copy the linklink copied!4. Sectoral case studies

Main rationale for international regulatory co-operation in the sector

The financial services sector is of major importance for the UK’s economy. In 2018, it accounted for nearly 7% of the country’s GDP and about 3% of all jobs (Rhodes, 2019[1]). Moreover, the United Kingdom is a leading exporter of financial services across the world. This sector of activity accounted for 23% of all UK service exports and 9% of all service imports in 2017, and has consistently yielded trade surpluses over the years (Rhodes, 2019[1]). In addition, London is an international financial hub attracting substantial amounts of FinTech investment (more than USD 16bn in the first half of 2018, or about 28% of the world’s total) (TheCityUK, 2018[2]).

Strong IRC is therefore essential if the United Kingdom is to retain its leadership and continue to promote innovative regulatory approaches. IRC is also crucial to ensure business continuity in the context of Brexit. The EU is the UK’s largest financial services export market (43% of exports and 34% of imports in 2017), and UK banks have subsidiaries in many EU member states. Moreover, the development of the EU’s single market for financial services resulted in the expansion of EU legislation applying to financial services, and post-crisis reforms led to “a certain degree of centralisation and transfer of responsibility from the national to EU level in many aspects of financial services regulation and supervision”.2 Key areas of regulation, which are set at the EU level, include the prudential regulation of banks, investment firms and insurers, the regulation of financial markets, and conduct regulation of key financial products such as insurance and retail investment products (HM Treasury, 2019[3]).

HM Treasury recently acknowledged the importance of IRC in its “Financial Services Future Regulatory Framework Review”. According to the Review, “… an optimally designed regulatory framework should facilitate co-operation and the development of common standards across international regulatory bodies and jurisdictions, and support the ability of UK financial services to compete in international markets, as well as ensuring that the United Kingdom is open and attractive to new and existing trading partners” (HM Treasury, 2019[3]).

UK bodies involved

At the domestic level, responsibility for financial regulation in the United Kingdom is shared between the following bodies:3

• HM Treasury: focuses on the overall institutional structure of financial regulation (including negotiation of European legislation when the UK was a member of the EU).

• Bank of England (BoE, including the Financial Policy Committee, or FPC): responsible for macroprudential regulation and overall resilience of the financial sector.

• Prudential Regulation Authority (PRA): the UK's prudential regulator for deposit takers, insurers and designated investment firms.

• Financial Conduct Authority (FCA): the conduct supervisor of all UK regulated firms, prudential supervisor for those firms not falling under PRA’s prudential supervision, including asset managers, mortgage and insurance brokers. The FCA is also responsible for the regulation of UK’s primary and secondary markets. It works closely with HMT, the BoE, the PRA and the FPC.

• Payment Systems Regulator (PSR): a subsidiary of the FCA that regulates the payment systems industry (including through standard setting and actions to safeguard competition).

UK representation in international fora on financial regulation is spread across several authorities including HM Treasury, the BoE, the FCA and the PRA. There is also involvement from the Foreign and Commonwealth Office (FCO) and the Department for International Trade (DIT) (chiefly on economic and financial dialogues and discussions about financial services in trade agreements). An MoU exists for consultation and co-operation amongst the authorities representing the country in the different fora.4 It allocates international representation roles to the various UK institutions, acknowledging that the list of interested parties is not comprehensive and that, in some international organisations, there is “scope for flexibility in sub-committee or working group participation”. This MoU aims at ensuring consistency in the UK’s position and line in discussions with international partners. It establishes an International Coordination Committee that is responsible for ensuring that the UK authorities act in accordance with its principles. The MoU, which is an example of good practice (as it ensures transparency and considers implementation aspects) is to be reviewed “at least annually”.

Bilateral co-operation initiatives

Bilateral co-operation activities between the United Kingdom and other countries on financial regulation take a variety of forms, which differ in terms of depth and scope. Previous agreements with major economic partners have taken the form of joint statements. Most of them focus primarily on information exchange but the most recent ones have targeted the compatibility of the countries’ respective rules. Co-operation may also take the form of dialogue fora or technical assistance projects (typically with smaller partners).

Regulatory co-operation with major economic partners tends to unfold within the framework of larger co-operation initiatives that go beyond regulatory matters (e.g. macroeconomic policies, infrastructure development, trade agreements etc.). For example, the Economic and Financial Dialogues (EFDs) with China,5 India6 and Brazil,7 take place on an annual or biennial basis and are led by the Chancellor of the Exchequer (the FCA and the Bank of England are also involved), and aim to strengthen communication and increase co-operation between the United Kingdom and these markets.

The U.S.-UK Financial Regulatory Working Group was created in April 2018 to formalise the two countries’ bilateral regulatory co-operation engagement, notably in the context of “the transition in the UK’s regulatory relationship with the EU due to Brexit”.8 A joint statement announced its creation in April 2018 as a forum “to exchange views on the regulatory relationship between the United States and the UK”. It gathers officials and senior staff from the U.S. Department of the Treasury and HM Treasury, and from the U.S. and UK independent regulatory agencies. The statement suggests a higher level of ambition compared to co-operation with the abovementioned emerging economies in that it aims to “improve transparency, reduce uncertainty, identify potential cross-border implementation issues, work towards avoiding regulatory arbitrage and towards compatibility, as appropriate, of each other’s national laws and regulations”.9 The joint statement that followed the Working Group’s second meeting in May 2019 highlighted discussions about “financial regulatory reforms and future priorities, including possible areas for deeper regulatory co-operation to facilitate further safe and efficient financial services activity”.

In addition, the UK has entered a series of broader dialogue fora with countries including Japan, Korea, Singapore, Hong-Kong and Switzerland. These may be formalised through an MoU (but not necessarily) and keep a flexible agenda in order to focus on areas of mutual interest. They usually focus strongly on information exchange.

FCA has concluded MoUs with many of its regulatory counterparts to facilitate the exchange of information and support investigative assistance related to the supervision and oversight of regulated entities in the United Kingdom and the partner jurisdiction. Examples include MoUs signed between the FCA and the Hong Kong Securities and Futures Commission (SFC),10 the United States Commodity Futures Trading Commission (CFTC),11 and the Reserve Bank of India.12

Given the growing importance of regulatory issues relating to the FinTech sector, since 2016 the United Kingdom has set up a number of “FinTech bridges”, which are bilateral co-operation agreements “outlining collaboration between two governments, co-operation between regulatory bodies and connectivity between two markets and ecosystems”. Fintech bridges are co-developed by DIT, HMT and FCA and serve to facilitate compliance and enhance market access for FinTech companies and promote trade and investment with priority international markets for UK firms. Each bridge is underpinned by a co-operation agreement signed by the FCA. Some enable a referral mechanism for already licensed firms that meet specific criteria seeking authorisation in corresponding markets; others enable a referral mechanism for already licensed firms that meet specific criteria seeking authorisation in corresponding markets. Countries with which the United Kingdom has concluded this kind of agreements are listed in Table ‎4.1.13

Engagement in regional or international bodies / initiatives

With increasingly global and interdependent financial markets, rules to govern them are increasingly being set at the regional and multilateral level. The bulk of EU legislation in this area has been transposed into domestic UK law. In the same vein, the country has adopted all main international instruments.

Whilst the United Kingdom was still a member of the EU, the UK Treasury and FCO represented the United Kingdom at the Council of the European Union’s meetings on financial services legislation. Treasury also engaged with the European Commission, which is responsible for initiating new legislative proposals. The UK regulators engaged with European supervisory authorities, such as the European Securities and Markets Authority (ESMA), the European Banking Authority (which has recently relocated from London to Paris ahead of the withdrawal from the EU) and the European Insurance and Occupational Pensions Authority, and were able to vote on proposed Binding Technical Standards.14

The United Kingdom has played an active role over the years in the activities of the Financial Stability Board (FSB), an international body that promotes the reform of international financial regulation and supervision15 and is responsible for monitoring implementation of relevant standards (e.g. for solvency and liquidity). Bank of England Governor Mark Carney served as Chair of the FSB between 2011 and 2018. Representatives from Treasury, FCA and the Bank of England attend FSB’s plenary meetings and are members of its standing committees. There is regular co-operation across the different UK bodies involved in the different committees to ensure consistency.

The FCA and Bank of England also engage extensively with the international organisations, including the Basel Committee on Banking Supervision, the International Organization of Securities Commissions (IOSCO), and the International Association of Insurance Supervisors. The United Kingdom (via the FCA) is among the signatories of IOSCO’s Multilateral Memorandum of Understanding (MMoU) Concerning Consultation and Cooperation and the Exchange of Information,16 which emerged as a response from regulators to the increasing international activity in the securities and derivatives markets 17 and provides a useful framework exchanging confidential information for the purpose of regulatory enforcement, thus facilitating cross-border co-operation. The FCA has been actively involved in developing and enhancing the MMoU over time, and regularly uses the MMoU as the basis for co-operating with its international counterparts. It has also been actively involved in IOSCO’s enforcement and co-operation committee as well as in the development of the new, enhanced MMoU (the FCA having been its first EU signatory).

Moreover, the FCA works extensively with the Financial Action Task Force (FATF), an inter-governmental body promoting national legislative and regulatory reforms pertaining to money laundering, terrorist financing and other related threats to the integrity of the international financial system.18 According to FCA officials, their efforts in this context focus increasingly on multilateral initiatives. A promising initiative that is currently being explored in this regard has to do with enhanced co-operation between law enforcement entities and banks (as well as within each of those groups of actors) on money laundering and terrorist financing. Successful co-operation examples of this kind already exist in certain national jurisdictions such as Australia and Hong Kong. Table ‎4.2 outlines the UK authorities represented in selected relevant international organisations, as per the MoU.

The United Kingdom is also active launching new multilateral initiatives. The Global Financial Innovation Network (GFIN) was launched in January 2019 by an international group of financial regulators and related organisations, including the FCA.19 It builds on the FCA’s 2018 proposal to create a “global” regulatory sandbox.20 Its main functions are:

• To act as a network of regulators to collaborate and share experience of innovation in respective markets, including emerging technologies and business models, and to provide accessible regulatory contact information for firms.

• To provide a forum for joint RegTech work and collaborative knowledge sharing/lessons learned.

• To provide firms with an environment in which to trial cross-border solutions.

Regulators involved launched a pilot phase of cross-border testing (for firms) in January 2019, receiving over 40 applications from firms based around the world. The pilot, which is still ongoing at the time of writing, will inform the future direction GFIN takes with regards to future cross-border testing activity.

Outstanding challenges

Among the four long-term challenges identified by the Chancellor of the Exchequer with regard to the UK’s financial services sector, two refer explicitly to IRC. The first one has to do with operating outside the EU. Key areas of UK financial regulation are currently set at EU level. Regulatory arrangements will therefore need to be adapted “to reflect the UK’s new position outside of the EU and its single market for financial services”. The second challenge lies with the opening of the UK’s regulatory framework to new markets beyond Europe, and “support the development of new trading relationships as well as facilitating co-operation on international standards and supervision”.21

In terms of thematic areas, IRC’s relevance is particularly noteworthy in the context of a rapid development of cryptocurrency exchange services and virtual assets and its implications for the application of legislation on anti-money laundering/combating the financing of terrorism. IRC can be instrumental in helping develop regulatory approaches that effectively address related challenges (often involving transnational actors).22 International peer review mechanisms in this area have also been highlighted as potential means for sharing best practices and building the necessary capacity at regulatory and enforcement bodies. The UK Parliament reflected upon the role of IRC in this area as part of its 2018 “Crypto-assets” report by noting that “given the UK has yet to introduce any crypto-asset regulation, it is in a position to learn from those experience of countries that have done so”.23 In their joint response to the inquiry report, the UK government and FCA envisage that “the UK will be a thought leader in shaping future regulatory approaches”.24

Main rationale for international regulatory co-operation in the sector

As stated in the Strategic Framework for International Engagement to 2025 published by the ONR in May 2019 (Box ‎4.1), hereinafter “the Framework” (ONR, 2019[5]),26 “the global nature of the nuclear industry and the potential trans-boundary impact of any severe nuclear accident” mean that the United Kingdom will need to step up its engagement in IRC in the years to come. In the same vein, the Framework refers to IRC as a means to “influence standard-setting globally and ensure their output takes account of UK regulatory practice and meets the UK needs”. Historically, the United Kingdom has been co-operating significantly on nuclear safety issues in the EU and beyond the EU, both bilaterally and multilaterally.

The UK withdrawal from Euratom has implications, in the absence of a formal agreement with Euratom, for the security of supply of nuclear materials and the ability to promote nuclear medicine research. IRC appears to be essential in order to avoid disruptions in this respect.

UK bodies involved

Key UK public bodies involved in nuclear energy-related IRC are the ONR and the FCO, which co-ordinate closely with each other. The former typically participates in committee meetings of relevant standard-setting organisations, whereas the latter operates through the country’s permanent missions. The Secretary of State for the Department for Business, Energy and Industrial Strategy (BEIS), in turn, has overall responsibility for the UK’s civil nuclear regulatory framework and policies, including preparations for the UK’s withdrawal from the EU.27 In this sense, it is worth noting that in its Framework ONR foresees to “develop and agree a streamlined framework and formal process with the Department of Business, Energy and Industrial Strategy (BEIS)”. Other bodies involved in multilateral standard-setting processes are the Department for Transport (DfT) and the National Information Infrastructure (NII).28

Bilateral co-operation initiatives

UK authorities co-operate with a range of regulatory bodies in EU as well as non-EU countries. These include mature nuclear powers as well as aspirant nuclear nations. According to the Framework, the ONR is “committed to working with aspirant nuclear nations to support the development of high standards of safety and security” and sees itself as having a role to play “in raising the bar internationally for public protection” and “supporting Government’s interactions with like-minded pro-nuclear countries and those where the UK seeks to influence non-proliferation efforts”.

Formal agreements typically take the form of either Nuclear Cooperation Agreements (NCAs) or Information Exchange Arrangements (IEAs) (Table ‎4.3).

NCAs are legally binding, bilateral agreements negotiated between two States (or international bodies) covering co-operation in the civil nuclear sector. According to BEIS, “every NCA is different and is negotiated on a case-by-case basis”. While they allow states to formally recognise their willingness to co-operate with each other, they do not normally commit either side to undertake any specific activity (BEIS, 2018[6]).

IEAs, in turn, are bilateral agreements with other nuclear regulators to “share information, experience and good practice where it is believed to be mutually beneficial and in the UK’s national interests”. ONR points out that “it does not have IEAs with every country with which it exchanges information, as mutual co-operation is often achieved informally between signatories of the various international conventions”. Like NCAs, each IEA differs, although they frequently cover information concerning the regulation of siting, construction, commissioning, operation, transport of radioactive material, radioactive waste management and decommissioning of civil nuclear installations, preparedness and management of nuclear and radiological emergencies.29 Consulted ONR officials highlighted the existence of regular exchanges of information on inspections, enforcement and “nuclear innovation” with partner countries. In this respect, they singled out co-operation with Japanese authorities to improve inspection practices. Information exchanges were also identified as a valuable source of evidence in the context of the upcoming post implementation review of the Energy Act, which is to take place in 2021.

In addition to NCAs and IEAs, bilateral regulatory co-operation also takes place as part of international co-operation initiatives. In the context of the International Atomic Energy Agency’s Integrated Regulatory Review Service (IRRS), the ONR provides experts for review missions in other countries. In the same vein, the United Kingdom hosts and contributes experts to missions by the International Physical Protection Advisory Service (IPPAS), which cover nuclear security practices.

Engagement in regional or international bodies / initiatives

ONR co-operates extensively with international organisations to “influence globally, learn from relevant international good practice and maintain alignment with international obligations, standards and conventions”. IRC allows the United Kingdom to keep abreast with regulatory developments and ensure that multilateral approaches under development take into account the country’s needs and specificities. Worldwide regulatory co-operation is indeed all the more important given the potential consequences of a nuclear accident and the associated need to uphold the highest safety and security standards. To this end, UK authorities notably participate in the work of the International Atomic Energy Agency (IAEA), the European Nuclear Security Regulators Association, the Western European Nuclear Regulators Association (WENRA), the Nuclear Energy Agency (NEA), the World Institute for Nuclear Security and the International Regulators Conference on Nuclear Security (Box ‎4.2).

The United Kingdom became part of Euratom in 1973, when it joined the European Economic Community. Euratom encompasses a safeguards regime applying to all nuclear facilities and movements of nuclear products and materials in the United Kingdom. According to a spokesperson for the UK Nuclear Industry Association (NIA), Euratom safeguards preventing nuclear material from being diverted from civil nuclear power for other means and thus enable the United Kingdom to abide by its non-proliferation requirements under international law. As a member of Euratom, the United Kingdom had co-operation agreements with eight other countries, including Australia, Kazakhstan and Canada, which between them account for more than 70% of uranium production worldwide (NS Energy, 2018[7]). Euratom also regulates the supply of the isotopes used in nuclear medicine.

To avoid damaging disruptions in any of these areas arising from the UK’s withdrawal from the EU and Euratom, the UK Government has proposed a new civil nuclear relationship based on a wide ranging NCA with Euratom (ONR, 2019[4]). This NCA is expected to include a co-operation mechanism between ONR, as the UK’s Safeguards regulator and State System of Accountancy and Control of Nuclear Materials (SSAC), and Euratom. ONR is also a member of the European Safeguards Research and Development Association (ESARDA) and, intends, according to the Framework, to remain so and “enhance its role in ESARDA’s work as the UK leaves Euratom” (ONR, 2019[4]).

Outstanding challenges

Looking ahead, a number of challenges deserve particular attention. These are acknowledged in the Framework.

• To avoid any disruptions to the UK’s civil nuclear activities, it will be important to remain committed to nuclear safety and security across Europe by implementing relevant provisions under Euratom Directives transposed into UK law and pursuing its international engagement to ensure the existence of a suitable post-Brexit safeguards regimes.

• Efforts will need to be deployed to ensure a consistent approach to regulating emerging technological innovation in the field of nuclear energy. This could build upon existing information and best practice exchanges with partner countries (including at the SMR Regulators’ Forum) but may also warrant innovative co-operation modalities that help develop a suitable regulatory environment.

Main rationale for international regulatory co-operation in the sector

According to a representative of the Medicines and Healthcare Products Regulatory Agency (MHRA), “working in an increasingly global environment, the sharing of intelligence between medicines regulators is the cornerstone of protecting the health system worldwide”.30 In addition, strong regulatory co-operation is particularly important for frictionless cross-border trade in pharmaceuticals, as supply chains for medicines are deeply integrated and often involve production processes that span a number of countries.

Generally speaking, the United Kingdom is heavily dependent on the EU market for medicines and healthcare products. UK exports of pharmaceutical products were worth an estimated GBP 23.5 billion (about EUR 21.2 billion) in 2018, 46% of which to EU countries; whereas UK imports of pharmaceutical products were worth GBP 23.4 billion in 2017, 76% of which from EU countries.31

The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries, the European Commission and the European Medicines Agency (EMA). EMA works with national bodies, including from the United Kingdom, in the regulation and licensing of medicines and medical devices and monitoring of their safety. Based on the single EU regulatory system for pharmaceuticals, confidential information is exchanged between the EU member states and results of inspections carried out by any of the EU member states are automatically recognised by all. According to EMA, this regulatory system offers the following benefits:32

• Enables member states to pool resources and co-ordinate work to regulate medicines efficiently and effective

• Creates certainty for patients, healthcare professionals, industry and governments by ensuring consistent standards and use of best available expertise

• Reduces the administrative burden through the centralised authorisation procedure, helping medicines to reach patients faster

• Accelerates the exchange of information on important issues, such as the safety of medicines.

UK bodies involved

As explained in a UK Parliament research briefing (House of Commons, 2019[8]):

Bilateral co-operation initiatives

The EU regulatory system for medicines allows EU member states to sign individual bilateral arrangements33 with third countries. In recent years, the United Kingdom has intensified its bilateral regulatory engagement beyond the EU, including with key actors such as China, the US and Canada.

In February 2019, the United Kingdom and the United States signed a MRA on Conformity Assessment, including for pharmaceuticals, that will maintain all relevant aspects of the current EU-US MRA once it ceases to apply to the United Kingdom (so “UK exporters can continue to ensure goods are compliant with technical regulations before they depart the UK”). Similar agreements have also been signed with New Zealand and Australia.34 UK authorities have also engaged in joint inspections for good clinical practice (GCP) with their Canadian and US counterparts (Health Canada and USFDA).

In addition, the country has concluded MoUs with several countries. These generally cover the exchange of information (e.g. on clinical trials, compliance, etc.) under a confidentiality agreement. MoUs are not legally binding but help to build trust relationships that may lead to the conclusion of an MRA. In 2018, MHRA signed an MoU with the China Food and Drug Administration (CFDA) that expands on the previous one signed in 2014 (focused on the exchange of safety information on medicines and medical devices). The new agreement is of particular interest in that it “pledges new areas of co-operation such as an exchange of learning from the accelerated access review (AAR) and how to effectively regulate the trading of medicines online”.35

Early 2019 MHRA signed an MoU with its Russian counterpart. In addition to the exchange of information on medicines regulations and safety issues, this MoU foresees co-operation on Good Manufacturing Practice (GMP) inspections as well as on enforcement activities.36

MHRA’s bilateral regulatory co-operation agreements are presented in Table ‎4.4.

Engagement in regional or international bodies / initiatives

Whilst a member of the EU, the United Kingdom, via MHRA, was part of the European Medicines Agency (EMA),37 which encompasses over fifty national regulatory authorities for human and veterinary medicines in the European Economic Area. The EMA, whose offices moved from London to Amsterdam ahead of the withdrawal from the EU (pharmaceuticals regulation should be done in a member state), is at the network’s core. UK experts participated in EMA’s scientific committees, working parties and other groups, including multinational assessment teams for marketing authorisation applications and post-authorisation applications to extend existing marketing authorisations.38 In the same vein, the United Kingdom was part of the EU Pharmacovigilance Risk Assessment Committee and had access to the EudraVigilance system for managing and analysing information on suspected adverse reactions to medicines authorised in the EEA.39 Moreover, MHRA was part of the National Competent Authority Report Exchange, which serves to share safety information on medical devices across the EU.

As part of the EU delegation, the UK participated in the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This organisation, which brings together the regulatory bodies of the EU, the US and Japan as well as representatives from the pharmaceutical industry, works to harmonise medicines registration globally. Its Council issues guidelines on requirements for medicines registration that, while not legally binding, are extensively applied in member jurisdictions (as ICH regulators commit to implementing them40). In addition to being part of the EU delegation, the UK played a role in several ICH expert working groups.

Since 1999, MHRA is also a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which is a network of Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It comprises 52 participating authorities from across the world (Europe, Africa, America, Asia and Australasia). “PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence”.41

As an OECD member country, the United Kingdom participates, via MHRA, in the OECD’s Working Group on Good Laboratory Practice (GLP), which also covers other product categories such as chemicals. The Group notably seeks to ensure that test data have been generated in accordance with the organisation’s GLP principles. To do so, it aims at facilitating information exchanges among monitoring authorities to avoid duplication, allow an efficient allocation of resources and ensure adequate compliance monitoring (harmonising testing procedures for the Mutual Acceptance of Data, or MAD).42

Moreover, the United Kingdom is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), which aims at addressing “current and emerging human medicine regulatory and safety challenges globally”.43 UK authorities also engage in co-operation on bioequivalence studies as part of the work of the World Health Organisation to issue international guidance in this area.44

Outstanding challenges

Continued alignment with European regulations and associated networks appears to be critical for the supply of safe and effective medicines and medical devices to the United Kingdom, as well as for appropriate monitoring and market surveillance and continuity of business in the country’s pharmaceutical sector. In March 2018, the UK’s Health and Social Care Select Committee did indeed call on the government to secure “the closest possible regulatory alignment with the EU on medicines and medical devices regulation”. Other potential withdrawal-related risks include delays in the detection and management for pharmacovigilance, loss of the UK’s influence in the ICH, and delays in accessing specific types of medicines (e.g. for rare diseases).45

The UK Government has in turn repeatedly stated its willingness to pursue a close relationship with EMA as well as the EU regulatory network on medicines and medical device regulation. While continued membership does not seem to be an option for the time being (no provisions exist for third countries to become members or observers at the EMA), existing agreements between the EMA and third countries such as Switzerland, the US and Canada could be models worth considering.

Main rationale for international regulatory co-operation in the sector

With the development of the EU single market, the EU acquis and UK law in the area of consumer protection, including consumer product safety, became increasingly interwoven (House of Lords, 2017[9]). The UK’s current product safety and metrology regime is based mostly on EU legislation, so as to enable the free trade of goods which meet EU-wide product safety and metrology specifications and mutual recognition for accredited bodies.47

A 2017 report by the House of Lords highlights the benefits from the EU acquis in this area. It provides a harmonised framework that strengthens the legal protection of citizens. It facilitates information sharing so cross-border problems can be “tackled at both ends”. It facilitates market surveillance and the enforcement of trading standards through investment in enabling infrastructure – the Safety Gate rapid alert system being a case in point.

Following the UK withdrawal from the EU, the results of conformity assessment carried out by UK conformity assessment bodies are no longer recognised in the EU. As a result, products due to be placed on the EU market need to be assessed by an EU recognised conformity assessment body.48 Given, the importance of the EU as an export market as well as of the consumer products category (it accounts for about one-quarter of trade in goods worldwide) (UNCTAD, 2019[10]), the United Kingdom needs to ensure that its domestic legal framework in this area remains interoperable with the EU and endowed with suitable enforcement mechanisms. This perspective raises the critical importance that IRC will take in the future.

The importance of IRC has been acknowledged in OPSS’ 2018-2020 Strategy for strengthening national capacity for product safety. The Strategy states the UK’s willingness “to remain at the leading edge of regulatory innovation through participation and leadership of international networks as well as working with the EU, OECD and other partners to address pan-European and global safety risks”. The Strategy highlights the role of European and international standards in building consumer confidence and providing a clear framework against which businesses can achieve and demonstrate compliance. It also acknowledges that “common standards greatly reduce the cost and complexity for industry and consumers, enable business to operate easily across borders and simplify market access”.

IRC is also becoming increasingly important in the areas of enforcement and market surveillance given the emergence and increasing market power of new categories of actors that span across jurisdictions (e.g. online platforms) as well as the need to respond in a co-ordinated fashion to the questions raised by rapid technological change and product innovation.

UK bodies involved

The Office for Product Safety and Standards (OPSS),49 which was created in 2018 and is part of BEIS, oversees the regulatory system for product safety and standards in the UK. Its remit covers general (non-food) consumer product safety such as white goods, electrical goods, toys, clothes and cosmetics, except for areas where national capability and regulators already exist (e.g. vehicles, medicines and medical devices, workplace equipment).50 OPSS’s website highlights the Office’s efforts in support of operational best practice and co-ordination of local regulation of product safety and metrology. It also highlights, as part of its core functions, how OPSS works to share its expertise in this area domestically as well as internationally.

Product safety under the EU

EU rules on product safety are defined in the New Legislative Framework as well as in the General Product Safety Directive. Under the Directive, a product is safe if it meets all essential safety requirements under European or national law. If there are no regulations or European standards, the product's compliance is determined according to other reference documents such as national standards, Commission recommendations, codes of practice, etc.51

Regulatory co-operation in the EU/EEA area is particularly strong in the area of market surveillance. The Safety Gate rapid alert system52 (also known as RAPEX) and its associated database is a cornerstone in this regard. It enables quick exchange of information between countries and with the European Commission about dangerous non-food products posing a risk to the health and safety of consumers.53 Beyond the EU, the Information and Communication System on Market Surveillance (ICSMS) provides an IT platform for communication between EU and EFTA market surveillance bodies on non-compliant products. It aims to avoid the duplication of work (“as it records both compliant and non-compliant products, scarce resources can be optimised by not undertaking testing/sampling on products previously found compliant by other surveillance authorities”).54 It also speeds up the removal of unsafe products from the market.55

Under this framework, OPSS aims at ensuring that all relevant international standards are taken into account in UK legislation as much as possible. OPSS also has responsibility for specific UK domestic legislation e.g. furniture and fire safety. While the United Kingdom was a member of the EU, OPSS was also the UK’s national contact point for the EU market surveillance system, under which the Commission published a weekly summary of alerts reported to it by the relevant national authorities (e.g. local authorities and national trading standards bodies). This included information on the dangerous products found, associated risks and any measures taken in the notifying country to prevent or restrict their marketing or use (House of Lords, 2017, p. 14[9]).

The UK authorities have acknowledged that, without action (e.g. to convert EU-derived product safety and metrology legislation into UK law), the withdrawal from the EU threatens the country’s current product safety regime. This has implications for consumer protection as well as business continuity.56 The UK government has expressed its willingness to retain access to both Safety Gate and ICSMS following the withdrawal. OPSS has also taken steps to develop its own product safety database.

IRC beyond the EU

While the United Kingdom was a member of the EU, its regulatory co-operation at the bilateral level (i.e. with jurisdictions beyond Europe) in the product safety field was conditioned by its participation in the EU single market: once a product was lawfully placed on the market in one member state, it could be marketed in any member state without barriers – subject to some limited exceptions (Webb and Wright, 2018[11]). This de facto meant that any bilateral agreement had larger implications than for the United Kingdom only.

One referent of the co-operation between the EU and non-EU partners can be found in the EEA model. In order to allow access to the EU single market, this model requires that the parties replace their national laws on product safety with the harmonised European laws on product requirements. Similarly, enhanced mutual recognition agreements (MRAs), which are based on an alignment with EU rules, currently exist between the EU and Israel, Switzerland and Turkey. The EU also has MRAs with Australia, Israel, New Zealand and the US, as well as with Canada, Japan and South Korea (within the context of their respective FTAs). These tend however to be narrower in scope (e.g. limited to conformity testing in the case of the MRA with the US) (Webb and Wright, 2018[11]).

After leaving the European Union, the United Kingdom may have to engage more extensively in greater IRC, both at the bilateral and the multilateral levels, to compensate for the possible loss in trade and the safety risks raised. The country has recently concluded bilateral MRAs on conformity assessment with the United States, Australia and New Zealand to ensure continuity of trade once the current agreements that those countries have with the EU cease to apply to the United Kingdom.

The OPSS also maintains a Technical Assistance Programme, through its Regulatory Delivery International team, which provides technical advice to developing countries in order to promote the reform or design of regulations, laws and strategies. The team works with other government departments with an international focus, including DIT, DFID and through the FCO Prosperity Fund.57 Recent examples of these projects have included working with the Government of Indonesia to put into place systems for improved central oversight and co-ordination of regulatory reform.

OPSS sponsors the British Standards Institution (BSI), which is a member of the International Organization for Standardization (ISO) as well as the International Electrotechnical Commission (IEC).58 In this context, OPSS is involved in committee meetings for standard development but does not have a primary role. Its work focuses, according to consulted officials, on making the international standard-setting process more inclusive, for example by encouraging BSI to take into account the needs of those ultimately affected by the standards, including in the civil society. In addition, the United Kingdom Accreditation Service (UKAS) is a member of the International Accreditation Forum (IAF), the world association of Conformity Assessment Accreditation Bodies,59 and a signatory of the Mutual Recognition Arrangement under the International Laboratory Accreditation Cooperation (ILAC).60

Outstanding challenges

The modalities of agreement between the United Kingdom and the EU remain uncertain, and the United Kingdom may no longer be able to participate in either the EU’s Safety Gate rapid alert system or ICSMS, which are critical for effective and efficient market surveillance. As the effectiveness of market surveillance activity relies on intelligence, any reduction in available sources of information will have an impact on how market surveillance is targeted. The potential resource implications of such a scenario need to be considered alongside the ongoing reduction in trading standards services, which, according to the Chartered Trading Standards Institute (CTSI) of the UK, “severely limits the UK’s ability to meet the government’s aim for robust market surveillance in the post-Brexit market for goods” (Ctsi, 2018[12]).

CTSI also points to the implications of the UK’s withdrawal from EU legislation networks; e.g. risks of losing out in networking and events such as the Product Safety Week and at Consumer Safety Network meetings. This may in turn result in a loss of expertise and knowledge and could lead to an inconsistent application of relevant EU legislation. In the same vein, the withdrawal from the EU may lead to a gradual deviation in the long term between UK product-related regulations and the EU legal framework in this area.61

With the multiplication of bilateral trade and sector agreements with key partners beyond the EU, the United Kingdom may find itself in a difficult situation of having to balance preserving access to the EU single market and accommodating other jurisdictions’ regulations. A general approach may be difficult to maintain in this context, which may be easier to manage through a sector-by-sector policy depending on market shares (i.e. UK’s overall dependence on EU vs. other markets).

Strong IRC, including on enforcement, will also be important for the UK to address emerging challenges, such as the expansion of e-commerce (including cross-border) and online platforms and the increasingly fast pace of technological change and product innovation.