Dental amalgam toxicity reports to MHRA

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

You will be aware that you are required by an EU directive to monitor for any harm being caused by dental amalgam usage in the uk. In relation to that duty, please tell me the following information.

1. The measures you have been taking for the purpose of monitoring for possible harm being caused to patients by dental amalgam usage.

2. Details of any reports (such as via the Yellow Card system) you have received of suspected or believed or known cases of such harm caused by dental amalgam (other than local allergic reactions)(anonymized only insofar as necessary).

3. Details of any such reports since 2004 relating to persons living in Birmingham and born between 1950 and 1960.

4. What actions you have undertaken in response to any such reports.

Yours faithfully,

Mr Clarke

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
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hesitate to get in touch with us either on the number below or by
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***Please note the agency is closed on Monday 31 August 2015.***
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 15/431
       
Dear Mr Clarke,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 01 September 2015. 
       
We 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
       
Ben Scott
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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 15/431

Dear Mr Clarke,

Thank you for your enquiry dated 1 September 2015.

The safety of dental amalgam is reviewed every few years by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on behalf of the European Commission (EC) which consists of independent experts from European countries. This was carried out recently in April 2015. The SCENIHR concludes that, based on current scientific evidence, neither dental amalgam nor alternative materials are harmful to the health of the general population. A summary of the findings can be found in the following document:
http://ec.europa.eu/health/scientific_co...

The full SCENIHR report can be found here :
http://ec.europa.eu/health/scientific_co...

To answer your specific questions:

1. The measures you have been taking for the purpose of monitoring for possible harm being caused to patients by dental amalgam usage.

The MHRA monitors the scientific evidence available on the safety of dental amalgam and any adverse reports received via the Yellow Card Scheme.

2. Details of any reports (such as via the Yellow Card system) you have received of suspected or believed or known cases of such harm caused by dental amalgam (other than local allergic reactions)(anonymized only insofar as necessary).

The MHRA has not received any medically confirmed reports of adverse effects from the use of dental amalgam.

The MHRA has received four reports of concerns about the safety of dental amalgam. Due to confidentiality between the MHRA and the reporter we are unable to provide further details.

3. Details of any such reports since 2004 relating to persons living in Birmingham and born between 1950 and 1960.

Due to confidentiality between the MHRA and the reporter we are unable to provide this information.

4. What actions you have undertaken in response to any such reports.

The MHRA continues to monitor the scientific evidence available on the safety of dental amalgam and any adverse reports received via the Yellow Card Scheme.

If you have a query about this email, please contact the MHRA. If you are unhappy with the way your request has been handled, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4th Floor, Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ at the above address quoting the above reference.

After that, if you remain dissatisfied, you may ask the Information Commissioner at:

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

to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.

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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Dear MHRA Customer Services,
Thanks for your reply (though I find it unsatisfactory in some ways).

In the context of your not stating more details, I request that you clarify what you mean by:
(1) "medically confirmed reports of adverse effects from the use of dental amalgam."
and
(2) "reports of concerns about the safety of dental amalgam."

How for instance would a report be "medically confirmed", by what process?

And does "reports of concerns" mean an individual case of illness (of whatever cause) being reported or merely expression of concern that something could happen to one or more persons? Again, what process leads to such a report being generated.

Yours sincerely,
Mr Clarke

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Clarke,

Thank you for your e-mail.

Please see below responses to your questions:

In the context of your not stating more details, I request that you clarify what you mean by:
(1) "medically confirmed reports of adverse effects from the use of dental amalgam."

This refers to reporters who believe they have experienced physical symptoms from having dental amalgam. However, there was either no consultation with a healthcare professional or there was no clinical evidence to support these claims.

and
(2) "reports of concerns about the safety of dental amalgam."

This refers to information received from reporters who believe they have been exposed to a safety risk from having dental amalgam.

How for instance would a report be "medically confirmed", by what process?

By consultation with a healthcare professional e.g. dentist or GP

And does "reports of concerns" mean an individual case of illness (of whatever cause) being reported or merely expression of concern that something could happen to one or more persons? Again, what process leads to such a report being generated

“reports of concerns” refers to reporters who believe they have either experienced physical symptoms or have been exposed to a safety risk from having dental amalgam. Individuals can report their concerns voluntarily via the Yellow Card Scheme without consultation with a healthcare professional.

As indicated in our response to your FOI request we are unable to provide details of these reports due to confidentiality between MHRA and the reporter. We should have quoted the particular exemptions under the FOI Act in this response. We apologise for this omission. Please see below the specific exemptions that apply:

Section 40

The information requested contains the personal data of an individual or individuals and is subject to the exemption contained in section 40 (2) of the Act. We have concluded that disclosing this information would not be appropriate because it is personal information as defined in the Data Protection Act, the disclosure of which would breach the first principle of that Act which says that information must be processed fairly and lawfully. As an “absolute” exemption, there is no further requirement to consider the public interest.

Section 41

With respect to Section 41, a duty of confidence arises when one person (the “confidant”) is provided with information by another (the “confider”) in the expectation that the information will only be used or disclosed in accordance with the wishes of the confider.

For section 41(1)(a) to be met the information must have been provided by a third party, which is the case here.

For section 41(1)(b) to be met disclosure of the withheld information must constitute an actionable breach of confidence. In the view of the Information Commissioner's Office a breach will be actionable if:

1. The information has the necessary quality of confidence. (Information will have the necessary quality of confidence if it is not otherwise accessible and if it is more than trivial; information which is of importance to the confider should not be considered trivial.)

The information in question meets these criteria. It is not accessible other than via specific disclosure, is not trivial, but is of importance to the confider.

2. The information was communicated in circumstances importing an obligation of confidence. (An obligation of confidence can be expressed explicitly or implicitly. Whether there is an implied obligation of confidence will depend upon the nature of the information itself, and/or the relationship between the parties).

The information was imparted in circumstances importing an obligation of confidence. Generally, the nature of the relationship between the confider and the authority regarding this form of information clearly implies a duty of confidentiality.

3. Unauthorised disclosure would cause a specific detriment to either the party which provided it or any other party (although the approach taken by the courts in some cases is that detriment is not always a perquisite to an actionable breach of confidence).

With reference to the three criteria above, we believe that disclosure of the withheld information would constitute an actionable breach of confidence, and that the criteria are met with regard to the disputed information. The confiders would not expect to have the information revealed and, in the absence of a convincing public interest defence, we are of the view that disclosure would be a breach of their right to, and expectation of, confidentiality.

Although section 41 is an absolute exemption, the law of confidence contains its own built in public interest test with one defence to an action being that disclosure is in the public interest e.g. a need to reassure the public in terms of propriety or use of public funds etc. We do not consider in this case that there is any overriding public interest in the disclosure of this specific information. However, there is a public interest in maintaining trust and preserving the ability of the public authority to perform its functions by reassuring 3rd parties that information provided in confidence will be treated as such.

If you have a query about this email, please contact the MHRA. If you are unhappy with the way your request has been handled, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4th Floor, Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ at the above address quoting the above reference.

After that, if you remain dissatisfied, you may ask the Information Commissioner at:

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

to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.

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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