Life Sciences

The UK healthcare system comprises both public and private services.

Since 1999, the UK provision of healthcare has been devolved to the administrations of each of the UK’s four constituent countries. Public healthcare is provided through the National Health Service (NHS) in England and by equivalent bodies in Northern Ireland, Scotland and Wales. The NHS was founded in 1948 with the aim of providing free healthcare at the point of use to the whole population. The Secretary of State for Health is ultimately responsible for the provision of medical services, but discharges this role through the hospitals, clinics and related institutions (some of which may be privately run) contracted by NHS Trusts and Health Authorities and statutory bodies called Clinical Commissioning Groups (CCGs) created under the Health and Social Care Act 2012. The Health and Social Care Act 2012 made fundamental changes to the core structure of the NHS so that, from 1 April 2013, CCGs within NHS England and local area teams share the responsibilities of commissioning healthcare services for patients. CCGs in turn contract to obtain the services of general practitioners (GPs) for use in the community and pharmacy services, and will tender for the supply of certain medicines and clinical services. NHS England is an independent body, at arm’s length to the government. Its main role is to set the priorities and direction of the NHS and to improve health and care outcomes for people in England.

Private healthcare may be provided for those individuals who take out such cover in parallel to the NHS. It is generally used as a complement to NHS services, in particular with respect to non-emergency services or elective procedures.

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Publicly funded healthcare accounts for approximately 88 per cent of total healthcare expenditure in the UK, with the remaining 12 per cent of UK healthcare expenditure funded privately.

With the exception of some charges (including low-cost fees for prescriptions, optical services and dental services for non-exempt patients) the UK public health system offers inpatient and outpatient services that are free at the point of use for all UK residents.

Public healthcare expenditure in Northern Ireland, Scotland and Wales is decided by their respective devolved governments, while NHS expenditure in England is determined by the UK government. Planned NHS expenditure in England for 2018/19 is £126.4 billion, increasing to £127.2 billion for 2019/20. This expenditure (and its equivalents in the devolved jurisdictions) is funded by:

• general taxation (80.9 per cent);
• national insurance contributions, which are payments made by workers and employers towards the cost of certain state benefits (17.9 per cent); and
• user charges (1.2 per cent).

The private healthcare sector in the UK is funded largely by private insurance. It operates its own clinics and hospitals, and may sometimes subcontract its services to the NHS. Certain practitioners in specialist areas work in the NHS as well as in private hospitals and clinics.

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The advertising of medicinal products in the UK is controlled by a combination of legislation and self-regulation through industry associations’ codes of practice.

Part 14 of the Human Medicines Regulations 2012 (the UK Regulations) contains the key statutory provisions relating to medicines’ advertising, and serves to implement Titles VIII and VIIIa of EU Directive 2001/83/EC on the advertising of medicines for human use. In addition to the UK Regulations, the following legislation regulates particular aspects of medicines advertising in the UK:

• the Bribery Act 2010 contains certain provisions that are relevant to interactions between industry and healthcare professionals (HCPs), government officials and other stakeholders;
• the Enterprise Act 2002 implements certain provisions on the enforcement of Title VIII of Directive 2001/83/EC;
• the Cancer Act 1939 prohibits certain advertisements for cancer treatments; and
• the Trades Descriptions Act 1968, the Business Protection from Misleading Marketing Regulations 2008/1276 and the Consumer Protection from Unfair Trading Regulations 2008/1277 contain provisions governing advertising practices generally.

Supplemental guidance to the UK Regulations has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) in its ‘Blue Guide’. Part 14 of the UK Regulations and the Blue Guide set out different requirements depending on whether the advertising in question is aimed at the general public or to HCPs.

In addition to the legislative framework, a self-regulatory system for medicinal product advertising is operated by the Association of the British Pharmaceutical Industry (ABPI) and the Proprietary Association of Great Britain (PAGB). The ABPI’s Code of Practice and the PAGB’s Consumer Code regulate the advertising of prescription-only medicines (POMs) and the advertising of over-the-counter medicines, respectively. The MHRA works with the Advertising Standards Authority, the UK’s independent regulator on matters relating to general advertising across all media, and the Committee of Advertising Practice, the body responsible for writing and maintaining the UK advertising codes.

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Consistent with EU pharmaceutical law, as a general rule, advertising of an unlicensed medicine is prohibited and a medicine cannot be promoted outside its licensed indication(s). All medicines advertising must be consistent with the approved summary of product characteristics (SmPC) of the product.

Insofar as the advertising of medicines to HCPs who are persons qualified to prescribe or supply (PQPS) medicines is concerned, regulations 294 to 300 of the UK Regulations set out requirements relating to a variety of activities including internet advertising, the provision of samples and the conduct of medical sales representatives.

The advertising of POMs to PQPS must be accurate, balanced, fair, objective and unambiguous. It must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly. It must not mislead, either directly or by implication, and must be sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of the medicine.

All advertisements of medicinal products aimed at PQPS must contain the essential information set out in regulation 294 and Schedule 30 of the UK Regulations. These requirements include an obligation for the marketing authorisation holder to:

• state one or more of the licensed indications in the advertisement;
• list the active ingredients;
• summarise the main points in the SmPC relating to dosage, method of use, adverse reactions, precautions, relevant contraindications and, where it is not obvious, method of administration;
• state the classification of the medicinal product, for example, POM, pharmacy or over-the-counter;
• state the actual product name, active ingredients, licence number, name and address of the licence holder and cost of the product; and
• refrain from stating or implying that a medicine is ‘safe’ or ‘new’ (except in certain specified circumstances).

Regulation 300(1) of the UK Regulations moreover prohibits the supply, offer or promise of any gift, pecuniary advantage or benefit to PQPSs in connection with the promotion of medicinal products, unless it is inexpensive and relevant to medical practice. Breach of regulation 300(1) is a criminal offence.

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Regulations 282 to 293 of the UK Regulations govern advertising aimed at the general public.

The advertising of POMs to the general public is prohibited. Factual and non-promotional press releases relating to POMs are permitted, as long as their content is newsworthy and they provide an appropriate context relative to the use of the medicine and the population for which it is authorised.

Over-the-counter and general sales list medicines may be advertised to the public subject to certain requirements set out in regulation 291 of the UK Regulations and the guidance provided in Annex 3 of the Blue Guide, including that the advertisements:

• are consistent with the SmPC of the medicines concerned and are not misleading;
• refrain from suggesting that the medicine will enhance the health of a person not suffering from a disease or injury, or that the effects of the medicine are guaranteed or the same as or better than another identifiable treatment;
• refrain from implying that medical consultation is unnecessary or quote recommendations by HCPs or celebrities; and
• are not directed principally at persons aged under 16.

The UK Regulations also set out rules concerning the form and content of advertisements aimed at the public. Products must be clearly identified as medicinal products, and information regarding the correct use of the product and an express invitation to read the SmPC must be included. Pursuant to regulation 293 of the UK Regulations, the sale or supply of medicinal products to the public for promotional purposes is also prohibited.

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The MHRA Advertising Standards and Outreach Unit’s latest annual report notes that 155 complaints were received by the MHRA in 2017, which shows a slight decrease from the 2016 total of 171 complaints. Consistent with previous years, over 80 per cent of complaints received by the MHRA concerned advertising of POMs to the public. Around 40 per cent of complaints were submitted by competitors, demonstrating a downward trend from the previous year. Complaints regarding advertisements of botulinum toxin products (eg, Botox) continued to feature prominently. An increase was observed in the number of complaints received about advertising on social media such as Facebook and Twitter, which accounted for about one-third of all complaints.

The issues reported to the Prescriptions Medicines Code of Practice Authority (PMCPA) are of a more varied nature. These complaints relate to various forms of interactions between pharmaceutical companies and other stakeholders, including advisory board and other meeting arrangements, the provision of hospitality to HCPs, journal advertisements and discount schemes.

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It is a breach of the UK Regulations to issue promotional material for a licensable medicine before the licence is granted, or for the off-label use of a licensed product that goes beyond the scope of its licence.

In exceptional circumstances, limited factual information regarding new treatments that are expected to give rise to significant changes in costs (compared to the costs of currently available treatments) may be disseminated by manufacturers to persons with responsibility for health budgetary decisions, such as health authorities. Manufacturers may also provide relevant factual information concerning unlicensed medicines or off-label use where this is required by certain national public advisory bodies.

The general prohibition on advertising of unlicensed medicines does not prevent the communication of a factual answer to an unsolicited question about an unlicensed medicine or off-label use. However, manufacturers must take care not to engage in activities that appear to be designed to solicit such questions, which would likely be regarded as promotion and therefore in breach of the UK Regulations.

Under the UK Regulations, licensed manufacturers and suppliers of unlicensed medicines (specials) may send out price lists to HCPs to whom the price of specials may be relevant. No product claims should be included in the price list. Typically, a price list would include the active ingredient, strength, dosage form, pack size and price for each product listed.

Companies may promote the service they provide but any proactive display of information about specials, for example at a conference stand, is likely to be seen as promotional.

The ABPI Code (Supplementary Information to Clause 3) recognises that the promotion of medicines at international meetings held in the UK may sometimes pose problems with regard to medicines or indications for medicines that are not licensed in the UK although they are licensed in another major industrialised country. The display and provision of promotional material for such medicines is permitted, subject to certain conditions being met.

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The pharmaceutical industry’s collaboration with HCPs is governed by a combination of UK domestic law (implementing EU law) and industry self-regulatory regime. The self-regulatory regime is provided in guidance notes and codes of practice. The governing regulatory framework does not distinguish between the outpatient and inpatient sectors and therefore apply equally to all practising HCPs.

In addition to the UK Regulations (see question 3), the instruments (statutory or otherwise) that are particularly relevant to guiding collaborations between the pharmaceutical industry and HCPs in the UK include:

• the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), which govern the conduct of clinical trials;
• the General Data Protection Regulation, which ensures the protection of patients’ and clinical trial subjects’ personal data, as supplemented by the UK Data Protection Act 2018;
• the Bribery Act 2010;
• ABPI Code of Practice and guidance notes:
• Clause 20 of the 2016 ABPI Code, which addresses joint working between pharmaceutical companies and the NHS;
• the ABPI Guidance Notes on Joint Working Between Pharmaceutical Companies and the NHS and Others for the Benefit of Patients (2009);
• the ABPI Quick Start Reference Guide for NHS and Pharmaceutical Industry Partners (2012); and
• the ABPI guidance Joint Working with the Pharmaceutical Industry, guide and case studies (2013);
• the General Medical Council’s ‘Good Medical Practice’ guidance (2013), which provides guidance to doctors on standards of professional conduct and medical ethics;
• the General Pharmaceutical Council Standards for Pharmacy Professionals (2017); and
• the Department of Health and NHS Best Practice Guidance on Joint Working between the NHS and Pharmaceutical Industry and Other Relevant Commercial Organisations (2008).

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All collaborations between the pharmaceutical industry and HCPs must, in principle, be for the benefit of patients, although the arrangement may also benefit the parties to the collaboration. Collaborations should typically take place at an organisational level rather than with individual HCPs.

The ABPI Code sets out rules regarding gifts, inducements, promotional aids and hospitality provided to members of the UK health professions. There must never be any benefit provided to such persons by way of an inducement to prescribe, supply or recommend a medicine. Hospitality must also be strictly limited to the main purpose of any event in connection with which the hospitality is offered, and the level of subsistence offered must not exceed the level that the recipients would normally pay for themselves.

Sponsorships by pharmaceutical companies must be disclosed, and declarations of sponsorships made in publications must be sufficiently prominent to ensure that readers are aware of it at the outset.

The UK Regulations do not include a requirement for companies to make publicly available information about payments or other transfers of value provided to HCPs, patient organisations or healthcare organisations. These requirements have been agreed by the industry on a voluntary basis under the ABPI self-regulatory system.

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As indicated in question 6, complaints received by the PMCPA concern a variety of interactions between manufacturers and HCPs. The PMCPA’s published case reports confirm that complaints commonly involve the arrangements and conduct of meetings with HCPs, such as advisory board meetings, misleading promotional materials or promotional events which are disguised as educational seminars.

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Regulations 280 to 293 set out the restrictions on advertising aimed at and interactions with the general public, which includes patients and patient organisations. Clause 27 of the ABPI Code (enforced by the PMCPA) sets out the conditions under which pharmaceutical companies may collaborate with patient organisations.

When working with patient organisations, pharmaceutical companies must ensure that its involvement is documented by a written agreement between the parties and that all of the arrangements comply with the ABPI Code. This includes the need to declare sponsorship and the prohibition on advertising POMs to the public. Pharmaceutical companies that are members of the ABPI must make publicly available, at a national or European level and on an annual basis, a list of patient organisations to which they provide financial support or significant non-financial support or both.

Restrictions apply with respect to the use of a patient organisations’ logo or proprietary material. Companies must also not seek to influence the text of patient organisation material in a manner favourable to its own commercial interests. However, this does not preclude a company from correcting factual inaccuracies.

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Yes. Alleged infringements of UK or EU competition law may be the subject of complaints to the Competition and Markets Authority (CMA), a body established under the Enterprise and Regulatory Reform Act 2013. The CMA may also investigate a matter of its own volition.

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Yes. Actions for civil remedies may be brought in the High Court by anyone with sufficient interest, such as a competitor, supplier or customer who has suffered loss or damage as a result of an alleged infringement of UK or EU competition law. These actions may be stand-alone or follow-on, and the available remedies include damages or an injunction or both.

In addition, any person who has suffered loss or damage as a result of an infringement of UK or EU competition law may bring a damages action before the Competition Appeal Tribunal (CAT). These are follow-on actions only. Claims on behalf of individuals may also be made to the CAT by certain recognised representative bodies acting on behalf of identified consumers.

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As indicated in question 8, interactions and arrangements involving the provision of hospitality, gifts and inducements to prescribe to HCPs (or other decision-makers within healthcare organisations) are also subject to the Bribery Act 2010. Three particular offences thereunder should be borne in mind, namely:

• bribing or accepting a bribe from another person (sections 1 and 2);
• failing to prevent bribery (only corporate bodies) (section 7); and
• bribing a foreign public official (section 6).

The Bribery Act 2010 is enforced by the Serious Fraud Office (SFO). The SFO has issued a memorandum of understanding with the ABPI and the PMCPA, which confirms that the SFO sees self-regulation under the ABPI Code as the first means of dealing with complaints relating to the issues under the scope of the ABPI Code. Although both bodies deal with complaints whatever their source, the SFO’s focus is on dealing with complaints not covered by the ABPI Code and that meet its criteria of serious fraud.

Closely interlinked with the Bribery Act is the Procurement Directive 2014/24/EU, which provides for a sanction of debarment from public procurement to any candidate who has been convicted of an offence of which the authority is aware. In the UK, the debarment from public procurement is discretionary where a company is convicted of failing to prevent bribery by an associated person. However, it is mandatory if a company is convicted of active bribery.

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The rules relating to medical devices are similar to, but less detailed and less onerous in some aspects, than those relating to the pharmaceuticals sector. It has been said that the reason for the seemingly more relaxed approach is because of a presumed lower risk of misuse as compared to medicines.

Similar to the pharmaceuticals sector, the rules applicable to medical devices also derive from a combination of legislation and self-regulation. The Medical Devices Regulations 2002 implement the EU Medical Devices Directives and although they address issues of labelling, display, information to be supplied and the CE mark, they do not regulate advertising material per se. The advertising of medical devices is therefore primarily governed by general consumer legislation, such as the Sales of Goods Act 1979, the Consumer Rights Act 2015, the Consumer Protection from Unfair Trading Regulations 2008 and the Business Protection from Misleading Marketing Regulations 2008.

The self-regulatory regime for the medical technology or devices sector is primarily controlled by the Association of British Healthcare Industries (ABHI) in accordance with the principles set out in its Code of Business Practice, which requires any advertising of medical devices to be accurate, balanced, fair, objective and unambiguous. The ABHI Code, along with the Eucomed Code of Ethical Business Practice, govern collaborations and other interactions between medical device manufacturers and HCPs. The Bribery Act 2010 is also applicable to this industry sector.

The new EU Medical Devices Regulation (MDR) and the In Vitro Medical Devices Regulation (IVDR), which entered into force on 26 May 2017, are intended to harmonise the increasingly divergent interpretations of the existing framework and thus improve the protection offered to EU patients who use these products. These regulations, which are directly effective, will only apply after a transitional period, namely three years for the MDR and five years for the IVDR. While the current framework of rules (outlined above) will continue to apply during the transitional period, it is important that manufacturers of medical devices familiarise themselves with and prepare for the requirements contained in the new regulations, so as to avoid being non-compliant at the time when these begin to apply (in 2020 and 2022 for medical devices and in vitro devices respectively).

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The granting of marketing authorisations and the placing of medicines on the UK market is governed by the UK Regulations. The UK Regulations implement the relevant EU law concerning granting of marketing authorisations. The relevant procedures are set out in Title III of Directive 2001/83/EC and Title II of Regulation (EC) No. 726/2004 (as amended). In addition, Regulation (EC) No. 1901/2006 addresses the authorisation of medicinal products for paediatric use, while Regulation (EC) No. 1394/2007 contains specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

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In the UK, the MHRA is the competent authority for granting national marketing authorisations. It is responsible for applications made through the national, mutual recognition or decentralised procedures (see question 18).

The European Medicines Agency (EMA), established by Regulation (EC) No. 726/2004, is the European executive agency responsible for evaluating marketing authorisations submitted through the centralised procedure. The EMA advises the European Commission and member states of the EU and European Economic Area (EEA) on all matters concerning supervision of medicinal products.

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A medicine can be authorised for marketing in the UK through the following alternative regulatory routes:

• the centralised procedure (CP);
• the decentralised procedure (DCP);
• the mutual recognition procedure (MRP); and
• the national procedure.

CP, DCP and MRP are regulatory procedures created under EU pharmaceutical law that seek to achieve harmonisation and coherence of the regulatory decision on granting and supervision of a marketing authorisation.

A successful CP application results in a single marketing authorisation that is valid in all EEA countries. Applications through the CP are submitted directly to the EMA for scientific evaluation. The scientific evaluation is assisted by the EMA’s relevant scientific committees resulting in adoption of an opinion, which will form the basis for the European Commission to issue a binding Commission decision. The European Commission serves as the EU licensing authority to grant marketing authorisations through CP in the EU.

The CP is the mandatory procedure where the application concerns a medicinal product that falls within the scope of the Annex to Regulation 726/2004, namely:

• advanced therapy medicinal product (ATMPs) such as gene therapy, cell therapy and tissue-engineered products;
• medicines derived from biotechnological processes;
• orphan medicines (medicines intended to treat rare human diseases); and
• new active substances with particular therapeutic indications (for example, cancer or HIV/AIDS).

Where a product does not fall within one of the above categories, companies may nevertheless use the CP provided that: (i) the new medicine concerned represents a significant therapeutic, scientific or technical innovation; (ii) if its authorisation would be in the interest of public or animal health; or (iii) if the medicine is a generic version of a medicine previously authorised through the CP.

Pharmaceutical companies may apply for the authorisation of a medicine through the DCP that has not yet been authorised in any EEA country to be simultaneously authorised in multiple EEA countries (provided that the medicine does not fall within the mandatory scope of the CP). A reference member state leads the assessment of the DCP application and provides the other member states with a draft assessment report and an SmPC. The reference member state liaises with the member states where the applicant wishes to market the product. When an agreement is reached, the application is approved by the individual member states concerned resulting in the grant of national marketing authorisations. If an agreement to approve the application is not reached within 210 days, the matter is referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) (if the medicine is intended for human use) and potentially to the Committee for Medicinal Products for Human Use (CHMP).

The MRP is used in cases where a marketing authorisation has already been granted in one EEA country (this country would become the reference member state for MRP purposes) and an additional marketing authorisation is progressively granted in one or more other EEA countries. Similar to the DCP, the reference member state produces an assessment report and a SmPC for review and approval by the concerned member states. Provided there is no objection, the existing marketing authorisation is recognised and additional marketing authorisations are granted on that basis. If there is disagreement, the matter is referred to the CMDh and then the CHMP.

Provided that the product does not fall within the scope of the mandatory CP and that there is no commercial interest for the product to be marketed in the other EEA countries, an application for marketing authorisation may be submitted nationally to the competent authority. In the UK, the competent authority is the MHRA. In practice, the national procedure is of limited application for new innovative products.

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Other than in exceptional cases where the MHRA has granted an exemption on grounds of public health, a UK marketing authorisation will cease to be in force if the product to which it relates is not placed on the market in the UK within the first three years following the date on which it was granted (see regulation 67 of the UK Regulations). A marketing authorisation will also be invalidated if the product to which it relates has been placed on the market but has not been sold or supplied for a period of three consecutive years.

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Part 10 of the UK Regulations specify exemptions to the general requirement for a marketing authorisation. A medicine may be marketed, notwithstanding that a marketing authorisation has not been granted, in limited circumstances including:

• if the product is supplied in response to an order from an HCP for use by his or her individual patient on a special-needs basis (specials) (see question 21);
• if the medicine is manufactured and assembled in accordance with the instructions of an HCP; or
• if the product is manufactured by mixing authorised medicinal products with other authorised medicinal products, or with substances that are not medicinal products, provided that any authorised medicinal products used are subject to general sale.

There are also exemptions in relation to ATMPs prepared on a non-routine basis, and certain radiopharmaceuticals.

Products supplied under these exemptions cannot be advertised and must be manufactured and controlled according to specific requirements including proper record-keeping in relation to their supply.

The UK also operates a parallel import licensing scheme, which allows medicines authorised in other EEA countries to be marketed in the UK provided that the imported products have no therapeutic difference from equivalent products authorised in the UK. Companies wishing to import medicinal products must submit a parallel import licence application to the MHRA’s Parallel Import Section (unless they are products authorised through the CP, in which case the application for parallel distribution should be made to the EMA).

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Yes. Pursuant to the UK Regulations, an unlicensed medicine may be prescribed to an individual patient (often called ‘named patient supply’, although the patient does not, in fact, have to be named by the HCP seeking supply of the unlicensed product), subject to certain conditions in circumstances where a patient has a special need for the medicine and there is no existing alternative. This may be appropriate if the medicine is still undergoing clinical trials and a marketing authorisation has not yet been granted or, in respect of uncommon diseases, where there are no suitable medicines available. This provision implements article 5(1) of Directive 2001/83/EC.

In addition, the UK government launched the Early Access to Medicines Scheme (EAMS) in 2014. This is a voluntary, non-statutory scheme that runs in parallel to the UK Regulations, and is intended to allow patients to access innovative unlicensed or off-label medicines earlier than the current marketing authorisation procedures permit. The scheme applies to medicines that target life-threatening or seriously debilitating conditions for which there are no existing treatments, or where existing treatments are unsatisfactory. However, there must be sufficient quality, safety and efficacy data available to show that the risk or benefit profile of the product is positive, and that the medicine represents a significant advance in the treatment of an unmet need. As a result, products will normally be eligible for EAMS only after completion of Phase III clinical trials.

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The prices of branded health service medicines supplied for use in the UK (whether for use in the outpatient or inpatient sectors) are controlled through the Pharmaceutical Price Regulation Scheme (PPRS) or the parallel statutory scheme.

The PPRS is a voluntary scheme agreed between the Department of Health and the ABPI under section 261 of the National Health Service Act 2006 (the 2006 Act). The scheme is renegotiated about every five years; the current version of the PPRS is the 2014 scheme.

The PPRS is adhered to by members of the ABPI and non-members who have voluntarily agreed with the Department of Health to be subject to it. Scheme member companies are exempted from statutory price regulation by reason of their voluntary compliance with the PPRS. While companies are, in principle, free to set their own list prices, in practice the PPRS assumes that prices at product launch will be approximate to the product’s anticipated value as assessed by National Institute for Health and Care Excellence (NICE) in England (and its equivalents in the devolved countries) pursuant to a technology appraisal recommendation. Price increases proposed by scheme member companies must be approved by the Department of Health and be compliant with the PPRS regime. Although the PPRS does not explicitly fix prices for branded medicines, companies with sales to the NHS that exceed a set value threshold are required to submit data on those sales from which a determination will be made as to the amount to be reimbursed. The PPRS requires manufacturers to make quarterly rebate payments at pre-agreed levels. These rebates are payable subject to certain conditions; for example, manufacturers with sales to the NHS of less than £5 million do not have to make rebates.

The statutory scheme, under sections 262 to 264 of the 2006 Act, is set out in the Health Service Branded Medicines (Control of Prices and Supply of Information) No. 2 Regulations 2008 (as amended). The statutory scheme is applicable only to POMs. All companies supplying branded health service medicines who are not members of the PPRS (representing about 10 per cent of branded medicines), are automatically subject to the statutory scheme. The Health Service Medical Supplies (Costs) Act received Royal Ascent, and thereby became national law, on 27 April 2017. The Act was prepared in recognition of the fact that the mechanism of controlling prices in the statutory scheme is less effective in terms of the level of saving it makes than the mechanism in the voluntary scheme, leading to some companies leaving the voluntary scheme in favour of the statutory scheme.

There is no price regulation of generic medicines. However, NHS services are reimbursed for medicines dispensed at nationally set prices, which has the effect of controlling prices.

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See question 22.

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There is no formal reimbursement step required before medicines may be prescribed for NHS patients. However, usage of medicinal products is controlled through inclusion in local formularies defined by CCGs or NHS Trusts. In England, NICE carries out appraisals of certain new products (and existing products in some cases) and issues recommendations based on health technology appraisals based upon an assessment of clinical and cost-effectiveness in order to determine whether such products should be used to treat NHS patients. Such recommendations are important for products to be adopted by CCGs or NHS Trust formularies. In practice, a medicinal product that is not included on the relevant formulary is unlikely to be used or its use is limited to very exceptional circumstances.

Pharmacies are reimbursed by the NHS for the actual cost of products they dispense, based on the published price of medicines as set out in the Drug Tariff (or, where no reimbursement price is set in the Drug Tariff, at the manufacturer’s list price). This is the case in both the outpatient and inpatient sectors.

NHS Trusts are paid by their local CCGs, based on procedures actually performed, and the cost of the procedure is fixed in the ‘national tariff’, which includes standard medicines, but not many high-cost products (these are instead charged separately). The statutory basis for the national tariff is the Health and Social Care Act 2012.

HCPs can issue an NHS prescription for licensed and unlicensed products (in the case of ‘specials’ and any prescribed off-label use), except in respect of those that feature on the ‘blacklist’. The blacklist can be found in Schedule 1 to the NHS (General Medical Services Contracts) (Prescription of Drugs, etc) Regulations 2004 and is reproduced in Part XVIIIA of the Drug Tariff. It primarily lists health supplements and cosmetic treatments that the patient must pay as the cost of dispensing is not reimbursed by the Department of Health.

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Overall responsibility for pricing and reimbursement matters lies with the Department of Health. However, as indicated in questions 22 and 24, NICE (and its equivalents in the devolved jurisdictions) conducts assessments that form the basis of recommendations to the NHS regarding the clinical and cost effectiveness of medicinal products.

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No, there is no statutory requirement for manufacturers or distributors to offer discounts on the medicinal products they supply.

However, as indicated in question 22, the PPRS and the various statutory powers under the National Health Service Act 2006 indirectly regulate the prices set by manufacturers for the supply of products to the NHS by regulating profits that pharmaceutical companies are allowed to make on their sales. Discounts by pharmaceutical manufacturers and distributors are, however, common practice in the UK.

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The Falsified Medicines Directive 2011/62/EU (FMD) came into force in the EU on 2 January 2013. It introduced harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. The new rules include:

• obligatory safety features, comprising a unique identifier and an anti-tampering device, on the outer packaging of some medicines (these were detailed in Commission Delegated Regulation (EU) 2016/161 which was published in the Official Journal on 9 February 2016 and becomes directly applicable on 9 February 2019);
• a common, EU-wide logo to identify legal online pharmacies;
• tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
• strengthened record-keeping requirements for wholesale distributors.

The bulk of the FMD was transposed in the UK by the Human Medicines (Amendment) Regulations 2013, which became effective on 20 August 2013. However, provisions relating to safety features were carved out and do not have to be implemented until 9 February 2019.

Owners of certain intellectual property rights can impede the production and supply of counterfeit medicines by taking private civil actions against infringers, or by applying to restrict the importation of suspected counterfeit goods under Regulation (EU) No. 608/2013. The UK customs authority, HMRC, is responsible for reviewing applications and detaining suspected counterfeit products at the UK border. The owner of the intellectual property rights that the goods are alleged to infringe may then elect to commence proceedings.

More generally, the MHRA has powers under the UK Regulations to investigate cases and, where appropriate, bring criminal prosecutions in respect of the sale and supply of unlicensed medicines.

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As part of its ‘Pharmaceutical Package’, the European Commission aims to provide a clear framework for the dissemination of information by marketing authorisation holders about their POMs to the general public. In view of this aim, the European Commission published a legislative proposal in December 2008 concerning the provision of information to patients. However, following protracted but ultimately unsuccessful negotiations, the proposal was abandoned in May 2014. The UK authorities have not publicised any intention to take additional measures to facilitate the general public’s access to information about POMs.

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The EU legal framework of pharmacovigilance for medicinal products for human use is provided for in Directive 2001/83/EC for all medicinal products authorised under EU pharmaceutical law, and Regulation (EC) No. 726/2004 for centrally authorised products. The legislation was amended by Regulation (EU) No. 1235/2010 and Directive 2010/84/EU. The changes introduced by the Directive were transposed into UK law by the UK Regulations, while Regulation (EU) No. 1235/2010 is directly applicable.

The new pharmacovigilance legislative package has applied since July 2012 across all EEA countries. The regulatory tools made available under the revised legislation include risk-management plans, post-authorisation studies, signal detection and management at EU level, periodic safety update reports assessment and reviews of medicines through referrals. The legislation creates a Pharmacovigilance Risk Assessment Committee, which is responsible for assessing and monitoring safety issues for human medicines.

Under the new legislative package, marketing authorisation holders are also required to maintain a pharmacovigilance system master file that is permanently available for submission or inspection by the national competent authority.

The process of reporting adverse drug reactions (ADRs) has been centralised through electronic submissions to the EudraVigilance database. Previously, reports were made via the individual national competent authority. Since September 2013, it has been mandatory to display a black inverted triangle on the product information of medicines that are being monitored particularly closely by regulatory authorities. With this measure, the European Commission aims to improve the safety of medicines and to highlight to patients the importance of reporting suspected ADRs.

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The Department of Health administers the UK’s national immunisation programme, and has set out relevant considerations and guidance in its publication ‘Immunisation against infectious disease’ (also known as the Green Book).

Vaccination is not mandatory, and explicit consent must be obtained before any immunisations are administered. The NHS has issued a recommended vaccination schedule for children up to the age of 18, adults over the age of 65 and people who fall into certain risk groups (eg, pregnant women and healthcare workers). Certain travel vaccines are usually provided free of charge by the NHS (eg, hepatitis A, typhoid and cholera vaccines) whereas other travel vaccines must be arranged privately (eg, yellow fever vaccination).

GPs must maintain a record of patients’ vaccination history, which may require them to draw on information from other healthcare bodies and institutions to produce a vaccination history. Individuals administering vaccinations must have received training in the management of anaphylaxis, and must have immediate access to appropriate equipment and to adrenaline (epinephrine).

The reimbursement regime surrounding vaccinations is governed by the General Medical Services Contract (GMS contract) made pursuant to the NHS (General Medical Services Contracts) Regulations 2004. This contract acts as the basis for arrangements between the NHS Commissioning Board and providers of general medical services in England. Under the GMS contract, vaccines and immunisations have been paid for through various mechanisms depending on which services a practice provides. Most payments are made through the ‘global sum’, although certain directed enhanced services for patients at risk of infection are reimbursed separately. The global sum is a distribution of the NHS core funding to practices according to the needs of their registered list of patients and the costs of providing services defined as ‘essential’ and ‘additional’ services in the GMS contract.

NHS statistics indicate that, in 2015/16, over 90 per cent of children in England completed the recommended immunisations by the age of two years, with little variation between the four nations across all vaccines.

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As illustrated above, the regulation of medicines and medical devices in the UK is currently subject to both EU and UK legislation and oversight. In the event of a no-deal Brexit, full regulatory authority will pass to the UK, and the European legislation will cease to apply to the UK on 29 March 2019 (exit day), although UK legislation that implements EU law will remain in force. Under the EU (Withdrawal) Act 2018, all existing EU rules will be converted into UK law at the moment of exit to the extent they are not already part of UK law.

With regard to medicines, while the bulk of EU law is already part of UK domestic law thanks to the Human Medicines Regulations, in the longer term, there will be changes to the Regulations to reflect certain practical implications of the UK’s withdrawal from the EU.

For example, on 23 August 2018, the MHRA issued guidance indicating that existing centralised marketing authorisations will be converted automatically to UK marketing authorisations on 29 March 2019, unless marketing authorisation holders opt out. On the other hand, existing products authorised under the decentralised and mutual recognition procedures will be unaffected as marketing authorisation holders already hold a UK marketing authorisation. The UK is planning to adopt the current EU data and market protection periods. The MHRA will continue to require a named individual in the UK who can be contacted in the event of a safety issue, and who has the authority to require independent retesting of medicines or to withdraw a product from the market.

The UK will continue to use the EU Good Manufacturing Practice and Good Distribution Practice guidelines and will align with the EU/EEA exhaustion regime to ensure that parallel imports of goods, including pharmaceuticals, can continue from the EU/EEA. The MHRA has announced plans for a consultation on some of the key proposed legislative changes, which is to be held in the early autumn.

With regards to medical devices, again, the bulk of EU legislation is already implemented into UK law through the MDR. In the event of a no-deal Brexit, the MHRA’s guidance indicates that the UK will recognise EU CE-marked medical devices for a limited time. However, the MHRA’s guidance makes clear that this is a temporary position and that, in the longer term, the process for bringing a medical device onto the UK market will be subject to consultation.

As UK-based notified bodies will no longer be able to assess the conformity of medical devices for the purposes of the EU legislation, the MHRA will no longer be able to oversee notified bodies.

The UK will comply with ‘all key elements’ of Regulations 2017/745 and 2017/746; although the MHRA guidance does not detail which elements of the Regulation the MHRA considers to be ‘key’. The MHRA will continue to monitor the safety of medical devices on the UK market, but will have authority to take decisions regarding the marketing of such devices in the UK without reference to the EU regulatory network or the European courts.

With regards to data-driven health and care technology, on 5 September 2018 the Department of Health published a new code of conduct. The code outlines 10 key principles for safe and effective digital innovations, and five commitments from the government to ensure that the health and care system is ready and able to adopt new and innovative technology at scale. These are based on a significant amount of engagement with industry, research and academia, and are designed to create a trusted environment.

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