Room 317 Richmond House
79 Whitehall
London SW1A 2NL
Telephone: 020 7210 5000


11 March 2010
Dear Ms Castellina

Thank you for your email of 7 March in which you requested an internal review following the Department of Health’s response to your FOI request.The request for information and its background You wrote to the Department on 5 February 2009. On 4 March, the Department of Health replied as follows:

Thank you for your email of 5 February asking, under the Freedom of Information Act (FOIA), for the information detailed below. We are addressing your queries in the order in which they appeared in your

1. Please give the names of any external (or internally employed) professional medical practitioners who have given opinions or views to NHS policy advisers, Ministers, CMO or special advisers about ME/CFS in the last two years.

We confirm that we hold information falling within this description, but have concluded that it should be withheld under S40(2) of the FOIA, which relates to the personal data of living individuals, release of
which would be in breach of any of the Data Protection Principles set out under the Data Protection Act. We consider that the data which we hold does indeed constitute personal data and that it would not be
‘fair and reasonable,’ as understood in the context of the Data Protection Principles, to release it.

2. Does the NHS or the Dept of Health keep statistics on the effects of its vaccination programmes in schools e.g. negative health effects from TB jabs in triggering ME/CFS?

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme; the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom for all
medicines and vaccines. Each Yellow Card report we receive contributes to medicines safety monitoring. This will include any reports of suspected ME/CFS following vaccinations. We are aware of no evidence to suggest that any vaccine is causally associated with development of ME/CFS. It is important to note that a report of an Adverse Reaction does not necessarily mean that it was caused by the medicine or vaccine. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and any underlying disease. The HPV vaccination programme is largely administered in schools and colleges. Statistics on reported adverse reactions associated with
HPV vaccination are publicly available at I can confirm that we hold copies of these statistics. However, because this information is reasonably accessible by other means, it is exempt
under section 21 of the FOI Act and the Department is not obliged to respond further.

Statistical information about reported adverse reactions associated with other childhood vaccines (i.e. those not usually administered in schools) is also available from the MHRA on request. Please find
attached an up to date Drug Analysis Print (DAP) which details all UK spontaneous 'suspected' ADR reports associated with Bacillus Calmette Guerin (BCG). It is important to note that BCG is also used
for the treatment of bladder carcinomas and therefore not all ADR reports included on this print will relate to the use of BCG for vaccination against tuberculosis. Please also find attached a guidance sheet to help you interpret this print. I should add that the national schools programme of BCG vaccination against tuberculosis (TB) was replaced by a targeted programme in 2005.

Does the NHS or Dept of Health keep records on physical outcomes from the medical treatment of "graded exercise" in ME/CFS?

The Department of Health does not keep records of the physical outcomes from the use of graded exercise therapy (GET) in the management of CFS/ME. Locally, health professionals will keep records about the health of individual patients and the care that they receive. The Medical Research Council (MRC) is funding the PACE trial, a five year single blind random controlled test involving 600 participants to test four treatments:-
• standardised specialist medical care alone
• standardised specialist medical care plus adaptive pacing
• standardised specialist medical care plus CBT
• standardised specialist medical care plus GET

How many cases have been reported to the NHS Ombudsman relating to treatment of young people under the age of 35 with ME/CFS in the last two years?

The Department of Health does not collect this information. For any matters concerning investigations by the Parliamentary and Health Service Ombudsman (PHSO), you will need to write to the PHSO
direct at:

The Parliamentary and Health Service Ombudsman
Millbank Tower
SW1P 4QP.”


You replied on 7 March, requesting an internal review of theDepartment’s application of the section 40(2) exemption and submitting a further FOI request, which I can confirm is being processed separately to this internal review. The part of your email relevant to this internal review read:

I know the DH holds this information. I hardly need to remind the Department that using "S40(2)" is only permitted where it can be seriously argued that divulging personal names will cause serious distress, unwanted harassment of individuals. Clearly this is not relevant in this case. In this case, medical professionals should not be "protected" in this way (just as climate scientists should not be protected where scientific data is being used as "evidence") . Freedom of Information is about transparency in government, being open, wherever possible about those who advise government. S40(2), in this case, is being misused to prevent release of information on how policy decisions are taken relating to MC/CFS (which have life and
death outcomes and wider tragic effects on families and society e.g. in encouraging "assisted suicide"). I believe that its use in this case strongly suggests that the Dept of Health has uncertainty about
divulging the track records of its medical professional (e.g. psychiatrists) and advisors in relation to ME, in the face of overwhelmingly high levels of public interest among patient support groups, patients and their families. Using "S40(2)" prevents ME patients/experts examining what evidence NHS advisors are drawing
on and scrutinising their track record in treating ME, in other words their credentials to be DH "advisors". This information is required now by strong public (and now legal and also ethical) interest.”

Internal review
The application of s40(2) to withhold the names of professional medical practitioners has been re-examined in the light of your request for an internal review. We began by reviewing the Information Commissioner’s Guidance on the exemption for personal data1. The guidance states: “… wrongly releasing an individual’s personal information will breach the DPA [Data Protection Act 1998]. It is therefore very important to
understand and apply this exemption correctly to ensure compliance with both regimes. The exemption is an absolute exemption (except in some limited circumstances). This means that if the information falls
within the exemption, there is no need to consider an additional public interest test.Section 40(2) sets out the exemption for someone else’s personal data (third party data) if one of the conditions in section 40(3) or 40(4) is applied : ICO guidance on the exemption for personal information can be downloaded from:
These conditions require you to refer back to the DPA. The most common condition for the exemption to apply is where disclosure would breach one of the data protection principles contained in
Schedule 1 of the DPA. You will therefore generally need to start with two broad questions:
• Is the information “personal data”? If so, will disclosure breach one of the data protection principles?”
We then examined whether any of the conditions in section 40(3) or 40(4) were met. We concluded that section 40(2) was legitimately engaged, as disclosure of such professional medical practitioners’ names would not be warranted by reason of prejudice to the rights, freedoms or legitimate interests of
such persons, and might put them at potential risk of harm or distress. This would mean that none of the conditions in Schedule 2 of the DPA would be met and moreover, as it would it would be unfair and unlawful to
release this information, it would breach the first data protection principle set out in Schedule 1 to the DPA. Accordingly, it is not legally possible to disclose this information. I can also confirm that we have taken into account the views of the individuals concerned in this case when coming to this conclusion.
Finally, given that s40(2) has been engaged by virtue of s40(3)(a)(i), the exemption is absolute and so the FOI Act does not require consideration of the public interest in declining to disclose the information.

The internal review is now complete.
If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner’s Office (ICO) for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Department. The ICO can be
contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane

Yours sincerely
Lynn Swyny
Freedom of Information Case Manager