HDA UK Media And Political Bulletin – 31 March 2017
Safety Features Newsletter – March 2017
MHRA, 30 March 2017
In the March Safety Features Newsletter, the MHRA outlines the level of discretion inherent to the EU Falsified Medicines Delegated Regulation regarding different implementation options for the UK supply chain. A key area of flexibility is detailed in Article 23, with provisions which enable wholesalers to verify and decommission on behalf of groups of organisations who do not operate in a healthcare institution or within a pharmacy. Since the Delegated Regulation was published in 2016, the Falsified Medicines Directive (FMD) project team has been engaging with interested parties to identify a proposed UK solution which keeps costs and burden to a minimum whilst realising the benefits of FMD. To support FMD, the MHRA has also set up a dedicated mailbox for enquiries about implementing the safety features aspect at MD.firstname.lastname@example.org.
BIA explore options for working with EU post-Brexit
Manufacturing Chemist, 30 March 2017
The UK BioIndustry Association (BIA) is sending a UK delegation to Switzerland to see how the country’s biotech sector could work with the rest of Europe but outside of the European Union. Considering new relationships, BIA CEO, Steve Bates, said: “The UK and Switzerland make up a significant proportion of Life Sciences activity in the EU and there are many unexplored opportunities for collaboration and mutual learning”.
Further concessionary prices agreed for March
Chemist and Druggist, Grace Lewis, 30 March 2017
The Department of Health and National Assembly for Wales have agreed further concessionary prices for the following items for March 2017 prescriptions.
|Diamorphine||30mg||powder for solution for injection ampoules (5)||£16.52|
House of Commons, Written Answers, Thursday 30 March 2017
Daniel Zeichner, MP:
If his Department will provide a summary of the submissions made to NICE and NHS England consultation on changing arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s technology appraisal and highly specialised technologies programmes.
Department of Health
Nicola Blackwood, MP:
A summary of responses to the National Institute for Health and Care Excellence (NICE) and NHS England consultation on proposed changes to the arrangements for evaluating and funding drugs and other health technologies assessed through NICE’s technology appraisal and highly specialised technologies programmes can be found in the NICE Board papers, located at:
MHRA, 30 March 2017
Launch of the EMVO on-boarding partner portal
On-boarding of pharmaceutical companies to the European Hub is one of the major tasks being undertaken by the European Medicines Verification Organisation during 2017 and 2018; in total, some 2,500 entities across the EU are expected to register with EMVO for this process over the next two years. In order to expedite this task, EMVO launched an online portal, and offers guidance documents for potential on-boarders. Manufacturers and parallel distributors are encouraged to initiate this process as soon as possible in order to ensure that their systems are compliant in good time for the implementation of the Directive in February 2019.
An EMVO announcements section is now available with further information https://www.emvo-medicines.eu/announcements/. Contact with the EMVO may be made to the Commercial & Partner Management Team (email@example.com).
Article 23 Organisations
Within the Commission’s delegated regulation there is discretion in some specific areas to consider different implementation options for the UK supply chain. One of the these key areas of flexibility is detailed in Article 23 of the delegated regulation and provides provisions to enable wholesalers to verify and decommission on behalf of groups of organisations who do not operate in a healthcare institution or within a pharmacy. These groups of organisations include for example dental practitioners and optometrists, a full list of organisations can be found under Article 23 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf.
Since the delegated regulation was published in 2016 the FMD project team has been engaging with interested parties to identify a proposed UK solution which keeps costs and burden to a minimum whilst realising the benefits of FMD. As part of this process of engagement for ‘safety features’ the Government will be launching a public consultation shortly to gather views on how best to implement the regulation. The Article 23 flexibility will be one of key areas of the public consultation where the government has legal scope for change and on which everyone affected can influence the proposed approach to implementation.
Other resources available
The ABPI provide an open website of resources and links on the Falsified Medicines Directive and the Delegated Regulation on ‘Safety Features’. This website includes past copies of MHRA newsletter.
Mailbox for FMD enquiries
Please contact us at FMD.firstname.lastname@example.org
As part of our stakeholder engagement work we have set up a dedicated email mailbox to receive enquiries about the implementation of the safety features aspect of the Falsified Medicines Directive. The mailbox is monitored daily and you can expect to receive a response within 5 working days. If you don’t currently receive a copy of the newsletter and would like to, please email by return with the following – your name, your organisation (if applicable) and your title (if applicable).
Manufacturing Chemist, 30 March 2017
The UK BioIndustry Association (BIA) is leading a UK delegation from the biotech sector on a discovery trip to see how Switzerland works with Europe but outside of the European Union, to forge new relationships and explore potential opportunities.
Switzerland has a very different political system to the UK with a lot of decentralised power across the 26 cantons, which have some autonomy regarding issues that have an impact on the industry, such as regulation and taxes.
Learning about such a different way of operating offers potential lessons that the UK could explore in the future.
BIA CEO, Steve Bates, said: “The UK and Switzerland make up a significant proportion of Life Sciences activity in the EU and there are many unexplored opportunities for collaboration and mutual learning.”
“Exploring the sector in Switzerland will help the UK to learn lessons that could help support the Brexit negotiations process throughout the next two years.”
Ted Fjallman is Executive Director of Tekiu, a knowledge transfer, VIP technical visits, policy engagement, workshop facilitation and science communication company.
He said: “Often, all the representatives would only meet once or twice a year. This visit will allow them to experience things together.”
The delegation will look at the range of tax incentives there are to encourage growth and build an understanding of how important the low tax environment has been for biotech investment in Switzerland.
Representatives for the UK will also meet a cross section of Swiss companies from SME’s such as Zurich based NeurImmune, to larger organisations Biogen, Shire and Novartis.
From Factory to Pharmacy
As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.See the Infographic
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