Lobbying by Pharmaceutical Companies

Philip Deans made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,
Dear National Institute for Health and Care Excellence,

(1)Do any pharmaceutical companies lobby MHRA to change policy or guidelines to benefit any one particular pharmaceutical company?

(2) Is any policy changed by MHRA through lobbying by a pharmaceutical company that is not based on independent clinical evidence?

(3) Do any employees of MHRA receive any gifts, money, rewards, incentives, hospitality or any other type of financial benefit from any pharmaceutical company? Or do any pharmaceutical company attempt to offer money, gifts or financial rewards by an attempt to change policy?

Yours faithfully,

P Deans

Yours faithfully,

Philip Deans

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/263
       
Dear Mr Dean,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 22 April 2016. 
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

FOI 16/263

10 May 2016

Dear Mr Deans,

Thank you for your Freedom of Information Act (FOIA) request of 22nd April 2016, addressed to the Medicines and Healthcare products Regulatory Agency (the agency) and the National Institute for Health and Care Excellence (NICE).

As NICE is a separate organisation, if you wish to seek information from them, you will need to contact them directly at [email address].

Applicants’ rights under the FOIA are, in general, to be told whether the information described in the request is held by the public authority; and if it is, to receive a copy of the information, unless an exemption applies.
The wording of your questions is open to interpretation and we are unable to respond without further clarification. To deliver our duty under the FOIA we need to be able to search for information, this often requires the request to be specific. I would also note that “policy or guidelines” covers a large range of things within the agency from health and safety policies to the licensing process.

I have noted specific comments to highlight this below.

(1) Do any pharmaceutical companies lobby MHRA to change policy or guidelines to benefit any one particular pharmaceutical company?

The agency interacts with a range of stakeholder, including pharmaceutical companies, on a frequent basis and in a variety of ways to carry out its role. For example, the MHRA provides a quarterly consultative forum in which pharmaceutical trade associations and companies can discuss topics of interest. Any suggestions from industry for changes to the way in which the agency works would be assessed internally by the MHRA and, if deemed appropriate, taken forward. This would frequently involve various means of wider consultation.

The agency is open about its relationship with all stakeholders but it does not record requests for changes as ‘lobbying’, it is therefore not possible to search for examples using this term.
Equally, the agency would not necessarily know (or be able to work out), and therefore would not record, how many pharmaceutical companies would benefit from a change – i.e. if a change would only benefit one company but not others.

I would, therefore, ask you to consider how you may re-phrase your request to narrow its focus to something that might achievable within the fee limit, which is set at 24 working hours, since a search of all our recorded interactions with pharmaceutical companies would certainly exceed this and be unlikely to yield results. For example, you might like to ask for the notes/minutes of our consultative forum over a set time period; or phrase a particular question about the development of a change to a particular policy or guideline.

(2) Is any policy changed by MHRA through lobbying by a pharmaceutical company that is not based on independent clinical evidence?

Building on the points above, please can you confirm what you mean by ”lobbying”? Concerning individual product licences and advice the MHRA gives prescribers and patients; this is determined by data submitted by marketing authorisation holders and data collected from the actual use of the product itself in the clinical setting. However, not all changes would require clinical evidence, if their focus is not related to the use of a product in a clinical setting, e.g. Fees Policy. Do you have a specific policy or list of policies in mind as the scope of your request is currently too broad?

(3) Do any employees of MHRA receive any gifts, money, rewards, incentives, hospitality or any other type of financial benefit from any pharmaceutical company? Or do any pharmaceutical company attempt to offer money, gifts or financial rewards by an attempt to change policy?

In line with the agency’s Conflict of Interest policy all members of staff, including the Executive Board and Non-Executive Directors, are required to immediately declare any financial or other interests as and when they arise. Staff members may not hold direct financial interests in the pharmaceutical and healthcare (medical devices) industries. Newly appointed staff will be required to dispose of such interests before taking up employment with the agency. Similarly, staff may not hold any employment or directorships in the pharmaceutical or healthcare (medical devices) industries, nor carry out consultancy or other private work for those industries. The declaration process is completed by all staff annually.

No staff have received any financial benefits from pharmaceutical companies and we have no record of attempts being made to offer financial incentives to influence policy direction.

I regret that your requests in (1) and (2) above are currently too broad to enable the agency to determine whether it holds the requested information. I am therefore closing this request. Should you wish to pursue this, please refine and narrow the focus of your request and we will be happy to re-consider it.

If you are dissatisfied with our decision, you may apply within two months, for an internal review by emailing or writing to our Customer Services team at:

[MHRA request email]; or

Communications Directorate
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
London, SW1W 9SZ.

Should you remain dissatisfied with the outcome of an internal review, you would be entitled to write to the Information Commissioner at:

The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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