UK: Law And Practice

1. REGULATORY FRAMEWORK

1.1 Legislation and Regulation

The regulation of medicinal products in the UK derives from EU legislation, principally Directive 2001/83/EC (the "Directive") and Regulation (EC) 726/2004 (the "EU Regulation"). The key UK legislation is the Human Medicines Regulations 2012 (SI 2012/1916) (the "Human Medicines Regulations").

The Human Medicines Regulations define a medicinal product as follows:

  • "any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
  • any substance or combination of substances that may be used by or administered to human beings with a view to—
  1. restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
  2. making a medical diagnosis."

Medical devices in the EU are currently regulated by three directives (the "Medical Device Directives"):

  • Council Directive 93/42/EEC on Medical Devices ("MDD");
  • Council Directive 90/385/EEC on Active Implantable Medical Devices ("AIMDD"); and
  • Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices ("IVDMD").

The MMD is applicable to all medical devices, which are defined as "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception;

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means." This includes items such as heart valves, hip replacements, contact lenses, bandages, inhalers and certain software apps.

The AIMDD concerns active medical devices, meaning any medical device that relies on a source of energy or power, other than that directly generated by the human body or gravity, which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, which is intended to remain there after the procedure. This includes devices such as pacemakers, insulin pumps and cochlear implants.

The IVDMD concerns any medical devices that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens. This includes items such as pregnancy tests, blood glucose meters and HIV tests.

Before they could take effect, the Medical Device Directives required transposition into domestic law. In the UK, this was achieved by the Medical Devices Regulations 2002/618. As a result of the diverging interpretations, the EU framework has been applied somewhat inconsistently across the Member States. To address this, in September 2012 the European Commission presented two legislative proposals on medical and in-vitro diagnostic devices. This process culminated in two new directly applicable regulations being adopted 25 May 2017, namely:

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (the "MDR"); and
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (the "IVDR").

The majority of the MDR and IVDR provisions will apply from 26 May 2020 and 26 May 2022, respectively. The information set out below is based on the UK's current legislation, except where stated otherwise.

1.2 Regulatory Bodies

The Medicines and Healthcare products Regulatory Agency ("MHRA") is an executive agency of the Department of Health, acting on behalf of the UK Licensing Authority, with the statutory responsibility to apply and enforce laws governing pharmaceuticals and medical devices in the UK. The MHRA is responsible for managing applications made through the national, mutual recognition or decentralised procedures. However, any applications for marketing authorisation that are submitted through the centralised procedure fall within the remit of the European Medicines Agency ("EMA"). The EMA advises the European Commission in relation to the supervision of medicinal products authorised in the EU, including those authorised through the centralised procedure.

Pricing and reimbursement matters fall primarily within the competence of the Department of Health.

Notified bodies are private organisations that have been designated by an EU Member State to assess whether manufacturers and their medical devices meet the requirements set out in the legislation. Manufacturers can apply to any notified body within the EU for certification. On receipt of an application, the notified body will conduct an assessment which, if successful, will result in the relevant certification being granted to the manufacturer. This certification allows manufacturers to place CE marks on their products, which in turn permits these products to be placed on the EU market.

In the UK, there are five notified bodies, namely:

  • Amtac Certification Services Ltd;
  • BSI Healthcare;
  • Lloyd's Register Quality Assurance Ltd;
  • SGS United Kingdom Ltd; and
  • UL International (UK) Ltd.

The MHRA is responsible for ensuring that medical devices placed on the market and put into service in the UK meet the regulatory requirements. Accordingly, the MHRA does the following:

  • assesses all allegations of non-compliance;
  • monitors the activity of notified bodies that it has designated to assess the compliance of manufacturers;
  • investigates medical devices as a result of adverse incident reports or intelligence that indicates a potential problem; and
  • carries out proactive risk-based projects with other member states in Europe to identify emerging risks.

1.3 Challenging Decisions of Regulatory Bodies

Decisions of the MHRA can be challenged by way of judicial review in the Administrative Court, Queen's Bench Division.

In order to challenge a decision of the MHRA by judicial review, an application must be made promptly, and in any event within three months of the decision to be challenged; this is a strict deadline that cannot be extended by agreement between the parties. In order to bring a claim for judicial review, the applicants must be able to show a sufficient interest in the matter to which the application relates. This will be shown where a decision of the MHRA directly affects the legal rights of enterprises to market or deal in their products for example, refusal to grant marketing authorisation.

The court's permission is required to proceed with a claim for judicial review. The test for permission to be granted is whether there is an arguable case for judicial review that justifies full investigation of the substantive merits. An arguable case is considered to be one with a realistic prospect of success.

The court's function in judicial review is to assess the decision made by the regulator or public authority for legal error. The court cannot remake the decision or make factual determinations. The grounds for judicial review are evolving but can be summarised under four heads:

  • Illegality – did the regulator/public authority misdirect itself in law, exercise a power wrongly, or improperly purport to exercise a power that it does not have?
  • Irrationality – is the decision unreasonable, were irrelevant matters taken into account, were relevant matters not taken into account or was an error of fact made?
  • Procedural unfairness – were relevant statutory procedures or principles of natural justice not properly observed?
  • Legitimate expectation – where the regulator/public authority has set an expectation of how it will behave by its own actions and statements, was this expectation followed?

The judicial review rules and procedures apply equally to challenges concerning other products regulated by a public authority, such as food products.

1.4 Borderlines Between Pharmaceuticals and Other Life Sciences Products

The definition of a medicinal product is set out above. UK law reflects the non-cumulation principle under EU law, whereby products can ordinarily only be regulated as one type of product. The MHRA's Medicines Borderline Section is able to give advice on whether or not a product is likely to be classified as a medicinal product under UK law. Its 'Guidance Note 8' sets out factors that it will consider in determining whether a product should be classified as a medicinal product (rather than, for example, a medical device, cosmetic or food). The MHRA will take account of a range of factors, including:

  • claims;
  • presentation;
  • primary intended purpose;
  • pharmacological, immunological, or metabolic properties;
  • similar products on the market;
  • decisions of other Member States; and
  • relevant ECJ/domestic court precedents.

Where doubt remains, the product in question will be classified as medicinal product.

To distinguish between medical devices and medicinal products, it is important to consider the intended purpose of the product, taking into account the way it is presented, and the method by which the principal intended action is achieved.

The principal intended action of a medical device is typically fulfilled by physical means (including mechanical action, physical barrier, replacement of, or support to, organs or body functions), whereas the principal action of a medicinal product is normally achieved by pharmacological, immunological or metabolic means. A substance administered for diagnostic purposes is also usually considered to be a medicinal product.

Cosmetic products are regulated by the Cosmetic Products Regulation (EC) 1223/2009, which is implemented in the UK through the Cosmetic Products Enforcement Regulations 2013/1478. The definition in the UK Regulations is the same as that in the EU Regulation and focuses on the location of use (the external parts of the body or the teeth) and the purpose – cleaning, perfuming, changing appearance, correcting body odours, protecting, or keeping in good condition. However, such purposes must not be wholly for the purpose of treating or preventing disease.

Foods and foodstuffs are defined in Regulation (EC) 178/2002, which has direct effect in the UK. The classification of foods and foodstuffs will depend on a range of factors, including the scope of any claims made and the actual effect the product has on the body. For example, if a product has a significant pharmacological, immunological or metabolic action (or claims to do so), it is likely to be viewed as a medicinal product.

The MHRA's Borderline Section is able to issue determinations on whether a product falls within the definition of a medicinal product or a medical device. For food and cosmetics borderline cases, advice can be obtained from the Trading Standards Institute.

1.5 Functional Foods and Nutraceuticals

Functional foods and nutraceuticals must comply with general UK food laws. These are principally derived from EU law, and include:

  • Regulation (EC) No 178/2002 (the General Food Law Regulation);
  • Regulation (EU) No 1169/2011 (the Food Information Regulation); and
  • Regulation (EC) No 1924/2006 (the Claims Regulation).

Where necessary, the UK has implemented the EU legislation by way of several legal instruments. The Food Safety Act 1990 (as amended) and the General Food Regulations 2004 make it an offence to falsely describe a food or provide misleading information regarding its nature, substance or quality. The UK Food Information Regulations 2014 put in place additional requirements concerning enforcement and claims.

Food supplements are regulated by the Food Supplements (England) Regulations 2003 as amended (and equivalent regulations in Scotland, Wales and Northern Ireland), which implement the EU Food Supplements Directive 2002/46.

1.6 Intermediate Categories

Since 20 July 2016, Regulation (EU) No. 609/2013 on foods for specific groups (the FSG Regulation) has regulated the labelling and advertising requirements for food intended for certain specific groups, and sets out specific rules for the following four categories of products:

  • infant formula and follow-on formula;
  • processed cereal-based food and baby food;
  • food for special medical purposes; and
  • total diet replacement for weight control.

Food that does not fall within one of these four categories will be subject only to the general food law requirements.

The UK Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 (SI 2016/6881) came into force on 20 July 2016. These implement the minimal requirements of the FSG Regulation and put provisions in place to enable the FSG Regulation to be enforced in the UK.

1.7 Different Categories

There are three categories or "legal classifications" of pharmaceutical products, which determine the level of control over supply. In part, classification rests on how much health professional input is needed to diagnose and treat the conditions for which the medicine might be used. The underlying principle for classifying medicines is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use.

The three legal classifications are as follows:

  • prescription-only medicines (POM) – these have to be prescribed by a doctor or other authorised health professional and have to be dispensed from a pharmacy or from another specifically licensed place;
  • pharmacy (also known as over the counter) (P) – this is an intermediate level of control, and products classified as such can be bought only from pharmacies and under a pharmacist's supervision; and
  • general sales list (GSL) – these may be bought from general retail stores or vending machines.

As discussed above, there are three main types of medical devices:

  • general medical devices;
  • active implantable medical devices; and
  • in vitro diagnostic medical devices (IVDs).

Medical devices are given a classification depending on the level of risk associated with their use. How a medical device is classified will depend on factors including the intended purpose of the device, how long it is intended to be in use and whether or not the device is invasive/surgically invasive, implantable or active, or contains a substance which in its own right is considered to be a medicinal substance.

General medical devices and active implantable devices fall within the following categories:

  • Class I – generally regarded as low risk;
  • Class IIa – generally regarded as medium risk;
  • Class IIb – generally regarded as medium risk; and
  • Class III – generally regarded as high risk.

All active implantable medical devices fall under the highest risk category (Class III).

In vitro diagnostic medical devices are currently categorised into four main groups, namely those which are:

  • considered as general IVD medical devices;
  • within the classifications stated in Annex II List A of the IVDMD;
  • within the classifications stated in Annex II List B of the IVDMD; and
  • for 'self-test' intended to be used by a person at home.

However, the classification of IVDs has been revamped under the IVDR which, as discussed above, will be applicable on 26 May 2022.

To read this Report in full, please click here.

Originally published by Chambers Global Practice Guide 2018.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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