Who should of protected the health and interests of UK drug trial volunteers in 1995?

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

In response to this FOI request.

https://www.whatdotheyknow.com/request/e...

Your helpline wrote;

"Dear Fiona,

Thank you for your query.

Following the implementation of the Clinical Trials Directive 2001/20/EC
on 1 May 2004, compliance with the principles of GCP became a legal
requirement for everyone in the European Union involved in the conduct of
a clinical trial with an investigational medicinal product. Compliance
with GCP provides assurance that the rights, safety and well-being of
trial subjects are protected and that the results of the clinical trials
are credible and accurate. The Clinical Trials Directive was transposed
into UK law by the publication of The Medicines for Human Use (Clinical
Trials) Regulations 2004, Statutory Instrument No. 1031."

FOI question;
In 2015, what should a member of the public do if they have been unable to find out why some volunteers became anxious and ill during and AFTER this drug trial?

https://www.whatdotheyknow.com/request/s...

https://www.whatdotheyknow.com/request/d...

My supporters and I have been forced to progress these queries due to our failure to source the requested data from Manchester University, NHS England and Astrazeneca since May 2014.

Yours faithfully,

Fiona Watts

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 15/374
       
Dear Ms Watts,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 23 July 2015. 
       
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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IE&SFOI, Medicines and Healthcare Products Regulatory Agency

13^th August 2015
Ms Fiona Watts
[1][FOI #282163 email]
 
 
 
 
Dear Ms Watts,
 
REF: FOI 15/374
 
I am writing in response to your FOI request dated 23^rd July 2015. I have
associated our response to your question:
 
In 2015, what should a member of the public do if they have been unable to
find out why some volunteers became anxious and ill during and AFTER this
drug trial?
 
Following the implementation of the Clinical Trials Directive 2001/20/EC
on 1 May 2004, compliance with the principles of GCP became a legal
requirement for everyone in the European Union involved in the conduct of
a clinical trial with an investigational medicinal product. Compliance
with GCP provides assurance that the rights, safety and well-being of
trial subjects are protected and that the results of the clinical trials
are credible and accurate. The Clinical Trials Directive was transposed
into UK law by the publication of The Medicines for Human Use (Clinical
Trials) Regulations 2004, Statutory Instrument No. 1031.
 
This Statutory Instrument and its subsequent amendments sets out the
requirements by which trials are approved by the MHRA (the UK Competent
Authority) and the Health Research Authority (parent organisation of the
National Research Ethics Service); and sets out the requirements by which
trials must be conducted and are regulated (including the basis for
inspection and enforcement).
 
The function of the MHRA GCP Inspectorate is to assess the compliance of
organisations since the implementation of the UK and EU legislation
relating to the conduct of conduct clinical trials of investigational
medicinal products as part of the MHRA's mission to safeguard public
health.
 
If you have a query about this letter, please do not hesitate to contact
me at IE&[email address]
 
If you are unhappy with our decision, you may ask for it to be reviewed. 
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not previously been involved in your request. If you wish to pursue that
option please write to the Communications Directorate, Medicines and
Healthcare products Regulatory Agency, 151 Buckingham Palace Road, London,
SW1W 9SZ.
 
After that, if you remain dissatisfied, you may 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
 
Inspection, Enforcement and Standards FOI Team
MHRA
 
cc      Policy Manager
 

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Dear IE&SFOI,

Firstly, you need to being clarity to your responses and provide the names of the "Policy Manager" copied into your last FOI response and the name of who is responsible for these replies to my FOI enquiry.

Secondly, in respect of UK data laws, please explain where in your FOI responses you have answered my enquiry in respect of the date "1995". My enquiry was in relation to the specific date '1995" but your department seemed to have ignored this date in your responses?

Yours sincerely,

Fiona Watts

IE&SFOI, Medicines and Healthcare Products Regulatory Agency

Dear Ms Watts,

Many thanks for your email.

It is the agency's position -which is in line with that of the ICO- that it would not be fair or lawful, under the first principle of the Data Protection Act 1998, to reveal the names of staff below SCS (Senior Civil Servants) in official correspondence.

In relation to your actual request, can you clarify whether it was a healthy volunteer trial or not?

Yours sincerely

Inspection, Enforcement and Standards FOI Team
MHRA

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Dear IE&SFOI,

You seemed to have asked for me to reclarify my FOI?

I started enquiries on this issue in May 2014 and hit brick wall after brick wall.

In 1995, which organisation or department in Public Office was responsible for overseeing the quality and safety of drug trials which volunteer students would have volunteered for?

Which Government department in the UK in 1995 was responsible for the safety of volunteers in drug trials?

Yours sincerely,

Fiona Watts

IE&SFOI, Medicines and Healthcare Products Regulatory Agency

2 Attachments

Our ref: FOI 15/374

 

Dear Ms Watts

 

I am sorry that you felt our reply of 13^th August did not address the
question which you had put in the subject header of your email dated 23^rd
July: “Who should of protected the health and interests of UK drug trial
volunteers in 1995?”. I regret that the reference to the year 1995 was not
spotted when we provided a response to the following statement and
question which formed part of the body of your email:

 

“FOI question;
In 2015, what should a member of the public do if they have been unable to
find out why some volunteers became anxious and ill during and AFTER this
drug trial?”

 

Our previous response indicated that the Clinical Trials Directive
2001/20/EC was implemented on 1 May 2004 at which point “compliance with
the principles of GCP became a legal requirement for everyone in the
European Union involved in the conduct of a clinical trial with an
investigational medicinal product. Compliance with GCP provides assurance
that the rights, safety and well-being of trial subjects are protected and
that the results of the clinical trials are credible and accurate. The
Clinical Trials Directive was transposed into UK law by the publication of
The Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory
Instrument No. 1031”.

 

On 2^nd September you clarified your request by way of asking a further
two questions:

 

“In 1995, which organisation or department in Public Office was
responsible for overseeing the quality and safety of drug trials which
volunteer students would have volunteered for?

Which Government department in the UK in 1995 was responsible for the
safety of volunteers in drug trials?”

 

Starting with your first question, in 1995, clinical trials were not, as
such, regulated.

 

What was controlled was the selling or supply of medicinal products for
use in a clinical trial through the issuing of Clinical Trial Certificates
(CTC) or exemptions (CTX) by the Licensing Authority. Phase 1 trials
conducted in Healthy Volunteers were not under the control of the
Medicines Act 1968 and did not need authorisation from the Licensing
Authority; and Doctors and Dentists using largely marketed products were
able to obtain authorisation to start trials through the Doctors and
Dentists exemption (DDX). Once the trial was authorised to start there was
no further oversight from any Public Office at that time and there were no
Good Clinical Practice (GCP) inspectors and no legal standards to inspect
against. It was normal then to obtain ethical approval from an Ethics
Committee before starting a trial although this was good practice and not
a legal requirement; and Research Governance in the NHS did not exist in
1995.

 

In short, prior to 2004 when the current legal basis for regulating
clinical trials was introduced in the EU, the safety of the trial
participants in a trial, once authorisation to use the medicinal products
was given by the Licensing Authority, was largely the responsibility of
the doctors conducting the trial, and possibly their employer.

 

If you’d like to review the legislation in place at that time, the
Medicines Act 1968 is publicly available at the following link:
[1]http://www.legislation.gov.uk/ukpga/1968...

 

To answer your second follow up question, the Medicines Control Agency
(MCA), was a part of the Department of Health and Social Security. The MCA
was the government body responsible for the regulation of medicinal
products (before merging with the Medical Devices Agency in 2003 and
becoming the MHRA). It produced some guidance called:

 

·         Medicines Act Leaflet – A Guide to the Provisions Affecting
Doctors and Dentists

 

The Medicines and Healthcare products Regulatory Agency, which is
sponsored by the Department of Health, also produced the following:

 

·         Medicines Act 1968 – Guidance Notes on Applications for Clinical
Trials Exemptions and Clinical Trials Certificates

 

I have enclosed a scanned copy of the leaflet and the introductory pages
to the second document. Please note that both these documents were revised
after 1995. I have searched our index of archived paper records and do not
believe that the agency still holds the earlier versions but, hope you
find these useful.

 

I trust the attached documents and above explanation will help you to
understand better the regulatory situation in 1995 and apologise again
that this was not explicitly stated in our original response.

 

Yours sincerely

 

IE&S FOI Team

MHRA

 

cc Policy Manager

 

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