Tag Archives: HM Government

Introduction

It is an honour to represent the UK at this ASEM Foreign Ministers’ meeting. It is a particular pleasure to see a democratically-elected leader of Myanmar in the Chair.

Myanmar’s path towards peace and democracy has been long and difficult. Major challenges remain. The UK is proud to have been a consistent advocate for human rights and democracy in Myanmar over many years. We continue to work with the civilian government to promote peace, sustainable development and fundamental rights for all communities in Myanmar.

We are particularly grateful to you, Madam Chair, for your willingness to address the issue of Rakhine in the margins of this meeting. We welcome your inclusive vision for Rakhine and commitment to the right of return for refugees.

I would also like to pay tribute to the generosity of Bangladesh for taking in more than 610,000 refugees over the past 3 months – a huge burden for any country. The UK has given some £47 million in humanitarian support and we stand ready, along with others here, I trust, to contribute further.

UK-Asia

The UK’s links with Asia run deep. They include some of our closest commercial, political and people-to-people links. As we prepare to leave the European Union, our commitment to ASEM and to Asia will endure.

Rules-based System

ASEM brings together countries with a deep commitment to the rules-based international system. Peace and sustainable development in both our regions depend on that system. So I want to highlight two threats to the rules-based system, and four global challenges that can only be addressed through strengthening that system.

North Korea

As many have mentioned, the first regional issue is the threat posed by North Korea‘s reckless nuclear and ballistic missile tests. The unanimous Security Council vote to strengthen sanctions sent the strongest possible signal of international resolve.

We all have a duty to enforce UN sanctions urgently and rigorously.

South China Sea

The second regional issue concerns the South China Sea. We are committed to a Rules-Based Maritime order. European states have a legitimate interest in peace, stability and security even as far away as the South China Sea. The UK’s position remains that all states must respect international law, as reflected in UNCLOS, and seek to settle disputes peacefully, without coercion or the threat of force.

Global Challenges

Turning to the global challenges:

The UK has shown that it is possible to cut emissions while pursuing economic growth. And I hope others will be abe to follow that lead. The Illegal Wildlife Trade not only harms biodiversity but also fosters corruption and undermines the rule of law. I congratulate China on its domestic ivory ban, and Vietnam for hosting the 2016 conference. London hosts the next conference on this issue in 2018. I urge ASEM to support work to combat this criminal trade.

Finally, digital connectivity can and will help enhance the links between Asia and Europe. The internet is increasingly a principal driver of our prosperity and social wellbeing. To ensure this continues, we must work together to tackle cyber-crime, protect online freedoms and abide by the norms of responsible state behaviour. Innovation, R&D will also ensure cyber security for us all.

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From 20-24 November, MHRA is running a social media campaign to promote recognition and reporting of suspected side effects from over-the-counter medicines, as part of an EU-wide awareness week.

While medicines are safe and effective, side effects can happen, even with over-the-counter medicines. It is important the risks associated with all medicines are understood and communicated to health professionals and patients.

Potential side effects may range from a headache or sore stomach, to flu-like symptoms or just ‘feeling a bit off’ and reporting these can help regulators monitor medicines on the market and take action as appropriate.

Regulators such as MHRA rely on the reporting of suspected side effects to make sure medicines on the market are acceptably safe. Unfortunately, all reporting systems suffer from under reporting – this is why our campaign is important to both raise awareness and help strengthen the system.

SCOPE ADR Campaign

Mick Foy, Group Manager for MHRA’s Vigilance and Risk Management of Medicines division, said

The most important part of our work is making sure the medicines you and your family take are effective and acceptably safe.

Our campaign will help the public, patients and healthcare professionals report potential side effects and have confidence that their reports are making a difference.

You can help make medicines safer by reporting any suspected side effects easily and quickly online through the Yellow Card Scheme.

The campaign is part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project. One of its main aims is to raise awareness of national reporting systems for suspected side effects in medicines.

Notes to Editor

1. National reporting systems for the collection of suspected adverse drug reactions (commonly known as side effects) have acted as early warning systems to help identify numerous important safety issues, many of which were not recognised as being related to a particular medicine until reports were received by medicines regulators.

2. The Medicines and Healthcare products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The agency consists of three centres: CPRD, NIBSC and MHRA.

3. The public is advised that they should take prescription-only medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.

4. To report a counterfeit medicine or device contact MHRA’s dedicated 24-hour hotline on 020 3080 6701, or email counterfeit@mhra.gov.uk, or write to: Counterfeits, The Intelligence Unit, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ.

5. To report a suspected side effect from an unlicensed medicine visit the Yellow Card Scheme

6. The SCOPE Joint Action project (scopejointaction.eu) social media campaign is being taken forward through the Heads of Medicines Agencies Working Group for Communications Professionals.

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The legislation making these changes was laid in Parliament on 16 November 2017.

These changes follow on from our consultation, which received comments from 23 respondents.

As explained in the government’s response document, we have adjusted the proposals in light of the comments we received. The legislation makes the changes set out in the response document.

We will publish detailed guidance on how these fee changes will operate in practice, in due course.

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Upcoming reforms to medical radiation exposure regulations will greatly change how the Administration of Radioactive Substances Advisory Committee (ARSAC) issues approvals.

The Ionising Radiation (Medical Exposure) Regulations 2018 (IR(ME)R) will come into force in England, Scotland and Wales on 6 February 2018. A separate set of regulations applying the same licensing process will be introduced in Northern Ireland.

The new regulations will replace the current certification process for the administration of radioactive substances under The Medicines Administration Radioactive Substances 1978 Regulations, and lead to changes in the way ARSAC handles applications.

There will be a double licensing system for practitioners and employers under IR(ME)R. The new system aims to make clear the responsibilities of the employer and practitioner in administration of radioactive substances.

The deadlines for receiving applications for certification are:

• 20 December 2017 for new and additional diagnostic or therapeutic applications
• 16 January 2018 for renewal diagnostic or therapeutic applications
• 16 January 2018 for new and extensions of research site certificates

Louise Fraser, Scientific Adviser to ARSAC, said:

It’s really important that you think about what these changes could mean to you and your employer and consider what, if anything, you need to do ahead of the changes. We will be preparing further guidance and will, as ever, be on hand to assist with any queries anyone may have about the interim and new arrangements.

For more information on next steps and regular updates on deadlines please subscribe to the ARSAC email bulletin.

Under the new regulations:

• employers must hold a licence at each medical radiological installation, such as a hospital or mobile imaging service, where radioactive substances will be administered for diagnosis, treatment or research – this licence will define the range of service that can be delivered at that location
• practitioners, such as nuclear medicine physicians, must hold a licence to clinically justify exposures involving the administration of radioactive substances for diagnosis, treatment or research; a practitioner’s licence is valid anywhere they are allowed under IR(ME)R 2018 to act as a practitioner
• a practitioner will only require one licence, regardless of how many employers they work for; the scope of the licence will reflect the individual’s training and experience for procedures
• any radiation exposure involving the administration of radioactive substances at a medical radiological installation must be justified by a licensed practitioner whose employer holds an appropriate licence for that exposure, at that installation
• entitled operators can continue allowing exposures in line with justification guidelines issued by a licensed practitioner entitled at that medical radiological installation
• any current ARSAC certificates due to expire after the new regulations come into force will be considered as equal to a licence for both the practitioner and the employer until the expiry date

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I am absolutely delighted to be taking up my new role. Our remit is extensive. There are, of course, challenges and opportunities for employers, schools, training providers and academies. We are not just a funding agency – our portfolio is also about supporting citizens, schools and businesses to make informed choices about apprenticeships, skills, learning, work and careers. If we can harness the power and capability of the sector, working with our partners, we can continue to make an impact on boosting economic growth while creating opportunities for social mobility.

We stand at a crucial moment in time. Seven months into the apprenticeship levy, which has brought about much change, the sector has quickly adapted. However, I am aware there are challenges. I am keen to work with the sector as a priority to ensure continued delivery and support as we implement the apprenticeship and devolution reform requirements ahead.

There is more work to be done on understanding the needs of our providers and employers, so they understand the investment opportunities the apprenticeship levy brings and more work to be done towards the national funding formula implementation for schools. All this encompassed by the need for a relentless focus on value for money for the taxpayer.

I have already been impressed at the work, achievements and commitments of the sector, including the ambition and pride in what continues to be delivered on a daily basis. I very much look forward to meeting and working with you all in the future.

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