Request

Under the FOI Act (2000), please provide the following information. Who investigates and determines serious Adverse Drug Reaction reports (ADRs) to determine whether reported persistent or significant disability qualifies for compensation through the Vaccine Damage Payment Scheme? Which, if any, third parties are used?

Response

Investigating Adverse Drug Reaction Reports

I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by the NHS Business Services Authority.

However, it is possible that the Medicines and Healthcare products Regulatory Agency (MHRA) or the Department of Health and Social Care may hold some or all of the information you require. They can be contacted at:

MHRA Freedom of Information Team 10 South Colonnade London E14 4PU Email: info@mhra.gov.uk Web: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Department of Health and Social Care Ministerial Correspondence and Public Enquiries Unit Department of Health and Social Care 39 Victoria Street London SW1H 0EU United Kingdom Email: dhsc.publicenquiries@dhsc.gov.uk

Determining Vaccine Damage Payment Scheme Claims

The Vaccine Damage Payment Scheme (VDPS) provides a one-off tax-free payment, currently £120,000, to successful applicants where, on very rare occasions, a vaccine has caused severe disablement. The VDPS is not a compensation scheme. A claimant could still seek damages in court.

To qualify for a Vaccine Damage Payment, a claimant needs to prove that

• on the balance of probabilities, the vaccine caused their disability, and
• the resulting disablement is severe (60% or more)

The VDPS will contact all the healthcare providers listed on a claim form for a Vaccine Damage Payment to request a copy of the claimant's medical records. After we receive full medical records, we prepare the claim and send it to an independent medical assessor.

All claims are assessed by the independent medical assessment company with a consistent approach. Each case is considered on its own merits, by an experienced independent medical assessor. All of the independent medical assessors are General Medical Council (GMC) registered doctors with a license to practise.

Medical assessors will consider clinical research, epidemiological evidence and the current consensus of expert medical opinion together with a claimant’s application and their medical records from their healthcare providers to make a clinical assessment on whether it is more probable than not that the vaccine has caused disablement, and if so, whether that disablement is severe.

Information about the medical assessment is available on our website: www.nhsbsa.nhs.uk/vaccine-damage-payment-scheme-vdps-claim-process

Third parties used by the NHSBSA in VDPS assessments

All VDPS claims are medically assessed by an independent medical assessor. We have a contract with Crawford & Company for the provision of medical assessments under the scheme.