BRX0045
Written evidence from the Optical Confederation, LOCSU and the College of Optometrists
1. The Optical Confederation represents the 13,000 optometrists, 6,000 dispensing opticians and 7,000 optical businesses in the UK who provide high quality and accessible eye care services to the whole population. The Confederation is a coalition of the five optical representative bodies: the Association of British Dispensing Opticians (ABDO); the Association of Contact Lens Manufacturers (ACLM); the Association of Optometrists (AOP); the Federation of Manufacturing Opticians (FMO) and the Federation of Opticians (FODO).
2. The Local Optical Committee Support Unit (LOCSU) provides quality, practical support to local optical committees (LOCs) in England to help them to develop, negotiate and implement local objectives in respect of primary ophthalmic services.
3. The College of Optometrists is the professional body for optometrists. It qualifies the profession and delivers the guidance, development and training to ensure optometrists provide the best possible care. We recognise excellence through the College’s affixes, by building the evidence base for optometry, and by raising awareness of the profession with the public, commissioners, and health care professionals.
4. Together the Optical Confederation, the LOCSU and the College of Optometrists represent eye health professionals and providers (individual practitioners and companies) who operate in both the NHS and the private sector, and also the manufacturers of medical devices (spectacle frames, spectacle lenses, contact lenses and solutions, and ophthalmic equipment).
5. The priorities must be
6. From the point of view of the eye health sector this means that key considerations are that:
7. Eye health services are provided in the UK by regulated professionals, optometrists and dispensing opticians, who largely work in community-based, privately owned businesses, just like GPs, dentists and pharmacists. Similarly eye health services are a mixture of both NHS funded and patient/client-funded services.
8. In practising their professions of assessing and correcting vision and of investigating and treating eye health conditions, optometrists and dispensing opticians routinely prescribe, use or supply various medicines and medical devices to their patients. As a result the UK has one of the most cost-efficient and accessible eye health care systems in Europe.
9. A not insignificant number of optical businesses also manufacture spectacle frames, spectacle lenses and contact lenses and solutions in the UK. These products are sold across Europe (and world-wide) as well as the UK and again any variations in standards would make this more difficult, undermining patient safety and markets.
10. Individual professionals and many optical businesses providing eye health services are regulated by the General Optical Council (GOC). The regulation of the optical professions varies across Europe, with UK standards differing from most other EU member states, apart from the Republic of Ireland and the Netherlands. The impact on the professional optical workforce and therefore the delivery of eye health services is therefore likely to be minimal.
11. However, medicines and medical devices (including spectacle frames, spectacle lenses, contact lenses and solutions, and ophthalmic equipment) used and prescribed to people with eye health and vision conditions are subject to international and EU licensing, standards and regulation.
12. It will be important that UK eye care practitioners can continue to access the medicines and medical devices patients need, with no disruption of supply, variation in standards or regulations or additional costs.
13. It is also important that UK manufacturers face no additional burdens when importing from and exporting to European, or other markets. We therefore want to see continuity and consistency in approaches to standards and regulation of medicines and medical devices.
14. The UK has entered a potentially protracted period of uncertainty. There is a whole raft of regulations which are in a state of flux. We would be very concerned if notified bodies were to interpret any of these in a restrictive or excessive way, and would suggest they should act with restraint until clarity prevails. Without such restraint and care, this is exactly the sort of environment which smaller companies will not be able to manage. It will also increase the resources required by larger companies and the time to market for new innovations. In both cases this runs the risk of fatally harming our growing UK-based businesses and the UK’s future prosperity.
15. We would also be extremely concerned if, as a result of Brexit, additional tariffs were levied on medicines and medical devices imported from Europe into the UK, or from elsewhere in the world, or if tariffs were imposed on UK exports.
16. It will be important to ensure that the legal and regulatory system post-Brexit continues to recognise products that are licensed across the EU and that approaches to licensing and standards remain consistent – indeed that common standards continue to apply across Europe. We would strongly suggest that the regulation of both medicines and medical devices in the UK continues in parallel with, and ideally as full partners with the EU.
17. The MHRA, which has responsibility for the regulation of medicines and medical devices in the UK, has played an important role in negotiating standards across Europe for the benefit of both EU and UK citizens. We believe it is important that the UK continues to be able to fulfil this function and contribute to and influence those discussions and decisions for example through participation in working groups.
18. Although the ISO system is outside EU jurisdiction, the UK works with colleagues across Europe on both ISO and CEN committees to agree and set standards that apply internationally. It would be detrimental for any changes to be made to this. However it should be noted that government funding of this increasingly essential system (via the Department of Trade and Industry) needs to be increased to enable the UK to be properly represented on these committees (funding has been cut every year for many years, so now even an air fare is not covered, let alone hotel and other expenses).
19. In general, CEN, the European Standards body, has adopted the ISO standards unchanged in the ophthalmic optical field, apart from addition of the ZA annexes that are used to relate the standard to the requirements of the Medical Device Directive and hence aid the harmonisation process. With the introduction of the Medical Devices Directive, and consequential repeal of the Medical Device Directive, work is already underway to make some revision of these standards.
20. It is essential to maintaining low UK and NHS health care costs that healthcare providers do not have to navigate new or multiple standards, or increased tariffs on goods manufactured elsewhere in Europe. Reducing access to the European market would reduce choice for patients and likely increase costs.
21. For manufacturers, significant problems would arise if the UK were to adopt a different standards system for medical devices and/or the regulation of medicines. This could limit the ability to sell to European (and world-wide) markets. However, fledgling businesses and SMEs will be at particular risk of stringent regulations so, where the Competent Authority is able to authorise appropriate derogation it should do so.
22. Medicines are licensed for sale across Europe and it will be important that UK eye care practitioners can continue to access the medicines that patients need, with no disruption of supply or being required to comply with different standards set at international and European levels.
23. Beyond Europe, there are opportunities for the UK to develop closer links with other regulatory authorities, such as the FDA in the USA, who, for example, have already adopted a more proportional approach to the introduction of the unique device identifier (UDI) for medical devices by exempting spectacle frames and lenses.
24. Maintaining and continuing to develop collaboration with European and international partners to deliver excellent research is critical to the continued success of the UK academic and professional and manufacturing research communities. UK medical research and development will potentially be affected by Brexit in the following ways:
Harm to UK-international research collaborations / projects already underway, and increased barriers to developing future collaborations and joint research.
25. We need continued UK participation in the Horizon 2020 research and innovation programme to the end of the programme period in 2020.
26. Horizon 2020 provides an established, and key platform for collaborating with key European partners, including six of the UK’s top 10 research partners. Participation in Horizon 2020 allows access to a multi-national pooled financial resource that supports and promotes collaboration. The programme offers globally recognised prestige, enabling access and exposure to networks and contacts that inform further collaborations. It also provides a single regulatory framework for collaboration.
27. Preserving and building on regulatory and standards equivalence with other EU countries will also be very important for facilitating research collaboration and inward UK investment post- Brexit.
Difficulty retaining key staff and recruiting valuable new staff from the international research community.
28. Agreement is urgently needed on the rights to reside and work in the UK post-Brexit for EU nationals that are currently working in the university sector and health professions, and their dependants. Without such clarity there is likely to be a brain-drain from the research sector and manufacturers, who can relocate their R&D functions outside the UK.
Increased barriers to recruiting European and other international students.
29. We need the confirmation that EU students starting a course in 2019–20 will continue to be eligible for home fee status, and be eligible for loans and grants.
Fewer international opportunities for UK nationals to move beyond the UK to work and carry on research, gain experience and develop their careers.
30. We need continued access to Erasmus+ and to the Marie Sklodowska-Curie Actions programmes.
31. Government must use Brexit as an opportunity to invest in international mobility programmes to support international experiences, recognising that Erasmus+ forms a key component in, but only one part of, the wider landscape of two-way investment and mobility for the UK scientific community.