transparency as a fundamental aspect of running an ethically sound NGO and to support concrete improvements by showing good practices as well as potential pitfalls. The guideline is available as a free resource<\/a> for any NGO.<\/span><\/p>\n

Transparency has tended to be approached in a defensive manner, i.e. as something that \u201cmust\u201d be improved for fear of bad reputation. It should instead be seen as an opportunity: there is much to gain by proactively working towards higher standards of transparency across all our activities: credibility, trust, greater visibility, and a better understanding of our work.<\/span><\/p>\n

Patient organisations should be able to demonstrate through their work that their positions represent the real interests of patients, independently of who provides their funding. We must show integrity, independent critical thinking, and a healthy scepticism that keeps us at the right distance from those who fund us\u2014whether it is a government or pharma sponsors.<\/span><\/p>\n

Is it fair to continually put the spotlight on patient organisations in this way? Maybe not. The same standards should apply to others, too. But the reality is, like it or not, that patient organisations\u2019 credibility will always be under particular scrutiny. Credibility is, ultimately, what we stand or fall down on. There is a clear need for sustainable, ethical funding solutions to enable patient groups to function and contribute meaningfully to medicines research, regulation, and evaluation. While we work collectively with industry and other stakeholders towards finding such solutions, we need to also make sure that our credibility stands up to scrutiny. \u00a0\u00a0<\/span><\/p>\n

Kaisa Immonen<\/strong> is director of policy at the European Patients\u2019 Forum, a cross-disease umbrella organisation with 74 member organisations across the EU, where she leads on policy and advocacy and represents EPF at international fora such as the OECD. She currently holds the patient co-chair of the European Medicines Agency\u2019s Patients and Consumers Working Party. She is also a member of <\/em>The BMJ patient panel in her personal capacity. Twitter @KaisaBxl<\/a><\/em><\/p>\n

Competing interests:<\/strong> I have no personal interests to declare. I am employed by the European Patients’ Forum. EPF accepts funding from a variety of sources, including the pharmaceutical industry. Details of EPF’s funders, funding arrangements, and accounts are available on its website: http:\/\/www.eu-patient.eu\/About-EPF\/Transparency\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Transparency has tended to be approached in a defensive manner, but it should instead be seen as an opportunity, says Kaisa Immonen […]<\/p>\n

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