FOI release

Freedom of Information request on the adverse incidents arising from COVID-10 testing and the legal requirements on labelling a diagnostic test (FOI 21-670)

Updated 27 April 2022

12th July 2021

FOI 21/670

Dear

Thank you for your information request, dated June 16th, where you asked for

1. Adverse incidents arising from all types of Covid testing in particularly allergic reactions to PCR test kits. I am particularly interested in allergic reactions as there are currently no latex free PCR test kits. If I can have as much information as I am allowed including for example which country - England/Wales etc, type of incident - allergy/anaphylaxis/injury etc, outcome - Dr/hospital/death, date of incident, date of report, brand of test, type of test, location - hospital/home kit/testing centre/drive through etc

2. Please could you also confirm what the legal requirements are on labelling a diagnostic test? If they contain latex or are manufactured in a latex environment (gloves used by workers etc) should they have a warning label? None of the PCR tests I have seen have had a latex warning on yet DHSC have written to me confirming no PCR kits are latex free.

3. If you know where I can access a latex free PCR kit that would also be useful please although I appreciate this last question is not MHRA responsibility.

Please find our answers below.

MHRA response to request 1:

We can provide you the following data breakdown of the reported adverse incidents to the MHRA between 23/04/2020 - 29/06/21, where allergic reaction was stated.

	SARS-CoV-2 PCR Test
	Adverse / allergic reactions, anaphylactic reactions, headache, respiratory effect, asthma, fatigue, skin inflammation / irritation, burning sensation	Anaphylactic reactions
England	53	<5
Wales	<5	0
Scotland	0	0
Northern Ireland	0	0
Unknown	<5	0
Grand Total	61	<5

Data for Scotland and Northern Ireland is not available , you may wish to contact each devolved administration directly at [email protected] and [email protected] respectively for available data they may hold.

Please note that we cannot confirm if these incidents are directly related to latex component in the specific test and not specific to any particular manufacturer.

However, the rest of the information that you have asked is exempt from release under section 44 of the Freedom of Information (FOI) Act.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business. The MHRA is satisfied that the information you have requested: • ·constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

MHRA response to request 2: Under the Medical Device Directive, the manufacturer has a responsibility to communicate effectively with users to inform them about residual risks to allow them to manage these risks effectively. Therefore, it is necessary to include appropriate warnings on the label and or instructions for use and should take the form of symbols to harmonised standards (ISO 15223-1) . The International Standard ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied - has a latex symbol that shall be used if there is a presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.

To further assist you with your query we contacted DHSC and would like to share their reply below which you might find helpful.

“DHSC are aware that PCR components may be exposed to latex in the production and transit phase, and therefore cannot be guaranteed to be free from natural rubber latex as delivered to end user.

In July 2020 grey mailing bags with latex warnings were introduced, following the first latex allergy customer complaint DHSC received. During this transition to bags with printed latex warning, latex warning labels were manually applied at kitting to the bags without printed latex warning symbols. From October 2020 to January 2021, grey mailing bags that did not contain the latex warning symbol were used in order to ensure availability considering public health needs of that period. One of the channels used a different packaging configuration, and therefore one latex warning symbol is being added to the secondary packaging.

The Label Specification for all PCR kits has been updated (released on 9th Jun 2021) to include a latex warning on the outer packaging (primary packaging) for a planned production from 1st July 2021, but there will be a delay in this stock reaching consumers. Latex-free PCR tests are not available at this time”.

MHRA response to request 3:

We are unable to provide the information requested with regards to where to access latex free PCR kits.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000