News

Media and Political Bulletin

20 October 2017

Media Summary

MHRA Inspectorate Blog, Mark Birse, 19 October 2017

This blog post highlights that the MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries. The MHRA reports that in the last few years they have had an increasing number of trade associations and individual companies approach them when the outcome of an inspection in the UK, conducted by an international inspectorate, has differed from the company’s own expectations.

From now on, the inspectorate requests that UK companies inform inspectionplanning@mhra.gov.uk if they are hosting an inspection from another medicines regulator.

Parliamentary Coverage

Tom Brake MP: To ask the Secretary of State for Health, what assessment his Department has made of the potential effect on the supply of medical devices to NHS patients in the event that there is no transitional period prior to the UK leaving the EU during which to implement changes in EU law made before or during such a transitional period.

Department of Health
Philip Dunne, Minister for Health: The Medicines and Healthcare products Regulatory Agency, the Office of Life Sciences, and the Department for Exiting the European Union are leading our work in this area.

Medical devices are important for transforming health outcomes, and our top priority for the Life Sciences sector in the negotiations is to protect the safety of patients and ensure the integrity of cross-European public health systems.

After the European Union referendum, the UK EU Life Sciences Steering Group was established to oversee a programme of work that is informing our departure from the EU. The group’s remit includes people and skills; research and grants; intellectual property; regulation and trade, manufacturing and supply – to organisations including the National Health Service.

Regarding potential transposition of any changes in EU law, the general approach taken in the European Union (Withdrawal) Bill is that EU law which applies directly in the UK legal system immediately before exit will be converted into domestic law after exit. The purpose of the Bill is to provide a functioning statute book on the day we leave the EU, and it is designed to ensure that the United Kingdom exits the EU with certainty, continuity and control. After we leave the EU, Parliament will be free to change the law where it decides it is right to do so.

In the negotiations the Government will discuss with the EU and Member States how best to continue to cooperate. We start from the position of having an aligned regulatory partnership and any changes should consider the impact on patient and public health. However, we appreciate that this is a negotiation, so we are prepared for all eventualities. Whatever the outcome we will protect the best interests of patients and the NHS.

House of Lords, Drugs: Manufacturing Industries, 18 October 2017

Lord Laird: To ask Her Majesty’s Government what assessment they have made of the role of manufacturers of medical products in restrictions of supply to pharmacists, and of the relationship of such restrictions to the pricing of those products.

Department of Health

Lord O’Shaughnessy, Parliamentary Under-Secretary for Health: No such assessment has been made. However, the majority of products supplied through restricted wholesale models are branded medicines, for which prices are controlled by the Pharmaceutical Price Regulation Scheme. The Department, Medicines and Healthcare products Regulatory Agency, and pharmaceutical supply chain stakeholders agreed best practice guidelines for dealing with supply and distribution of medicines. These set out that where restricted wholesale models are in place, manufacturers should put contingency arrangements in place so that pharmacies can obtain the product directly from the manufacturer if they cannot get it from their wholesaler.

Full Coverage

MHRA Inspectorate Blog, Mark Birse, 19 October 2017

The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.

Notifications and observing

Whilst it is standard practice for the MHRA to notify national regulators when we perform overseas inspections in their country, the reverse of this is not as robust.  We do get notifications from many of our regulatory partners, but not from all.

Often our overseas inspections are observed by the national regulator of the country we are inspecting in and we also on occasion observe inspections that are being undertaken in the UK.  This helps to build confidence in the international regulatory network, in turn facilitating information sharing and more effective use of risk based inspection.

Is this an issue?

Over the last few years we have had an increasing number of trade associations and individual companies come to us where the outcome of an inspection in the UK, conducted by an international inspectorate, has differed from the company’s own expectations.

From discussions internationally the accuracy of registration dossiers and variations is a key component of many of these inspections.

Anecdotally we have heard of instances across the European network where the local regulators presence has been cited as helpful by both parties.

Risk based inspections

You’ll be well aware that we have a risk based inspection programme within the Inspectorate and outcomes from these inspections within the UK can also be used to support our inspection frequency

Informing MHRA

Going forward the MHRA Inspectorate requests that UK companies inform inspectionplanning@mhra.gov.uk if they are hosting an inspection from another medicines regulator.