Author Archives: HM Government

MHRA investigation results in guilty pleas for supplying unlicensed, and potentially dangerous, medicinal products.

Gediminas and Vytautas Staskevicius appeared in the Oxford Crown Court charged with offences under Trade Mark, Misuse of Drugs and medicines regulatory legislation. The two men were set to go on trial for charges relating to offences in between May and July 2015. But, before the trial could begin, the two men pleaded guilty to all charges.

Gediminas has been sentenced to 16 months imprisonment, suspended for 2 years. Gediminas must also complete 120 hours of unpaid work and pay £1,500 in costs. Vytautas has been sentenced to 8 months imprisonment, suspended for 2 years. Vytautas is also subject to a curfew between the hours of 9pm and 7am, lasting for two months.

The Medicines and Healthcare products Regulatory Agency (MHRA) began investigating Gediminas Staskevicius in May 2015. We received information that suspected illegal medicines were delivered to Gediminas’ address. In addition, an unknown person used a post office near Gediminas’ home to post counterfeit medicines to various international destinations.

In July 2015, enforcement officers from the MHRA entered the men’s residence, and storage units hired in their names. The officers found almost 470,000 tablets of unlicensed erectile dysfunction medication, counterfeit medicines and the class C controlled drug Tramadol. The officers also found over £6000 in cash and electronic records of medicines trading including customer details.

Selling medicines which are unlicensed, controlled or counterfeit is not only illegal but also poses a serious health risk to the public. The medicines sold illegally by these men are potent and can cause serious side effects.

We are currently running our #FakeMeds campaign to raise awareness of the risks of buying fake medical products online, and to encourage people to buy medicines and medical devices safely.

Alastair Jeffery, Head of Enforcement for MHRA, said:

Fake and unlicensed medicines pose a serious health threat.

There is no way of knowing whether they are acceptably safe. There are also no guarantees as to what unlicensed medicines contain; there may be impurities or incorrect ingredients which affect their safety and performance.

We will continue to target criminals supplying illegal medical products and raise awareness of the harm fake medicines cause.

You can avoid risking your health, and wasting money, by buying licensed medicines from legitimate high street or online retailers.

Background

1. MHRA is responsible for regulating all medicines and medical devices in the UK. Our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk
2. Check whether a website can sell medicines online by searching our registry.
3. Online retailers displaying the distance selling logo are registered with the MHRA to supply legitimate medicines.
4. www.gov.uk/fakemeds
5. Follow #FakeMeds on Twitter

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The Competition and Markets Authority (CMA) stepped in after the UEA made significant changes to the content of a course – by introducing compulsory modules thus limiting students’ choice of optional modules – and not adequately informing prospective students who had received course offers about the changes.

UEA regarded the changes as ‘minor’ – in line with its contract terms at the time – and therefore did not consult existing students or inform offer holders immediately, as they would have done if they had considered the changes to be ‘substantial’. The CMA welcomes UEA’s undertaking which ensures that, in future, it will treat the addition of a compulsory module to a course as a ‘substantial change’.

UEA has also confirmed that it will make timely updates to its website of any substantial changes. This will ensure that anyone thinking about applying has access to up-to-date and accurate information.

Nisha Arora, CMA Senior Director, Consumer, said:

For most students, going to university is an expensive, once-in-a-lifetime event and they should enjoy the best possible experience. So it’s important that prospective students have accurate and up-to-date information when choosing their course and existing students are given timely information about any substantial changes that are made to their course. And any contract terms which deal with variation, for example to course content, must be fair.

The CMA welcomes UEA’s constructive approach and its commitment to revise its terms and conditions and comply with consumer protection law.

The CMA published advice for higher education providers on how to comply with consumer protection law in March 2015, as well as guidance on consumer rights for students.

Following that work, the CMA launched a compliance review and published the results in July 2016. The review revealed that awareness of consumer protection law obligations has increased since the CMA’s work began in this sector with many universities reporting improvements in their practices and terms. However, the CMA’s review also revealed examples of poor practice.

The CMA has now secured commitments from 6 universities since November 2015. Further information about the compliance review and the action taken to date against universities, is on the case page.

Notes for editors

1. The CMA is the UK’s primary competition and consumer authority. It is an independent non-ministerial government department with responsibility for carrying out investigations into mergers, markets and the regulated industries and enforcing competition and consumer law. For CMA updates, follow us on Twitter @CMAgovuk, Flickr, LinkedIn and like our Facebook page.
2. UEA fully co-operated with the CMA’s investigation and agreed a Part 8 undertaking with the CMA, which reflected the changes which it had made voluntarily to its terms and conditions.
3. The key pieces of consumer protection legislation relevant to this investigation were the Consumer Protection from Unfair Trading Regulations 2008, the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 and the Consumer Rights Act 2015, Part 2 and the Unfair Terms in Consumer Contracts Regulations 1999 (for contracts concluded prior 1 October 2015).
4. The above legislation is enforced through the courts. Ultimately, only a court can determine whether a particular term or practice infringes the law and no such finding has been made in this case.
5. UEA made changes to the content of Year 2 of its 4-year undergraduate American Literature with Creative Writing course. Prior to the changes being made, Year 2 of this course consisted entirely of optional modules. Year 2 was changed when UEA introduced 2 new compulsory modules which then reduced the number of optional modules that students could choose to take. UEA considered that these changes enhanced the course and were of benefit to students.
6. UEA of its own accord made concessions to existing students on the American Literature with Creative Writing course BA, for example, allowing them to pursue optional modules which were not in the new course profile.
7. Media enquiries should be directed to Simon Belgard (simon.belgard@cma.gsi.gov.uk, 020 3738 6472).

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The Heritage Lottery Fund (HLF) has approved the development stage and initial funding of £3.8million for the 5 year “Bats in Churches” partnership project, bringing together wildlife and heritage conservation and church organisations to save bats and protect churches.

The ground-breaking project will:

• trial and perfect new techniques to enable bats and church congregations to live together
• build up professional expertise and volunteer skill to share the best solutions with hundreds more churches
• bring together church communities and bat enthusiasts to create a shared understanding and appreciation of England’s historic places of worship and our rare flying mammals

Natural England’s Chairman, Andrew Sells, said:

This is a splendid result for both congregations and bats, who have shared churches for centuries but not always happily. We’ve been working very hard for a number of years with our partners to find ways to help bats and people coexist peacefully in these beautiful, historic buildings. This funding will allow us to capitalise on that good work and find innovative new ways of resolving the conflict. It will provide a lasting legacy for these wonderful churches and the people and bats that rely on them.

The project will provide help and support to places of worship across England where large bat populations can sometimes have a negative impact on historic buildings and the communities who use them.

HLF’s CEO, Ros Kerslake, said:

We welcome this unprecedented co-operation between church leaders and bat conservationists. It’s a positive move forward and should provide a practical solution to what has become a national problem.

Bats in Churches’ is being made possible thanks to National Lottery players’ money. The legacy of our £3.8m investment will be a major step change in how this issue is approached in the future. Local communities who work hard to look after and use their churches, precious bat populations and historic church buildings are all set to benefit. The most immediate outcome is developing proposals for 100 churches in England to put in place solutions to protect resident bat populations whilst preventing further damage to the buildings.

The UK has internationally important populations of bats, which are at risk, because of decreases in woodland where some species hunt for insects, conversion of barns, loss of natural roosting sites and changes in farming practices. Due to significant historical declines in bat populations in the UK, all bats have been protected under British law since 1981. Churches can be important sanctuaries for bats for maternity roosts and hibernation.

Whilst small bat populations can occupy parts of a church without disturbance, in other cases bats can pose severe financial and social problems for congregations. At a time when churches are increasingly becoming community hubs with a diversity of events and uses, bat droppings can restrict activities, damage historic artefacts, cause hygiene issues and put strain on the volunteers who look after these beautiful buildings. In rare cases large bat roosts have even caused churches to close.

Rt Hon Sir Tony Baldry, Chair of the Church Buildings Council, said:

This grant should help us better manage bats in churches. We are not opposed to bats, they are intriguing creatures and part of God’s creation, but they can do enormous damage in churches. I am delighted that this innovative project can now go ahead.

The partnership includes Natural England, Church of England, Bat Conservation Trust, Historic England and the Churches Conservation Trust.

Julia Hanmer, Joint Chief Executive of the Bat Conservation Trust said:

Bats have suffered massive population declines and churches provide important safe spaces for nine species to shelter. We are delighted that with this funding from HLF, church communities and bat workers can together play a significant role in supporting these vulnerable and fascinating species, whilst at the same time protecting historic medieval church buildings and opening church doors to wider communities.

Deborah Lamb, Deputy Chief Executive of Historic England said:

We welcome every opportunity to help congregations that work hard to care for church buildings, providing public space for community activity and a wonderful treasury of historic monuments, brasses, woodwork and craftsmanship. This project will offer practical help to those coping with the additional challenge of living with bats and encourage volunteers who are interested in bats to discover more about local churches.

Crispin Truman OBE, Chief Executive of the Churches Conservation Trust said:

Our national collection of 350 churches is home not only to great architecture, history and exquisite medieval art, but also to important natural resources including precious species of bats. The relationship between the two has not always been harmonious so we are delighted this project which celebrates both, has been awarded funding from the Heritage Lottery. It will enable us to better protect churches and their inhabitants, as well as supporting the communities who care for historic churches so that both can thrive.

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