Press release: Regulator seizes almost 10,000 unsafe STI + HIV test kits

Almost 10,000 sexually transmitted infection (STI) and HIV test kits which could give unreliable and false results have been seized by the Medicines and Healthcare products Regulatory Agency (MHRA) since 2015. Today the Agency are warning people to make sure that they are purchasing from safe and legitimate sources and avoid fake STI and HIV test kits which could give unreliable and false results.

Fake test kits could potentially give false negatives and lead to an increase in diseases such as chlamydia, syphilis and gonorrhoea as well as HIV. A false negative test result occurs when the test shows negative and the person is instead positive.

Online marketplaces are a known avenue where potentially unsafe test kits are being sold. While MHRA works with companies to remove these types of products from sale, the next stage of the #FakeMeds campaign intends to educate people buying STI & HIV test kits online.

Do not use any kit that has not been sealed, that has damaged packaging or is outside of its expiry date.

Make sure that the instructions for use are clear, easy to follow and written in understandable language.

If you have any concerns about the quality of a self-test kit, report it to the MHRA using the Yellow Card Scheme.

Approved self-testing kits carry a CE mark – this shows that they have gone through the proper regulatory processes and, when used in accordance with their instructions, are safe to use. Approved kits should also clearly state they are intended for use as self-tests.

Separate MHRA research has revealed people are prepared to buy risky products over the internet.

25% of young people1 have bought medical products online in the past 12 months and almost 1 in 10 (9%) admitted to buying products they knew, or strongly suspected, to be falsified.

More than 6 in 10 of those surveyed (63%) bought STI test kits after reading articles about home testing kits on a website, forum or blog and 64% wanted to avoid the embarrassment of buying the kits in a shop or pharmacy.

MHRA’s Devices Group Manager, Graeme Tunbridge:

Know what you’re buying by purchasing self-test kits and other medical devices from a safe and legitimate provider. Look for the distance selling logo which means that the supplier is registered with the MHRA to sell medicines to the public and has been accredited as a legitimate source. Make sure that the test is easy to use and has clear instructions.

Alternatively, if you are buying a medicine online look for the distance selling logo, which means that the supplier is registered with the MHRA to sell medicines to the public and has been accredited as a legitimate source.

Michael Brady, Medical Director, Terrence Higgins Trust said:

It’s great that medical advances now mean there are increasingly more HIV and STI testing options available online. Improving access, choice and convenience of where and how to test are key components of our approach to HIV prevention and tackling STIs.

It is extremely worrying to hear about illegal and fake test kits being advertised online and THT supports the #FakeMeds campaign from the MHRA. We agree that it’s really important for people to know that what they’re purchasing is safe, effective and will reliably diagnose or exclude STIS and HIV.

Dr Oscar quote:

It is terrifying that there are so many fake and dangerous STI test kits out there, which could cause people to unwittingly spread infections and diseases.

Be safe and make sure you are buying legitimate products.

“If you suspect you may have an STI, please visit your local GP or healthcare professional – it’s much better to be safe than sorry.”

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1 MHRA qualitative research of 1,009 18-30 year olds.

Link: Press release: Regulator seizes almost 10,000 unsafe STI + HIV test kits
Source: Gov Press Releases

Press release: “We must work with charities to address systemic underreporting of serious incidents by charities”

The Charity Commission says it continues to have concerns about systemic underreporting of serious incidents by domestic and international charities, as it publishes the findings of its interim taskforce on safeguarding.

The task force – one of a suite of measures announced by the Commission – was set up to respond robustly and consistently to the significantly increased volume of serious incident reports on safeguarding matters submitted by charities following the safeguarding revelations involving Oxfam and Save the Children in February.

Charities submitted a total of 2,114 reports of serious incidents relating to safeguarding incidents or issues between 20 February and 30 September 2018, compared to 1,580 serious incident reports about safeguarding received in the whole of 2017-18, and 1,203 received in 2016-17.

The Commission says that it is vital that charities, whether they work domestically or around the world, report serious incidents to the regulator. Doing so provides reassurance that trustees are responding appropriately and as the public would expect to the issue itself. The Commission says data on serious incident reporting also allows it to better understand risks facing the sector and take appropriate action.

The taskforce also undertook a ‘deep dive’ of the regulator’s records relating to safeguarding concerns dating back to April 2014 to identify any potential failure in full and frank disclosure by charities, and to ensure charities and the Commission had taken appropriate follow-up actions to deal with the incident reported.

Analysis of reports

The regulator undertook detailed analysis of safeguarding reports it received between 1 February and 31 May 2018 (1228 in total) to better understand the nature of the incident being reported and the type of charity making the report.

This found that:

  • The top 5 types of charity that submitted reports during that time were: overseas aid/ famine relief (29%), disability (12%), religious activities (12%), education /training (12%) and younger people (11%)
  • The majority of reports related to incidents of or concerns about potential harm to individuals, including but not limited to sexual abuse or harassment
  • In cases where an individual was identified as having allegedly been harmed, 47.5% related to a child, and 32% related to an adult (in the remainder the age of the individual could not be identified from the initial report).

Significant and systemic underreporting

The Commission’s report finds that, despite recent increases in serious incident reporting, there is significant and systemic underreporting of incidents by charities working at home and abroad:

  • only 1.5% of registered charities have submitted any kind of serious incident report since 2014
  • only 0.9% of charities have reported a safeguarding incident since 2014
  • it is concerned in particular that there may be certain groups of charities in which under-reporting is especially prevalent

Sarah Atkinson, Director of Policy, Planning and Communications at the Charity Commission, said:

The public rightly expect charities to demonstrate the highest standards of ethical behaviour and attitude. That includes taking action when something has gone badly wrong, or when there’s been a near miss. Making a serious incident report to the Commission is not in itself an admission of wrongdoing or failure. Quite the reverse: it demonstrates that a charity is responding properly to incident or concern. So we welcome the increase in reporting by some charities, especially international aid charities that appear to have improved their reporting since February’s revelations. But we’re not convinced that we’re seeing everything we should be. Working with charities, we need to bring about a culture change on reporting to ensure charities are safe places, better able to make a difference to people’s lives.

The Commission has already updated its guidance in reporting serious incidents and is now taking a number of further steps:

  • in light of its commitment, set out in its new strategy to better understand the wider context in which charities work and to help shape the environment in which they operate, the Commission is now conducting further analysis on the patterns of reporting types or groups of charities where under-reporting may be especially prevalent
  • developing a new digital tool for reporting serious incidents to help make it easier for charities to provide the information the Commission needs at the outset.
  • creating checklists to sit alongside its existing guidance to help better inform trustees about the key information required in any serious incident report. These checklists will be available in the next few weeks.
  • further reviewing its guidance on reporting serious incidents to ensure it is as clear and user friendly as possible
  • working with the sector and other government departments to raise awareness of the importance and benefits of reporting serious incidents and target under-reporting

“No major concerns” about historic reports of serious incidents

As part of its ‘deep-dive’, the taskforce reviewed over 5,500 historic records relating to safeguarding concerns dating back to 2014. The purpose of this work was to identify any possible gaps in full and frank disclosure in charities and to determine, based on the information in the regulator’s records, whether the Commission and charities had responded appropriately to each incident.

Today’s report makes clear that, based on the information recorded at the time, there are no historic cases giving rise to serious or urgent concerns about either the Commission’s handling at the time, or a charity’s response.

The taskforce identified only one case in which it was not clear, from the records, whether a potentially criminal matter had been reported to the police. The taskforce took quick action to ensure that the matter had been reported.

Sarah Atkinson said:

This deep-dive was an important, but limited exercise designed to interrogate our records and establish whether there are any red flags arising from the way a charity reported an issue to us, or from the way we responded at the time. I am reassured by the findings of this work, but would stress that any charity that may not yet have reported a historic serious incident to us, or may have concerns about the information they provided to us in a historic report, to take urgent action to remedy this by getting in touch with us.

Improved whistleblowing guidance

As part of its response to the safeguarding revelations, the Commission also committed to reviewing its approach to whistleblowing – reports from individuals currently involved in a charity as a staff member or volunteers.

The Commission has now published updated guidance that helps people better understand when, and how, they can report possible wrongdoing to the regulator so that it is as easy as possible for people who make what is often a brave decision to come to the Commission with concerns. The Commission is also providing further training for front line staff and managers on the knowledge and skills needed to handle whistleblowers and the concerns they raise effectively. It also plans to pilot a dedicated helpline service for whistleblowers starting later this year.

Updated guidance on reporting serious incidents by charities

The Commission has also updated its guidance to charities on reporting serious incidents, clarifying a number of areas where charities have indicated that it was not clear enough. For example, the Commission has provided additional guidance on when and how to report potential criminal offences that may have taken place abroad.

The regulator continues to review this guidance to ensure it is as clear and user-friendly as possible.

Ends

Notes to editors

  1. The Commission is the registrar and regulator of charities in England and Wales. We regulate over 168,000 charities working domestically and internationally.
  2. We opened a statutory inquiry into Oxfam in February and have published the scope of the inquiry. We also opened a statutory inquiry into Save the Children in April.
  3. The Charity Commission has an important regulatory role in ensuring that trustees comply with their legal duties and responsibilities in managing their charity. In the context of safeguarding issues, we have a specific regulatory role which is focused on the conduct of trustees and the steps they take to protect beneficiaries and other persons who come into contact with the charity.
  4. Our aim is to make sure that charities that work with or provide services to vulnerable beneficiaries comply with their legal duties, and take reasonable steps to protect them from harm and minimise the risk of abuse.
  5. Safeguarding has been a priority regulatory risk issue for the Commission since 2010 and this will continue. We have increased and intensified our regulatory interventions on safeguarding, including on a number of high profile cases, and our joint work with the Department for International Development and law enforcement agencies.
  6. Our remit requires us to work effectively with other UK specialist authorities. The Commission is not an inspectorate or agency, similar to CQC or Ofsted. We are not a criminal prosecuting authority, nor an arm of the police, which means we should not be expected to gather information for or report on charities’ behalf to the police or other regulators or agencies.
  7. Regardless of our specific remit and role, the number of incidents we are dealing with is increasing, and demand on our services in almost every area is growing. With around 350 permanent staff, dealing with 100,000 contact requests a year, regulating 950,000 trustee roles and 168,000 registered charities, we are limited in the proactive engagement we can have with individual charities and trustees.

Press office

Link: Press release: “We must work with charities to address systemic underreporting of serious incidents by charities”
Source: Gov Press Releases

BS EN ISO 14509-3:2018 Small craft. Airborne sound emitted by powered recreational craft Sound assessment using calculation and measurement procedures

Boats
Small
Noise (environmental)
Pleasure boats
Airborne noise
Acoustic measurement
Vessels
Marine engines
Acoustic testing
Sound intensity
Mathematical calculations
Outboard motors

Link: BS EN ISO 14509-3:2018 Small craft. Airborne sound emitted by powered recreational craft Sound assessment using calculation and measurement procedures
Source: BSI Standards