A pdf version of the following letter can be accessed here on the Scottish parliament website.
Sunday, 15 March 2015
To: Public Petitions Committee
The Scottish Parliament
Dear Public Petitions Committee
Scottish Parliament Public Petition PE1493 on a Sunshine Act for Scotland
Thank you for informing me that my petition is to be considered by the Public Petitions Committee at its meeting on Tuesday 31st March 2015.
You suggested that I might like to make a written submission for the meeting of the Committee informing me that this would be published online with the other evidence that the Committee have gathered for Petition PE1493. Since my last submission to the committee I have received a letter from the Scottish Government dated 24th February 2015 [included below] which asks my views as petitioner on a number of specific matters. With the permission of Gordon Clark, Scottish Government, I thought it would be sensible to offer my views in a single letter copied to all.
My preference has always been to keep letters to the committee to one page, but unfortunately on this occasion, given the number of questions asked by the Scottish Government, this letter requires to be longer. I will begin this letter with a current summary of my position as petitioner for a Sunshine Act and then, in the second half of my letter, do my best to answer the questions asked by the Scottish Government.
My summary position as petitioner for a Sunshine Act:
Gathering evidence and necessary research to support this petition has led me to conclude that the pharmaceutical industry has had significant control within Scotland’s health sector and that this has been met with very little opposition or even analysis.
Open and transparent from omphalos on Vimeo.
The Scottish Government has since confirmed that across Scotland its own guidance, HDL 62, has been widely ignored.
The Scottish Government position states that we should consider “existing legislation”.
The Scottish Government are of the view that we have two safeguards: (1) professional bodies and (2) “the significant progress towards voluntary registers by the pharmaceutical industry.”
Considering these in turn:
Firstly, regarding professional and regulatory bodies:
Niall Dickson, the Chief Executive Officer for the General Medical Council (GMC), the professional regulatory body for doctors, has recently stated that “Parliament has not given us powers”. This was the official GMC response to Fiona Godlee, Editor in Chief of the BMJ who stated in her recent BMJ editorial that “the profession must take the lead to protect patients and maintain public trust. The GMC should act, and a public register of UK doctors’ financial interests is long overdue.”
I have been in communication with the Royal College of Psychiatrists, the additional “regulatory body” of which I am a member. This recent communication, with the Royal College of Psychiatrists, relevant to this petition, can be read here. In summary the Royal College of Psychiatrists guidance again refers to local registers, as in HDL 62, which we know are not being maintained.
Secondly, the “significant progress towards voluntary registers by the pharmaceutical industry.” (Scot Gov statement)
It is the case that the Association of British Pharmaceutical Industries (ABPI) have led on setting up what they have termed as a “Central Platform”. From 2016, this platform will gather individual payments and record these in an open, central, searchable database. However, it is the case that any healthcare professional can opt-out of any disclosure of any financial payments made to them on this platform.
The Scottish Government, in a letter to me dated 24th February 2015, [see annexe] asked my views as petitioner on nine separate points. What follows are my responses as given under each Scottish Government question:
(1) Is your primary concern around ensuring appropriate prescribing?
This is my primary concern.
This is a longstanding concern based on the ethical principle primum non nocere “above all first do no harm”. My view, as petitioner, is that appropriate prescribing must try to achieve maximum benefit and minimum harm: a ratio crucial at both individual and population level. Evidence has repeatedly revealed that harm and/or risks associated with prescribing may emerge only after the pharmaceutical industry has made its money. My view, as petitioner, is that “appropriate prescribing” in Scotland should follow evidence-based science that is free from financial conflicts of interest. Prescribing should be based upon scientific objectivity alone. Prescribing should not be determined by market forces.
One of my original motivations for raising this petition for a Sunshine Act was an appreciation that pharmaceutical companies use paid speakers, consultants and researchers to promote the off-label use of drugs in Scotland:
This is just one example of evidence that this happening. I covered a range of other examples in my original submission to the committee:
(2) Who should have responsibility for keeping and updating information on payments (including payments in kind) received?
I would like to see an independent body that is set up to maintain a central, single, open, searchable register that is updated on a planned and scheduled basis and which is tied to professional accountability and governance. Such a register should include not just doctors, but pharmacists, academics, nurses, allied health professionals and indeed advisors to charities.
(3) What should happen in the event of non-compliance?
It is my view that any system that is developed to replace HDL 62 must include meaningful sanctions to be used in the event of non-compliance. There is always the potential for litigation following any harms caused.
From a practical point of view, enforcement would be likely to involve a number of different approaches. Failure to follow legislation may involve regulatory bodies. For example, in the case of doctors this would be with the General Medical Council.
“Non compliance” also has a dimension that may be beyond the employed individual. At least two NHS Boards in Scotland, NHS Lothian and NHS Forth Valley, have confirmed that they have zero budget to support medical education. The financial support of this education is thus solely through commercial arrangements. The details of this are covered here.
(4) Which professions and groups should be covered?
This should include not just doctors (both at primary and secondary care), but also pharmacists, nurses, academics, allied health professionals and indeed advisors to charities. It should also apply to any commissioners of healthcare services in Scotland including all those involved in improvement work.
As petitioner, part of my research confirmed in November 2013 that 44 separate Scottish Intercollegiate Guidelines (SIGN) guidelines had no records of declarations of interest. This concerns me greatly as does the limited governance of the experts involved in the Scottish Medicines Consortium.
(5) Who/what should be covered by the terms ‘industry and commerce’?
The approach taken in France to legislation appears to be a reasonable model. The USA has also introduced Sunshine legislation. As petitioner, I would suggest that there is much to be learned from the approaches taken in France and the USA.
“Industry and commerce” might include: the pharmaceutical industry; device and implement manufacturers; and commercial enterprises involved in diagnostics, nutritional supplements and digital technologies. As petitioner, I would also suggest that academics, patient groups and charities are included. In France, disclosure of financial support to patient organisations has been a legal obligation since 2009.
(6) Should there be a threshold for providing information on payments (including payments in kind) and if so what should that be?
I think this a matter that should be open to consultation. I would suggest a similar framework to that used by this voluntary database:
(7) If registers of payments (including payments in kind) were established what should the status of these registers be?
A national register requires legislation to be put in place to make it meaningful, robust and properly transparent. Timescales for submissions would be clearly defined. This register should be open to all with a link placed obviously on each NHS Board homepage.
All medical educational conferences held in Scotland should have a homepage link to this single, open, searchable database. Thus duplication of recording would no longer be an issue.
(8) Do you have experience of concerns raised by patients about these issues that you can share?
My experience of patients is that they trust NHS staff to be acting solely in their best interests. Sadly evidence demonstrates that this is not the case:
(9) Generally, what is your view on what a robust, transparent and proportionate response would look like fit for 2015 and beyond?
I hope that I have given an indication of my perspective on this. I am most grateful to the Scottish Government for seeking my views as petitioner. I wondered if it might be helpful to conclude this letter with a range of views of some others who have also considered this area:
Dr McCartney, General practitioner in Glasgow, BMJ Columnist, Broadcaster and Medical Author
When politicians are held to higher standards than doctors, it is my view that it is time for tighter regulation of conflicts of interest in healthcare in Scotland.
Scottish Government guidance, HDL 62, has relied on self regulation and this clearly has not worked.
Moves by the drug industry are welcome but will encounter the same issues as HDL 62.
As a scientist as well as a student of humanities, my view is that Scotland’s wellbeing, reputation and worldwide standing would all benefit from taking a leading approach in this area.
I hope this update is of some assistance to the Committee ahead of the 31st March 2015.
Full details of all evidence I have collected for this petition, including my writings, publications and films, can be accessed from this one page.
Letter to the Petitioner from Gordon Clark, The Scottish Government, Healthcare Quality and Strategy Directorate, Pharmacy and Medicines Division.