Environment Agency state aid exemption from the European Commission relating to a grant for remediation of a West Midlands contaminated site.

The UK thanks the Fact Finding Mission for its continued commitment to documenting the appalling events that have taken place in Myanmar since 2017, in particular targeting the Rohingya Muslims.

The Mission’s reports paint a devastating picture of systematic human rights violations and a culture of consistent impunity in Myanmar. They have also shown how this is reinforced by economic structures that exist to protect and enrich those responsible.

From human rights violations in Rakhine, Shan and Kachin States; to the insidious nature of the Tatmadaw’s economic influence; or the horrific sexual violence perpetrated by the security forces; the need for genuine accountability has never been clearer. The Independent Investigative Mechanism for Myanmar has our full support as it becomes operational, and we encourage Myanmar to cooperate fully with its mandate.

Accountability for the atrocities documented by the Fact Finding Mission is crucial. A credible domestic process would be the most effective route to justice and reconciliation. We call on the Independent Commission of Enquiry to demonstrate its independence and credibility and we await its report. However, if domestic processes are not credible then we must look at all other options.

We believe that the situation in Myanmar continues to warrant the attention of the international community, both in the Human Rights Council and in the Security Council.

Mr. President, what can the Investigative Mechanism learn from the Fact Finding Mission to ensure it is as effective as possible?

Smaller companies often struggle to convert their game-changing ideas into commercially available products and services because of the costs of scaling up production and the difficulty in gaining finance.

Innovate UK as part of UK Research and Innovation is offering up to £10 million in loans to help small and medium-sized companies (SMEs) to commercialise innovative products or services.

Ideas can come from any area of technology or the economy and must lead to sustainable business growth.

The scheme aims to provide businesses with finance that is affordable and flexible and that supports projects in the late stage of development.

Businesses must have developed a game-changing idea

The aim of the competition for innovation loans is to help businesses to overcome the barriers to their cutting-edge ideas becoming sustainable commercial products. Businesses need to show they could not get suitable finance from other sources.

Applicants must demonstrate:

• a clear game-changing and/or disruptive idea
• a strong and deliverable business plan
• the necessary skills and experience to run and complete the project successfully and on time
• awareness of all the main risks the project will face
• sound, practical financial plans and timelines that represent good value for money
• a clear plan to deliver growth through commercialisation

Competition information

• the competition opens on 23 September 2019, and the deadline for applications is at midday on 27 November 2019
• only SMEs can apply
• loans of between £100,000 and £1 million are available
• projects can last up to 5 years and the loan can be repaid over up to 10 years

Published 17 September 2019

In advance of World Patient Safety Day (17 September), MHRA specialists, as part of a broader programme of work, have begun developing ground-breaking research to support the safer use of medicine during pregnancy.

A $360,000 grant over two years from the Bill & Melinda Gates Foundation (approximately £292,000), will support the MHRA’s research, to help predict the need for adjusting a medicine’s dose during different trimesters of pregnancy. This will ensure effective use, which is vitally important for the health of mother and baby.

Worldwide, data in this area remain limited, and new insights could potentially impact the health of pregnant women around the world. This would also give obstetricians further clarity on the optimal dose of a medicine, when treating pregnant patients, for whom use of a medicine is necessary.

When pregnant or breastfeeding, it is generally recommended to avoid the use of medicines, although more than half of all pregnant women consume at least one medicinal product during their pregnancy.

Medicine use can be essential to safeguard the health of mother and baby. This includes treating existing conditions such as diabetes, epilepsy or cardiovascular conditions. However, for many medicines, unless indicated for use during pregnancy, the best regimen and dosage levels during different stages of pregnancy are largely unknown.

It is also difficult to predict whether doses of medicines, which are effective during early pregnancy, will produce their desired effect at a later stage. In this research, MHRA specialists will use prediction models to develop recommended medicine dosages for pregnant women in the UK. This includes evaluating existing models— known as physiologically based pharmacokinetic (PBPK) models and simulations to develop a full picture for all stages of pregnancy.

The Agency will also provide training for healthcare professionals on how to use the models, and there will be a dedicated web portal.

The portal will host MHRA research on the effects of physiological changes which occur during pregnancy, and their impact on medicine exposure. The results of model predictions will also be available on the portal, allowing the opportunity for different research groups to upload and share their modelling, turbo-charging developments in this area.

Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA said:

“Patient safety is our highest priority and we are determined to support innovation in this important area, which helps improve the quality of health for pregnant women in the UK and internationally.

“This work provides a valuable launch pad for new developments into, and improved understanding of how pregnancy affects medicine levels. That’s why we are encouraging healthcare professionals, research groups and those looking to supply medicines during pregnancy, to make full use of the prediction models, data and resources we will provide.”

Trevor Mundel, President of Global Health, Bill & Melinda Gates Foundation said:

“We’re excited to play a part in the work that MHRA is doing around maternal health. We hope the innovative use of computer-aided modelling will help make medicine use safer and more effective for pregnant women around the world. We are dedicated to improving the quality of people’s lives and look forward to the outcome of new developments in this area.”

Notes to Editors

1. PBPK modelling is a technique for predicting the absorption, distribution, metabolism and excretion (ADME) of synthetic or natural chemical substances in humans and other animal species.
2. PBPK modelling is undertaken using a software used in computer-aided modelling, which the MHRA research will involve.
3. As pregnancy advances, there are considerable physiological changes in the woman over the three trimesters, leading to clinically important changes in absorption, distribution, metabolism and elimination of medicines.
4. Nausea and vomiting and alterations in gastric pH and GIT motility during pregnancy may alter medicine absorption; increased cardiac output and intestinal blood flow may increase absorption.
5. It is essential for clinicians to be aware of the pregnancy-related changes in PK and/or PD and to critically examine the potential clinical implications of these changes for a pregnant patient and the dosage of a medicine she may need.
6. The [Medicines and Healthcare products Regulatory Agency](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
7. The MHRA also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.

The United Kingdom thanks the Special Rapporteur for her update. We regret that her ability to discharge her duties continues to be challenged. We call on the Government of Myanmar to cooperate fully with her mandate and grant her full access.

We remain deeply concerned by the escalation of violence in Rakhine, Shan and Kachin states. We call on all parties to the conflicts to de-escalate hostilities, engage in meaningful dialogue, and protect civilians.

We welcome Bangladesh’s commitment to ensure that repatriations are voluntary and are conducted in coordination with UN agencies. We agree with the UN High Commissioner for Refugees (UNHCR) that conditions in Myanmar are not conducive to ‘safe, voluntary and dignified’ returns. We call on Myanmar to grant UN agencies full access to Rakhine.

Accountability for human rights violations in Myanmar is a key step towards reconciliation which is essential for long term stability. A domestic process remains the best hope for accountability in the near future but if that process is not credible nor independent then international processes remain on the table. We regret that the Independent Commission of Enquiry (ICOE) is yet to deliver its report. We strongly welcome the operationalisation of the Independent Investigative Mechanism for Myanmar (IIMM) and we encourage the ICOE to engage with it. Ms Lee, in your view, what are the main barriers to the ICOE releasing its report?

How can we ensure that the IIMM has the flexibility to deliver effectively on its mandate?

Published 17 September 2019