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HDA UK Media And Political Bulletin – 1 June 2017

Media Summary

New EMA guidelines on biosimilar medicines
European Pharmaceutical Review, Niamh Marriott, 1 June 2017 

The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars. The guide was launched at the European Commission’s stakeholder event on biosimilar medicines – a discussion forum bringing together stakeholders interested in biosimilars including healthcare professionals, patients, payers, regulators and industry. The guide can be read here.

 EPS behind some of the most common dispensing errors
Chemist and Druggist, Grace Lewis, 31 May 2017

The electronic prescription service (EPS), refrigerated drugs, and monitored dosage systems (MDS) have all been linked to some of the most frequently reported dispensing errors of 2017 so far. The National Pharmacy Association’s (NPA) latest medication safety officer report in April noted the high level of errors involving EPS, including failures to clarify doses and failure to “write out abbreviations appropriately on the dispensing label”. The overall number of error reports increased by 45% between January and March, compared to the previous three months, the NPA noted. The NPA reminded pharmacists not to rely on EPS systems to label items correctly.

Expats returning post Brexit could cost NHS £500m
Pharma Times, Selina McKee, 31 May 2017

The NHS could face having to pay nearly half a billion pounds more if British expats decide to return to the UK because their right to healthcare in EU countries is withdrawn after Brexit. A new briefing paper by The Nuffield Trust warns that care homes and home-care agencies in particular could struggle, with a potential shortage of 70,000 staff by 2025/26 if migration of unskilled workers from the EU is halted.

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Expats returning post Brexit could cost NHS £500m
Pharma Times, Selina McKee, 31 May 2017

The NHS could be faced with having to pay nearly half a billion pounds more if British expats decide to return to the UK because their right to healthcare in EU countries is withdrawn after Brexit.

According to a new briefing paper on the potential impact of exiting the EU by think-tank The Nuffield Trust, the cost of treating expat pensioners on the NHS in the UK rather than abroad could potentially double.

Currently around 190,000 British pensioners live in other EU countries and receive healthcare under the EU reciprocal ‘S1’ scheme. Should they return to the UK post Brexit if this benefit is withdrawn, the cost to the NHS is likely to be around £979 million, around twice the amount that the government currently reimburses for their care.

Also, the report says the figure could be “substantially higher” if the NHS has to pay to replace staff if EU migration is reduced, or if it faces a rise in the cost of medicines, and warns that care homes and home-care agencies could end up as many as 70,000 staff short by 2025/26, if migration of unskilled workers from the EU is halted.

Around 900 extra beds would be likely to be required if this number of British pensioners returned, but the briefing argues that, unlike funding, beds and staff cannot simply be brought on-stream at will.

On the plus side, there is still the scope for a funding boost for the UK when it stops paying its EU membership fees, which could give the NHS additional money for one or two years, it notes.

“It is possible that extra funds could be found for the NHS from any cancellation of Britain’s EU membership fees – but whether or not these benefits will outweigh the significant staffing and financial costs Brexit may impose on already stretched services remains to be seen,” noted Mark Dayan, policy and public affairs analyst at the Nuffield Trust.

“That depends largely on the NHS being recognised as a significant priority as we enter some of the most important negotiations in Britain’s history”.

New EMA guidelines on biosimilar medicines
European Pharmaceutical Review, Niamh Marriott, 1 June 2017

The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that are highly similar in all essential aspects to a biological medicinethat has already been authorised.

The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.

“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said Professor Guido Rasi, EMA’s Executive Director.

The guide is a joint initiative of EMA and the European Commission. It was developed in collaboration with EU scientific experts, in response to requests from healthcare professionals. Organisations from across the EU representing doctors, nurses, pharmacists and patients have also shared useful views, to ensure that the guide adequately addresses questions relevant to healthcare professionals.

The guide was launched today at the European Commission’s third stakeholder event on biosimilar medicines, a discussion forum that provides a platform for stakeholders interested in biosimilars, including healthcare professionals, patients, payers, regulators and industry.

Presenting the guide at the launch, Dr Juan Garcia Burgos, head of EMA’s Public Engagement Department emphasised that “this comprehensive reference material is a joint effort to support information and continuous education of healthcare professionals in the EU, and facilitate dialogue with patients.”

The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally.

Since the EU approved the first biosimilar in 2006, the evidence gained from clinical experience shows that biosimilars approved in the EU are as safe and effective in all their approved indications as other biological medicines. To date, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 28 biosimilars for use in the EU.

HDA UK Media And Political Bulletin – 1 June 2017

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