London medicines wholesaler sentenced for illegally importing and distributing over £2.9m of medicines

The owner of a medicines wholesale business was sentenced yesterday at Southwark Crown Court to 20 weeks imprisonment, suspended for 12 months and community service after pleading guilty on 20 June 2022 to importing and distributing medicines worth over £2.9m sale value without holding the correct licences

Between July 2017 and June 2018, Amr Mosa (36), director of Wimpole Pharmacie Ltd in London’s West End, imported medicines such as Herceptin, Avastin and Enbrel [1] from Egypt to the UK and then distributed them from the UK to a company based in Germany [2].

These medicines are prescription-only medicines to treat conditions as diverse as cancers and Crohn’s disease, that require storing at low temperatures. These are known as cold chain products.

Although Mosa’s company was granted a licence to distribute medicines within the European Economic Area (EEA) [3], the licence did not authorise the distribution of cold chain products, nor did it allow these to be imported into the UK from outside of the EEA.

In August 2018, the European Medicine’s Agency’s Rapid Alert Notification system flagged that a batch of medicines supplied to Germany by Wimpole Pharmacie Ltd had originally been stolen from Italian hospitals.

In response, the MHRA investigated the business and proved that the drugs were imported and exported without the correct licences, allowing unauthorised medicines to enter the European market.

The defendant was sentenced to a total of 20 weeks imprisonment, suspended for 12 months as well as 100 hours of unpaid work [4].

Andy Morling, Deputy Director of Criminal Enforcement at the MHRA, said:

It’s a serious criminal offence to import and distribute medicines without the right licences. We work closely with regulatory and law enforcement partners to identify and bring to justice those who fall short of legal compliance.

It’s important that all suppliers understand and follow the regulatory requirements around importing and distributing medicines and medical devices. If not, they could fail to meet our safety standards, endangering patient health.

While there is no evidence that these medicines posed a risk to patients, they had been stolen from hospitals in Italy before being imported from Egypt. This case illustrates that failing to comply with the regulations and conditions of the relevant licences can have serious consequences.

We will investigate any report of suspected illegal activity involving medicines and medical devices so that patients can be confident their medication and medical devices are acceptably safe.

[1] The medications the defendant did not have the correct licences for importing or distributing were: Avastin, Enbrel, Eylea, Faslodex, Herceptin, Humira, Kadcyla, Lucentis Neulasta, Nexavar, Opdivo, Perjeta, Soliris, Stelara, Sutent, Velcade and Xgeva. These are prescription-only medicines that are used to treat cancers, arthritis, and Crohn’s disease among others.

[2] Between 12 July 2017 and 9 June 2018, Wimpole Pharmacie Limited imported 4484 packs of various medicines, the total purchase price of which was £2,744,184 and sold them for £2,968,069, for a profit of £223,885.

[3] The European Economic Area includes EU countries as well as Iceland, Liechtenstein and Norway. It allows them to be part of the EU’s single market. For more information, see the gov.uk page

[4] On the first count of importing medicinal products contrary to regulations, he was sentenced to 20 weeks imprisonment suspended for twelve months and 100 hours of unpaid work. On the second count of distributing medicinal products contrary to regulations, he was sentenced to 20 weeks imprisonment suspended for twelve months and 100 hours of unpaid work, to be served concurrently. Therefore, he was sentenced to 20 weeks in total and 100 hours of unpaid work in total.




Inspection Report Published: An inspection of the use of hotels for housing unaccompanied asylum-seeking children March – May 2022

News story

This inspection examined the use of hotels to accommodate unaccompanied asylum-seeking children, with particular reference to the Home Office’s duty to safeguard and promote the welfare of children who are in the United Kingdom.

Vulnerable child

This inspection examined the use of hotels to accommodate unaccompanied asylum-seeking children, with particular reference to the Home Office’s duty under Section 55 of the Borders, Citizenship and Immigration Act 2009 to safeguard and promote the welfare of children who are in the United Kingdom.

Publishing the report, David Neal, the Independent Chief Inspector of Borders and Immigration (ICIBI), said:

It is clear that the housing of these extremely vulnerable children in hotels represents a significant challenge to the Home Office, in both ethical and operational terms. This is not an area in which the Home Office should be operating. A clear cross-Government approach is required.

The young people who spoke to inspectors all stated that they were happy and felt safe in the hotels, although the majority were keen to move on and resume their education. Inspectors found Home Office and contractor staff were, in the main, committed and engaged in their work and keen to provide the best possible environment for the young people in their care. However, this inspection did find areas of significant concern including two cases of staff who had not been Disclosure and Barring Service checked residing at hotels.

More broadly, while the initial crisis response had transitioned to a business-as-usual operation, the practices and procedures developed by the Home Office did not represent a child-centred approach that fully acknowledged and provided for the safeguarding and wellbeing needs of the young people in the department’s care. Similarly absent was consistent and effective oversight by the Home Office of contractor activity. Guidance, processes and policies were slowly being developed but this gap in clarity led to clear shortcomings in the provision of key services for these children.

Although staff referred to the need to end the use of hotels, there was little in the way of concrete planning for this to be achieved and no timelines provided by the Home Office.

As we found in the inspection into the processing of migrants at Tug Haven and Western Jet Foil, a disjointed response at day one or even week one could be excused but at month 10 this is not acceptable. Senior leadership action is needed to unlock the sub-optimal ownership of this issue in order that these children and those who will keep on arriving over the next days and weeks receive a more effective service. In essence, a recognition of the enduring nature of the requirement is needed.

I am particularly grateful for the expertise and assistance provided by Ofsted inspectors who accompanied my inspectors during the onsite phase of the inspection.

This inspection made four time-bound recommendations. The Home Office has accepted one recommendation and partially accepted three. I welcome the news that the Home Office has moved to a sole occupancy model which means members of hotel staff, including those without DBS checks, are no longer able to sleep or reside onsite. However, it is disappointing to note that the time-bound nature of the recommendations appears to be a barrier to full acceptance, that overall the pace of implementation appears slow and that processes necessary to ensure the safeguarding of children remain ‘in development’. This approach continues to ignore the vulnerability of these children.

This inspection report was sent to the Home Secretary for publication on 9 June 2022.

Published 19 October 2022




Crime news: updated digital Proceeds of Crime Act forms

News story

You can now download new versions of digital Proceeds of Crime Act claim forms PA1, PL1 and PL2.

Two people working on laptops

New digital POCA forms are available to download which include updated claiming rates.

The new forms can be used for all POCA claims, including those where a representation order has been made on or after 30 September 2022.

Important to use new forms

It is important to make sure that you are using the updated digital forms for your claims. This means downloading fresh copies of the claim forms when you submit new POCA claims.

You can download the forms from the GOV.UK website where you can also find guidance available to help with your claims.

Further information

POCA forms for solicitors and advocates

Published 19 October 2022




Call for bids: Building support for LGBTQ+ people in Romania

Deadline for submitting project bids is 1 November 2022.

The British Embassy Bucharest invites project proposals to support the delivery of activities and outcomes on building a supportive environment for the LGBTQ+ community in Romania. This is on behalf of a group of potential project sponsors, including the Embassy of Ireland in Bucharest.

This project is part of a wider British Embassy portfolio of projects which seeks to support the Romanian Government and civil society in promoting LGBTQ+ rights across the world. It also complements the work in this field being carried out by the other participating project sponsors.

Social acceptance of LGBTQ+ people in Romania remains limited, characterised mostly by ambivalence and a small, but vocal, negative response. There is some slow improvement, of attitudes but there remains significant misconceptions about LGBTQ+ people in public discourse, which would benefit from being dispelled and debunked.

The LGBTQ+ community struggles to gain acceptance amongst the wider population, despite quite a high level of social apathy towards the topic. In this context, we propose working with local LGBTQ+ NGOs to develop and promote a toolkit focused at allies of LGBTQ+ people. This would aim to break misconceptions and provide information and tools for those who wish to be more supportive of their LGBTQ+ relatives, friends and colleagues.

Objective

To promote a better understanding of LGBTQ+ issues for potential allies of LGBTQ+ people through building a more constructive public discussion around the LGBT+ community and promoting more inclusive social attitudes. This should include improving understanding for parents, colleagues, friends as well as broader society.

Scope of Work

The project should have a national reach, and should utilise online media where appropriate. It should also look to build long-lasting resources to be utilised beyond the immediate life of the project.

Activities

It is essential that the project implementer builds effective relationships to secure buy in at a policy and operational level for this project to be successful. Potential activities could include:

  • digital resources or platforms for allies
  • creative campaigns to promote positive social attitudes
  • a communications campaign to promote resources with appropriate target audiences
  • activities to promote resources and key messages with authorities, as appropriate

This is not an exhaustive list and the British Embassy welcomes innovative proposals from potential implementing partners that suggest additional or alternative activities to deliver the key objectives. We encourage creative proposals and ideas.

Project approach

The British Embassy Bucharest is working with the Embassy of Ireland in Bucharest, and other potential project sponsors, to enhance and secure further funding for the project. All future partners will be consulted and approve a project proposal.

This proposal will form the basis for project planning. The proposal should set out how the implementing partner will deliver activities to support the objectives set out above with an implementation plan and supporting activity-based budget.

The British Embassy Bucharest will oversee the project planning, in communication and coordination with other partners, and provide the necessary contacts to the implementers.

The project implementer will manage project logistics and is expected to consider the pandemic context and its possible impact on the project implementation when submitting the bid.

The project sponsors will provide contact persons and focal points for UK, Irish other national institutions or experts that might be needed in the process. The Embassy and partners will also aim to provide international best practice where possible and appropriate.

How to bid 

Our process will consist of a one-stage full bid proposal. 

Bids should be completed in English using the Project Proposal Bid Form For Implementers (ODT, 48.4 KB) and an Activity based budget template (ODS, 9.82 KB) should be submitted alongside it. The project sponsors reserve the right to request additional information from bidders before making a decision.

Activity Based Budgets should list the activities needed to deliver the outcomes (results) of the project and all costs should be in Romanian Lei (RON). 

Deadline for submitting project bids is 1 November 2022.

Please send all completed forms to bucharest.projects@fcdo.gov.uk and kim.best@fcdo.gov.uk.  

Please specify in the subject of the email: Name of implementing organisation and title of the project. 

Reporting

The reports to be produced during the course of this project are to be delivered in English:

  • an Inception Note detailing approach and proposed activities. This should also set out key stakeholders who will be engaged, a proposed schedule of activities, risks, safeguarding approach and any additional details, including a communications plan
  • a draft report
  • three monthly financial reports
  • after a facilitated process of commenting, the Final Report

Composition of the project teams:

The British Embassy Bucharest will nominate a Project Director, British Embassy Bucharest (Goran Mandic, 1st Secretary) and a Project Manager, (Kim Best, 2nd Secretary) to oversee the project delivery.

Project proposals should demonstrate that the implementing partner’s staffing levels are appropriate to deliver the aims of the project and that the staff have relevant expertise and experience in working with LGBTQ+ topics in Romania, as well as detailed knowledge of the situation of the LGBTQ+ community in Romania.

Timing and scope of input

The bidding round is an open and competitive process, assessed by the British Embassy in Bucharest, in coordination with the Embassy of Ireland and other partners. Results will be issued by late October. Once a bid is approved, a Grant Agreement will be signed with the successful bidders. In the documents section you will find an example of a Grant Agreement.

Your organisation will be expected to sign the contract within 1 week of the funds being awarded. Failure to do so may result in the funds being re-allocated. The implementing organisation will be required to submit report updates and a final evaluation of the project.

Most project funding will be available on a reimbursement only basis, with some scope for payments to be made in advance of work carried out. Reimbursements will be completed once activities have taken place and all receipts submitted.

For payment by reimbursement Implementing organisations will request repayments using an invoice (including receipts and a financial report of spend) and the repayments will be carried out during those dates agreed upon in the respective contract. The exact schedule of payments will be discussed and agreed with the successful project.

The budget should be presented in Romanian New Leu (RON). All payments will be made in RON to a bank account held in Romania.

Please send any questions regarding the call for bids to kim.best@fcdo.gov.uk.

It is expected that the project will be carried out from November 2022 to end March 2023. The crucial milestones will be the submission of the Draft report (February 2023) and the Final Report (April 2023).

Budget

Grant applications must include an estimated budget of at least 80,571 RON. The British Embassy Bucharest is offering 48,571 RON and the Embassy of Ireland is offering 32,000 RON. We will accept bids with scalable budgets, to allow for further funding from other potential partners.

Depending on the quality of the proposals, the British Embassy, Embassy of Ireland and other project sponsors reserves the right not to grant all or part of the available funds.

The Embassy also reserves the right to award a grant of less than the amount requested by the applicants. In such a case, applicants will be asked to increase the amount that they co-finance, to propose other co-financing means or to decrease the total costs without altering the substance of the proposal.




Pay It Forward: Investing in A Green Future

We don’t need to look back very far to see that we are now living with the very real impacts of the climate emergency. Here in the UK, this summer we experienced our highest ever recorded temperatures as the Met Office confirmed that England had its joint hottest summer on record.

Internationally, the reality is even bleaker: we saw wildfires raging across Europe; China experienced its worst heatwave in decades; and devastating floods in Pakistan ripped through communities killing 1500 people and displacing millions.

That 2015-2021 were the planet’s seven warmest consecutive years on record should tell us all that we need to know about our climate: that this is our new reality and that it’s time to start paying serious attention.

We also know what’s caused it. We can be in no doubt that the great advances in industry and technology since the industrial revolution have improved our lives immeasurably. However – as many have rightly pointed out – our reliance on greenhouse gas emitting technology has caused the climate to change to the point that we risk destroying the natural systems on which we all rely.

This has further led some to claim that capitalism is the enemy of the climate. That’s a highly contested point, and debating it isn’t going to get us very far. But what no-one can seriously dispute is that to accelerate the adoption of the innovation and technology required to address the climate emergency then unlocking massive private sector investment in a green future is essential.

Today I want to talk about why I think the private sector is the most powerful tool we have to meet the challenges of climate change. And that’s good news because tackling the climate crisis is not only the right thing for the planet, but also crucial for any business that wants to survive and thrive.

The solution: mitigation and adaptation

So, let’s continue on a positive note: we are seeing action. Internationally, last year’s COP26, the UN climate conference in Glasgow, saw significant pledges as countries came together to boost climate cooperation; commitments to stop deforestation; and a plan agreed by more than 100 countries to cut 30% of methane emissions by 2030. We can and should continue to expect governments to push this agenda forward, and at COP27 in Egypt next month we can expect further focus on how the public sector can commit to further unlocking the opportunities that green finance present.

At national level, in the UK we became the first major economy to make a legal commitment to achieving net zero emissions. This will mean getting to the point where we will be taking as much carbon out of the atmosphere as we are putting into it, and therefore are no longer contributing to climate change. Green technologies such as carbon capture and storage will have a key part to play here. And the new government has been clear that business investment and growth will be central pillars as we seek to reboot the UK economy.

As individuals we all have a part to play through our everyday choices: how we travel, what we eat, and how we spend and invest our money. That is a crucial opportunity for business, as consumers increasingly view their spending choices through a climate lens.

But there is another side to the climate coin – adaptation – because we are already living with the impacts of climate change. Adaptation is how we change the way we live in this reality: how we build, how we travel, how we work. Successful adaptation will only be possible through continued action by business, and through investment in the innovation and technology that this new reality requires.

Smart business: the role of the private sector

Looking back over the evolution of capitalism – from the UK as the “workshop of the world”, through the digital revolution, to the fourth industrial revolution – what we know is that successful business innovates. Smart business adapts and it disrupts; and businesses that fail to innovate will eventually fail.

And when it comes to the climate emergency, business is stepping up to the plate. In August I visited O.C.O Technology in the southwest of England to see the company’s technique that turns hazardous waste – which would have otherwise been sent to landfill – into a non-hazardous resource for use in construction materials. This process is net carbon negative – and production in one year is the equivalent of planting more than half-a-million trees.

Likewise, earlier this year Tata Chemicals opened the UK’s largest, and first industrial scale, carbon capture and usage plant located in Cheshire. Here, carbon dioxide captured from the combined heat and power plant is used in the production of sodium bicarbonate.

Meanwhile Gigastack are leading a project in the Humber to develop technology to produce green hydrogen, using renewable energy from one of Europe’s largest wind farms.

All of these businesses are expected to capture significant levels of carbon dioxide, through technologies that make sense not just for the environment but for business – innovating for green growth and adapting to support the fight against climate change.

Pay it forward: the opportunity

So why should businesses be doing this? I could just tell you that it’s the right thing to do. Because it is. But the truth is there are lots of reasons – I’ll draw your attention to three.

Reason one: risk. How and what businesses invest in is critical in influencing the impacts of climate on a global scale and helping businesses manage future risks. Example: in the UK we have felt the impact of climate change over the last few summers, through extreme flood and extreme heat events – data systems failed, railways buckled and the underground flooded. These events are going to become more common. Businesses must consider climate change as a risk to business continuity and climate resilience as a prudent investment in the good management of future risk.

Reason two: reputation. How businesses address these risks matters for their reputation. Businesses which can demonstrate a knowledge of climate risks and have a plan to mitigate them will appeal to shareholders, investors and the public. They will also attract talent: in a tight labour market where everyone is competing for the top talent, tackling the climate emergency is one of the biggest draws for young people. And the highest performing staff are increasingly driven by purpose.

Reason three: reward. It will make more money. That’s because adopting innovative, climate-resilient technologies and approaches mean greater efficiency; attractive, climate-smart products and processes mean greater demand; and greater resilience attracts investment and enhanced shareholder value.

And there’s a further reason right now why we should be encouraging all companies to invest in the kind of technology on show at this conference and a greener future: it’s the way to secure the growth, jobs and prosperity we all want.

The role of Green Finance

In 2019 the UK government set out its plans to green the financial system and make the most of the opportunity of the transition to a net zero, resilient economy, through the objectives outlined in its Green Finance Strategy.

And last year the government also published a Roadmap to Sustainable Investing, which set out a path to sustainable disclosures reporting. Consistent, defined disclosures will help provide a level playing field in environmental reporting and the information required to support decision making for businesses and investors. And so are vital to ensuring long term growth.

What is the Environment Agency doing on Green Finance?

The Environment Agency is a key player in this work on Green Finance.

We are working directly with government and business to advise on the frameworks and policies to support the transition to sustainable investment. Example: our scientific and technical expertise is being used to provide clear definitions to be included in businesses’ sustainable disclosures reporting. This means businesses can be confident of a level playing field, consumers can be confident that green really is green – and that those that are doing the right thing benefit from their investment.

We are also taking action on the ground. The Environment Agency and Defra have collaborated on the £10 million Natural Environment Investment Readiness Fund which has provided grants up to £100,000 to environmental groups, local authorities and businesses to help them develop nature projects that can attract private investment. These projects will help the private sector understand, invest in, and scale up activities that deliver better resilience to climate shocks in the years to come.

There is a simple reason why the Environment Agency is doing this: we have placed tackling the climate emergency at the heart of everything we do. We are working directly with the sectors we regulate to advise industry on how to decarbonise, reduce environmental risks and implement new technologies. We are helping businesses consider the future impacts of climate change on their operations to support the innovation which will drive economic growth.

Governments, businesses, NGOs cannot do this alone. We hope that by contributing to this work, in the future we will have a strong framework for how businesses, government and NGOs can work together to address the challenges of climate.

Conclusion

I remain what is these days becoming quite unfashionable: a climate optimist. This is because we are seeing change all over the world in how people think and act on climate. Whether that is on the international stage; through commitments made by individual governments; businesses investing in low carbon solutions; or the decisions we all take as individuals – because the climate is everyone’s business.

But it is the private sector that is the most important actor of all because it has the pace, power, resources and ability to innovate that are unmatched by other sectors. What businesses invest in can be a driving force in the fight against climate change and of a strong economy. By tackling the climate emergency, smart businesses are doing well by doing good.

British Prime Minister Margaret Thatcher was famous for her strong commitment to the free market. She is perhaps less remembered today for another strong stance she took. She was the first major world leader to call, at the UN in 1989, for action to tackle climate change. And she saw no contradiction between the capitalism she believed in so strongly and saving the planet. On the contrary, she made a powerful argument that only business and the free market could do that.

In that landmark speech in 1989, Mrs Thatcher said this:

“As well as the science, we need to get the economics right. That means first we must have continued economic growth in order to generate the wealth required to pay for the protection of the environment. But it must be growth which does not plunder the planet today and leave our children to deal with the consequences tomorrow.”

She was equally clear that the private sector is central to the solution: “It is industry which will develop safe alternative chemicals for refrigerators and air-conditioning. It is industry which will devise bio-degradable plastics. It is industry which will find the means to treat pollutants and make nuclear waste safe.”

More than thirty years after that landmark speech, we have made massive strides in recognising and starting to tackle the climate emergency. But the role of the private sector in doing so remains as critical now as it was then. As they say in Silicon Valley, the best way to predict the future is to invent it. I encourage all of you, and other businesses around the world, to invent the green and prosperous future we all want.