NOAH represents the UK animal health industry. Promoting the development and use of safe, effective, quality medicines for the health and welfare of

Transcription

1 Catherine Sayer

2 NOAH represents the UK animal health industry. Promoting the development and use of safe, effective, quality medicines for the health and welfare of all animals

3 Role of NOAH Represent 90% of UK animal medicines market; value circa 625m+ Corporate Member = UK Marketing Authorisation Member of EU & global animal health associations

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5 The Animal Medicines market

6 NOAH Brexit Task Force NOAH Board formed Brexit Task Force The purpose to consider and advise the NOAH Board of Management on the impact of the UK exit from the EU for NOAH and its member companies. To include recommendations for preferred regulatory models, to identify particular risks and opportunities for the association and its members and to support NOAH in influencing UK government and others. Representatives from companies with HQ in EU, outside EU, in UK CEOs and people with tech/reg/comms expertise

7 NOAH Brexit priorities 1 Support trade & innovation Safeguard animal health & welfare, public health, food safety Ensure UK vets and animal keepers have access to a wide range of appropriate veterinary medicines Access to skilled staff concerns about our people, facing the loss of skilled EU experts from the UK. For businesses to thrive we need a correctly skilled workforce

8 NOAH Brexit priorities 2 New EU Veterinary Medicines Regulation will deliver significant reductions in administrative burden & improved protection of technical documentation critical in encouraging innovation- UK industry must not lose out on these improvements Avoid unnecessary additional regulatory burdens which may discourage companies from doing business in the UK

9 Day Zero Issues NOAH members identifying key day 0 issues that will arise on the very first day of Brexit Aim is to try and ensure business continuity Try to prevent unnecessary regulatory burden leading to lack of access to veterinary medicines and health and welfare problems

10 Day Zero Issues MA Holder based in the UK-Current legislation provides for a MAH to be established in any one of the Member States of the EEA. If that MS is no longer part of the EU or the EEA then it appears it cannot act as MAH for any other countries MAs. MAs may need to be transferred to a legal entity of that company in another MS of the EEA- significant impact on the companies concerned where the SPCs and product literature must change.

11 Day Zero Issues Manufacturing in the UK Consideration and transition plans needed where manufacturing/eu batch release is carried out in the UK; Batch release for the EU market of locally manufactured product Batch release for the EU market of material manufactured outside of the UK, but currently released in the UK for the EU

12 Day Zero Issues Many companies also produce feed additives, such as coccidiostats- NB for poultry health and welfare. Assessed and authorised for use by the European Food Safety Authority (EFSA). New process for authorisation of new products, as well as existing products, may need to be developed for UK market-no equivalent national assessment body in the UK currently Don t want to re-apply for authorisations for products that have been authorised via EU systems and used safely and effectively for many years.

13 Day Zero Issues Centralised Products (CP) NB that extra regulatory burden not imposed on companies, requiring them to apply for and obtain a separate UK MA in addition to the centralised application route via EMA. For existing products that were authorised under the CP, want to avoid a need to re-apply to the UK authorities. Possible solution: may be to allow some form of UK/EU mutual recognition.

14 Day Zero Issues Maximum Residue Levels (MRLs) Important that UK does not put in a place a different system to establish MRLs for new substances. Preferred solution: MRLs that apply in UK are the same as in the EU and remain aligned going forward. Also must identify a way for a UK based company to apply for the establishment of an MRL via the EMA.

15 Day Zero Issues Products authorised under existing EU regulatory framework Where MA was obtained via the various routes to market (e.g. Mutual Recognition Procedure/Decentralised Procedure (MRP/DCP)), a system to allow continued use of these VMPS without additional regulatory burden and cost needed. Possible solutions: for existing products to be granted grandfather rights and for them to be automatically registered with national authorisations in the UK. Where UK is the Reference Member State (RMS) for the procedure- this role may need to be transferred to another MS- questions re resource implications within EU regulatory network

16 Day Zero Issues Common labels between the UK and Ireland Clarity on plans with the Republic of Ireland needed as many veterinary medicines have common labels for both UK & Irish markets Some products may not be viable for Irish market if joint labelling not allowed to continue For Animal Health and Welfare, NB that Ireland does not lose access to products

17 Day Zero Issues Qualified Persons for Pharmacovigilance (QPPV) Post Brexit, plans needed for EU QPPVs who are required to reside in the EU; if the QPPV resides in the UK- problem? Similarly, if the EU QPPV is based in Europe- could pose problems for the UK products for which they are named. Consider Detailed Description of the Pharmacovigilance System (DDPS) and where it is located?- a transitional phase is needed if a UK specific DDPS is going to be required. Any measures that could avoid the need for both a UK and EU DDPS would help prevent additional unnecessary regulatory burden.

18 Day Zero Issues Potential loss of access to EU IT infrastructure projects For example submission portals (Common E Submission Platform), pharmacovigilance database (EudraVigilance), EudraGMDP (database relating to Good Manufacturing /Distribution Practice)-all provide efficiencies and benefit to both regulators and industry. UK may no longer have access post Brexit. Development of UK specific systems is possible but costly. Possible solution: Joint agreement allowing the UK to participate in the infrastructure supporting EU network?

19 Day Zero Issues At the point of EU exit, possible that the VMD may be in the process of carrying out assessments on applications within existing EU regulatory framework. Transition plans needed to to ensure such applications can reach completion. Preferred solution: Allow for transition plans that ensure that ongoing applications can reach completion Prior to day 0 clear timelines established which indicate when the last European application involving UK (centralised, decentralised, mutual recognition) can be submitted and be taken through to completion with UK still involved in the final decision.

20 Moving forward: opportunities Develop world-leading innovative regulatory system VMD currently recognised by many as leading regulatory agency Improve IP/data protection to encourage new product development Internationally recognised scientific research UK specific diseases or species - special routes to authorisation? System developed to encourage that UK becomes first choice market for new product launch

21 Moving forward: threats. Products are not developed just for UK market e.g. vaccines, immunotherapy Risk to both existing & new products UK loses access to essential veterinary products Uncertainty = risk to UK science base Animal health & welfare compromised Industry loses benefits of new EU Veterinary Medicines legislation

22 What is NOAH doing? Brexit Conference planned- One Great George Street, London, 01/11/2017 Tickets via Event Brite co.uk/e/brexit-whatsthe-future-for-animalhealth-tickets

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