The reporting of vaccine side-effects should be made mandatory, a Conservative former minister said, as she criticised a culture of secrecy at the medicines regulator.

Esther McVey said there was a “gross underreporting” of the unintended impacts of vaccines, and said the Medicines and Healthcare products Regulatory Agency (MHRA) was in need of “substantial reform”.

Currently, patients are able to report side-effects of medication and treatments, including vaccines, through the MHRA’s “yellow card” scheme.

The reports are then reviewed by the regulator and, if necessary, they are withdrawn from the market or new guidance is issued.

Speaking in the Commons, Ms McVey said: “The yellow card is currently a voluntary scheme, which doctors and members of the public can report to, but I would like to echo the calls from the Sling The Mesh campaign and others to follow the example of Denmark and Sweden to make it mandatory for all healthcare professionals to report suspected adverse reactions.

“This reporting scheme should be a valuable source of information about possible harms, and to act as an early warning system. But we know that there is a gross underreporting to the scheme.”

The MP for Tatton went on to say: “Under-reporting is a big problem because it makes it difficult to spot safety signals and assigned causation.

“This then translates into unnecessary harm or deaths, with devastating side-effects from treatment going unnoticed for years, months or even decades.”

Ms McVey said it is estimated only 10% of serious reactions are reported to the MHRA, and hospital admissions as a result of the issue cost the NHS £2.2 billion.

She added that only 54% of deaths reported as potentially linked to Covid vaccines were followed up by the MHRA.

The MP criticised levels of transparency at the agency, referring to a statistic that only 41% of Freedom of Information requests to the body were answered between 2008 and 2017.

In 2021, 76% were answered within the 20-day legal limit.

She said: “A culture of delay, secrecy, has emerged and MHRA’s behaviour around the commission on human medicine meetings for Covid-19 Vaccine Benefit Risk working group show this beyond any doubt.

“Minutes of these meetings were published just last month, four years after the meeting took place. Why the delay, and they’re stuffed full of redactions which leave us with many more questions than answers?

“Particularly as to why these new vaccines were continually described as safe and effective.”

Tory former minister Sir Christopher Chope (House of Commons/PA)

Conservative former minister Sir Christopher Chope said a lack of openness only served to fuel a distrust of vaccines.

“(It) has got the consequence that, for example, MMR vaccines, there’s much less take-up than there should be and used to be, and that’s because of a lack of trust in the system,” he said.

Ms McVey replied: “If people lose trust in vaccines, if they lose trust in the pharmaceutical industry, if they lose trust in the regulatory agency, this is precisely what happens.

“And we know those vaccines are essential to many people, and that is not what we want to happen.

“We just want to make sure that new vaccines, new medicines coming to use, are thoroughly tested, and along the way we keep an overall watch that they are working correctly.”

Conservative shadow health minister Dr Luke Evans said: “Does the Government believe the yellow card system works? Or will it consider a review into this area?”

He added: “We must build a regulatory system that all can trust, and inherently do, but it’s easy to verify at any point. And if we can achieve this we can build a trusted ecosystem that’s good for innovation, good for the economy, and most importantly, good for the people.”

Concluding the debate on the performance of the MHRA, health minister Karin Smyth said: “The MHRA do recognise the need to constantly seek to improve its monitoring system to deliver better results.

“Recent improvements include implementing the new IT system, called Safety Connect, following recommendations from the Cumberlege review.

“The IT system will improve the efficiency of reporting and processing yellow card reports, much of which we have heard about today, supporting prompt identification and assessment of new safety concerns.”

Ms Smyth said more than 118,000 yellow card reports were assessed by the MHRA last year, and 134 safety signals were identified.

She continued: “The Government introduced in November last year the regulations to strengthen requirements for manufacturers to proactively monitor and report on medical devices once they’re on the market.

“Further reforms are planned to be laid before Parliament this year, including unique device identifiers and implant cards to improve the traceability of implanted devices, as well as increasing the classification of devices to ensure they receive the highest scrutiny throughout their lifetime.”