News

HDA UK Media And Political Bulletin – 4 May 2017

Media Summary

United Kingdom’s withdrawal from the European Union
The European Medicines Agency, 3 May 2017

The European Medicines Agency (EMA) and the European Commission have published a notice to marketing authorisation holders of centrally authorised medicines to remind them of their legal obligations in preparation for Brexit. Discussions have been initiated with the national competent authorities on how work related to the evaluation and monitoring of medicines will be shared between Member States. This is currently based on a scenario foreseeing that the UK will no longer participate in the work of EMA and the European medicines regulatory network as of 30th March 2019. The EMA announcement can be found here.

Medical Devices and CE Marking and the Impact of Brexit
Institution of Mechanical Engineers, 3 May 2017

The Institution of Mechanical Engineers have urged British Brexit negotiators to settle parallel policies for device approvals. They also urged the industry and NHS to maintain their influence over EU devices regulations. The report highlights the challenge of extricating the UK from the EU without the Medical Technology industry suffering. Recommendations include negotiating a Med Tech compliancy arrangement with the EU to ensure continuity in the Conformité Européene (CE) marking process for UK manufacturers, and removing the current funding imbalance between early-stage start-ups and large established companies in order to support research and innovation in the UK.

New legislation passed to prevent excessive price hiking of generic drugs
The Pharmaceutical Journal, 3 May 2017

A new law which aims to bring stricter price control to unbranded generic drugs has received Royal Assent in the House of Commons. The Health Service Medical Supplies (Costs) Act gives the UK Government the power to instruct pharmaceutical companies to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging “unreasonable” prices for generics. Manufacturers could face financial penalties if they fail to comply with the new law.

Report illicit drug harms: Pilot reporting site set up in response to soaring illicit drug use
Dispensing Doctor, Alisa Colquhoun, 4 May 2017

Public Health England is piloting a Yellow Card-type scheme for reporting adverse effects associated with illicit drugs. The site enables healthcare professionals to report illicit drug reactions (RIDR) and aims to collect data on the acute and long-term harm to health associated with the use of the drugs and potential interaction with licensed medicines. The reporting site will be available until mid-March 2018. Suspected interactions between licensed medicines and illicit drugs should also be reported via the Yellow Card scheme

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

United Kingdom’s withdrawal from the European Union
The European Medicines Agency, 3 May 2017

On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU). The implications of Brexit for the European Medicines Agency’s (EMA) location and operations depend on the future relationship between the UK and the EU, which is unknown at present.

No Member State has previously decided to leave the EU, so there is no precedent for this situation.

The Agency is in close contact with the EU institutions and national competent authorities in the EU Member States. EMA will share information on the latest developments with its stakeholders.

EMA’s ongoing mission

The Agency, its 890 employees and all the European experts contributing to EMA’s work will continue to focus on EMA’s mission to protect human and animal health and ensure access to medicines that are safe, effective and of good quality.
EMA’s procedures are not affected by Brexit. The Agency will continue its operations, in accordance with the timelines set by its rules and regulations.

The European medicines regulatory network as a whole is a very strong and flexible system that is able to adapt to changes without jeopardising the quality and effectiveness of its work.

Regulatory preparedness (new)

On 2 May 2017, EMA and the European Commission published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexit:

Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use

In April 2017, EMA initiated discussions with the national competent authorities on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK’s withdrawal from the EU.

This is currently based on a scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory network as of 30 March 2019.

Decision on EMA’s location

The location of the Agency after Brexit will depend on the future relationship between the UK and the EU, which is unknown at present. Representatives of the Member States will determine the Agency’s location by common agreement.
EMA welcomes the interest expressed by some Member States in hosting the Agency in future.

EMA is confident that the Member States will make the most appropriate decision on the Agency’s location and arrangements, taking the complex political and legal environment into account.

New legislation passed to prevent excessive price hiking of generic drugs
The Pharmaceutical Journal, 3 May 2017

A new law which aims to bring tougher price control to unbranded generic drugs received Royal Assent in the House of Commons on 27 April 2017.

The Health Service Medical Supplies (Costs) Act gives the government the power to instruct pharmaceutical companies to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging “unreasonable” prices for generics.

Manufacturers could face financial penalties if they fail to comply with the new law.

The government has traditionally relied on the market to keep generic costs down but in cases where there is no competition, prices have been hiked, according to the Department of Health briefing paper on the new legislation.

The intention is for the department to work with industry representatives and the Competition and Markets Authority to determine when a price is “unreasonably high”. The new legislation will also give the government more powers to collect information about the sale of drugs.

The Health Service Medical Supplies (Costs) Act was among a raft of bills which were granted Royal Assent on 27 April, before the dissolution of Parliament on 3 May 2017 ahead of the 8 June 2017 UK general election.

Report illicit drug harms: Pilot reporting site set up in response to soaring illicit drug use
Dispensing Doctor, Alisa Colquhoun, 4 May 2017

Public Health England is piloting a Yellow Card-type scheme for reporting adverse effects associated with legal highs and other illicit drugs.

The site enables healthcare professionals to report illicit drug reactions (RIDR) and aims to collect more detail on the acute and long-term harm to health associated with the use of the drugs and potential interaction with licensed medicines.

NHS Digital reports that hospital admissions for poisoning by illicit drugs are up by more than 50 per cent in a decade. Illicit drug use is said to be particularly prevalent in rural areas.

The reporting site will be available until mid-March 2018.

Suspected interactions between licensed medicines and illicit drugs should also be reported via the Yellow Card scheme.
The website also details where healthcare professionals can find out more information about legal highs.

HDA UK Media And Political Bulletin – 4 May 2017

From Factory to Pharmacy

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