Regulatory, Pricing and Reimbursement Overview
All about regulatory, pricing and reimbursement overview in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
Although the United Kingdom (UK) is negotiating its withdrawal from the European Union (EU), as of now, the UK remains a member of the EU and so subject to all EU legislation, including that on medicines and medical devices. Running in parallel to, and closely aligned with the EU legislation and bodies, are the UK’s national legislation and bodies. Both systems are described below. As the regulation of veterinary medicines is similar to that for human medicines, this Handbook will focus on human medicines only.
The EU legal framework is based on Regulation (EC) No. 726/2004 (as amended), which established the European Medicines Agency (EMA). The EMA has been operating for over 24 years and acts as the European regulatory authority with jurisdiction over drugs (human and veterinary), biologicals and medical devices across the EU. However, EU-wide marketing authorisations for medicines are actually granted by the European Commission, on the EMA’s advice, rather than by the EMA itself. Within the EMA, the Committee for Medicinal Products for Human Use (CHMP) is responsible for the evaluation of medicines for human use under the centralised procedure (discussed in the answer to Question 3) as well as providing advice to companies developing new medicines and preparing scientific guidelines and regulatory guidance for applicants for marketing authorisations.
The UK’s domestic regulatory authority is the Medicines and Healthcare Products Regulatory Agency (MHRA), which was established in 2003. It is a government agency and is responsible for regulating medicinal products (for human and veterinary use) and medical devices in the UK as well as blood and blood products and generally regulating the pharmaceutical market in the UK (e.g. through manufacturers and wholesalers licences, the regulation of clinical trials conducted in the UK and the investigation of breaches of licences and of harmful incidents with associated enforcement powers). There are two independent bodies of experts that advise the MHRA, the Commission on Human Medicines and the Committee on the Safety of Devices.
If and when the UK leaves the EU, the MHRA will become the sole authority for the UK.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
Under the EU legal framework, healthcare can be split into two major groups: (i) pharmaceuticals (including drugs and biologicals); and (ii) medical devices. The legal requirements for the authorisation of pharmaceuticals and medical devices are very different, even though the overall aim of the regulatory regimes for both categories is to ensure that products are safe and effective for patient consumption or use.
As said above, the main EU legislation that governs the licensing (and monitoring) of medicines is Regulation (EC) No. 726/2004 (as amended) and Directive 2001/83/EC. The latter is implemented in the UK through the Human Medicines Regulations 2012 (SI 2012/1916) (as amended) (HMR), which also consolidates much of the prior legislation relating to medicines including relevant parts of the Medicines Act 1968. The HMR therefore governs matters such as the authorisation, manufacturing, importation, distribution, supply and advertising of medicines as well as pharmacovigilance.
(ii) Medical Devices
Generally medical devices cannot be marketed in the UK (or in the EU) without a CE mark. However, the EU legislative framework for medical devices has recently been revamped through Regulation (EU) 2017/745 on Medical Devices (EU MDR) and Regulation 2017/746 on In Vitro Diagnostic Medical Devices (EU IVDR), both of which came into force on 25 May 2017. They are subject to 3- and 5-year transitional periods respectively, during which time devices can be placed on the market either under the existing legislation or under the Regulations. The existing legislation being replaced by these Regulations is, for medical devices, Council Directives 93/42/EEC (medical devices) and 90/385/EEC (active implant- able medical devices), and, for in vitro devices, Directive 98/79/EC and Commission Decision 2010/227/EU (collectively the “Medical Devices Directives”). The Medical Devices Directives were mostly transposed into UK law through the Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK MDR).
(b) Pricing and Reimbursement
While manufacturers can be said generally to have freedom of pricing, there are a number of tools used to ensure value for money and cost control for medicine pricing. Thus, for branded medicines supplied through the UK’s National Health System (NHS), price is regulated by either the Voluntary Scheme for Branded Medicines Pricing And Access (the “Voluntary Scheme”), which applies for 5 years from 1 January 2019 replacing the prior 5-year voluntary schemes known collectively as the Pharmaceutical Price Regulation Scheme, or by what is known as the “Statutory Scheme“, the current version of which came into effect on 1 April 2018. These pricing schemes are discussed further in the answer to Question 12 and reimbursement in the answer to Question 13.
The above schemes do not apply to medicines that are supplied on private (i.e. non-NHS) prescriptions or that are otherwise supplied outside the NHS system (described in the answer to Question 10).
The price of unbranded generic drugs is set by the Drug Tariff. This is a monthly price list produced by the NHS of the drugs and devices that have been approved for reimbursement. The prices are set by the NHS Prescription Services by a number of mechanisms, typically by reference to competing products.
The Health Service Medical Supplies (Costs) Act 2017 was introduced to give the government additional powers to control the price of drugs, particularly unbranded generic products, and so prevent manufacturers from de-branding in order to significantly increase prices.
(ii) Medical devices
A medical device manufacturer is generally free to set its own price for its product (subject to negotiation with the NHS) unless the device falls within one of the 4 categories that are covered by Part IX of the Drug Tariff. Part IX covers dressings, incontinence devices, stoma devices and chemical reagents. The “entry price” for Part IX devices will generally be set by reference to similar products, though the manufacturer can make representations as to why the price should be different and for annual price increases. The actual price paid by dispensers such as pharmacies, doctors etc. to the manufacturer (or wholesaler) can be negotiated but the Drug Tariff price, and the fact that a patient would need to pay privately for any device costing more than that, means that the Drug Tariff price will generally be followed.
3. What are the steps to obtaining authorization to develop, test, and market a product?
(a) Clinical Trials & Investigations
The authorisation of clinical trials for medicines is discussed in Chapter 2.
(ii) Medical devices
Medical devices are divided into Classes I, IIa, IIb and III on a risk-based system with the criteria for classification being set out in Annex IX of Council Directive 93/42/EEC. Class I are low risk, Classes IIa and IIb medium risk and Class III high risk. The higher the risk, the more rigorous the assessment required.
Thus Class I products may only require a clinical evaluation (as also set out in the Medical Devices Directives). The evaluation is aimed at demonstrating the safety and performance of the device when used as intended, without being unduly burdensome, and the results are set out in a report for use in support of the CE marking. Evaluations should, though, be repeated periodically throughout the life cycle of the device.
Other Class I devices and higher risk Classes require a clinical investigation as part of the process for obtaining a CE mark. The requirements for a clinical investigation are set out in the Medical Devices Directives and are to assess the safety and clinical performance of the device and whether it is suitable for the intended purpose and populations. A clinical investigation should be notified to the MHRA at least 60 days before it is due to start. The MHRA will assess the safety and performance of the device and the design of the proposed clinical investigation and at the end of its 60-day assessment period will notify the applicant whether the investigation can proceed or not.
The European Commission issues guidance on the conduct of clinical evaluations and investigations.
There are four principle routes by which a marketing authorisation for a medicine can be obtained, these are:
The centralised procedure (CP) – applications are made to the EMA and result in a single marketing authorisation that is valid in all EU countries as well as Iceland, Liechtenstein and Norway (i.e. in the European Economic Area (EEA)). Certain medicinal products can only be licensed through the CP such as: ‘high tech’ biotechnology treatments, medicines for HIV/AIDS, cancer, diabetes and neurodegenerative diseases and Orphan drugs. This is to ensure that important medicines are readily available in all EU member states.
The national procedure, i.e. an application in a single member state to its competent authority– in the case of the UK, the MHRA. The national procedure is not much used as applicants will usually want to market new products in more than one jurisdiction.
The mutual recognition procedure (MRP) – used when an applicant already holds a marketing authorisation in one EU member state (the “reference member state”) and wishes to obtain authorisations in one or more additional member states. The authority in the reference member state will produce an assessment report and summary of product characteristics (SmPC) for review by the authorities in the additional countries (referred to as the “concerned member states”, who will also suspend any evaluations of their own on the product). If the concerned member states approve, the existing marketing authorisation is recognised and further authorisations are granted in the additional states.
The decentralised procedure (DCP) – the DCP is similar to the MRP but used where the product is not already authorised in any member state and the applicant either does not want to use the CP, or the product is not eligible for that route. One of the proposed member states will be asked by the applicant company to act as the reference member state and produce a draft assessment report and SmPC for agreement with the others (the concerned member states). The authorities in the concerned states may raise questions or objections. Once all the issues are resolved, each member state will issue a marketing authorisation permitting the product to be marketed in its country.
(ii) Medical Devices
The procedures for obtaining CE marking for a medical device are complex and varied, depending on the nature and intended use of the device. The main steps are to:
- classify the medical device;
- conduct the appropriate conformity assessment procedure for the relevant Class of device (this is to show that the device meets the requirements of the Medical Devices Directives);
- produce the technical documentation (essentially a full description of the design, manufacture and intended operation of the device, the risk assessment and conformity documentation);
- apply for certification by a notified body (i.e. a body approved for the issue of CE marks by the MHRA); and
- sign a declaration of conformity.
Certain types of medical devices are also required by Directive 93/42/EEC to be registered with a competent authority, which for the UK is the MHRA.
4. What are the approximate fees for each authorization?
The MHRA sets the level of fees every year in April. For 2019/2020, the fee for the national procedure is £92,753.00 and the fee for the DCP where the UK is a concerned member state is £89,556.00. For an incoming application under the MRP, the MHRA’s fee is £62,421.00.
The EMA’s fee for an application under the CP for a single pharmaceutical form and presentation is from £291,800.00.
The fees charged by notified bodies for CE marking of devices vary from one body to another and depending on the nature of the medical device so that it is not possible to give an indication of fees. The MHRA’s section of the GOV.UK website has a list of UK-based notified bodies with contact details for enquiries (notified bodies based elsewhere in the EU may also be used). In addition, the MHRA charges £100.00 for registration, notification, update or change of registered information.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
A UK marketing authorisation will cease to be in force if the authorised medicine is not placed on the market within 3 years of grant or if the product is not sold or supplied for 3 consecutive years.
Assuming the product is marketed within the 3 years, the marketing authorisation is valid for an initial period of 5 years from the date of grant. At least 9 months before the expiry of those 5 years, the marketing authorisation holder (MAH) can apply for renewal. This requires paying the appropriate fee and filing electronically a consolidated version of the file on the quality, safety and efficacy of the product. If there are no safety concerns upon review of the file, the authorisation can be renewed for an unlimited period whereas, if there are concerns, renewal is for a further 5 years.
Renewal applications for medicines authorised through the national procedure in the UK should be filed at the MHRA and for those authorised by the CP at the EMA. For medicines authorised by the MRP and DCP, renewal applications should be filed with the competent authorities for all relevant members at the same time. If the MAH does not wish to renew an authorisation relating to the UK, it must file a cancellation form with the MHRA and notify the Department of Health & Social Care (DHSC).
CE certifications for medical devices are generally valid for 3 years, though it may only be 1 year for some high-risk devices.
6. How does the authorization process differ between brand- name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
The applications for marketing authorisations under the procedures described in the answer to Question 3 can be “full” applications or “abridged” applications. Full applications are used for new active substances and require sub- mission of a dossier of information, including pharmaceutical tests, preclinical tests and clinical trials. In contrast, abridged applications can be used for medicines containing existing active substances, such as generic products, and avoid the need for such tests and trials. Where the generic product has the same qualitative and quantitative composition and active substances, and the same pharmaceutical form, as an already authorised “reference medicinal product”, and where bioequivalence can be demonstrated, the applicant can instead rely on the results of the preclinical test and clinical trials already on file for that reference medicinal product.
However, the MAH for the reference medicinal product has the benefit of data and market exclusivity periods that limit the ability of generics to rely on its tests and trials. These are:
- an 8 year data exclusivity period in which no application can cite the clinical data;
- a further 2 year period of market exclusivity during which, though a generic applicant can rely on the clinical data to obtain grant of its own marketing authorisation, it cannot place its product on the market (thus effectively giving an originator a 10 year market exclusivity period); and
- a further additional year (giving 11 years of market exclusivity) if a new indication of significant clinical benefit is added to the reference medicinal product or there is a change of classification supported by additional and significant tests and trials conducted within the initial 8 years.
These exclusivity periods are independent of any patent and/or supplementary protection certificate (SPC) protection that may exist in respect of a reference product and prevent the marketing of a generic version.
With regards to differences between local manufacturers and foreign manufacturers – only applicants that are established in the EU can obtain a marketing authorisation. “Established” means for a company, partnership or other body that it must have a registered office in the EU (e.g. for a limited company be registered at the UK’s Companies House or its equivalent in other EU countries).
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
Although the term “combination products” is commonly used within the EU pharma sector, there is no clear definition of “combination” in the EU legislation regulating medicinal products and medical devices. However, the term “medicinal product” used in EU legislation includes combinations of substances for treating or preventing disease, for restoring, correcting or modifying physiological functions or for making a medical diagnosis. Therefore combinations of drugs and drugs + biologics will be authorised through the procedures set out in the answer to Question 3, using the CP where biologics (and biosimilars) are involved. Similarly, if the principle intended action of a medical device + drug combination is achieved by the drug, then the entire product is regulated as a medicinal product.
For medical device/drug combinations in which the drug is integral (e.g. a pre-filled syringe or a patch for transdermal drug delivery) then, if the device is CE marked, the application for a marketing authorisation should include either the CE certificate or a declaration of conformity. If the device is not CE marked, but would need to be if marketed separately from the drug, then the application for marketing authorisation must include an opinion of conformity from a notified body.
If the medical device and drug are simply co-packaged (e.g. a reusable pen for insulin cartridges), then the legislation on CE marking for devices applies to it. The same applies to medical devices that contain a medicinal substance that is ancillary to the proper functioning of the device (though if the ancillary substance is derived from human blood or plasma, or is within the scope of the CP, the notified body must obtain a scientific opinion from the EMA on the quality and safety of the substance before it can issue a CE mark).
8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
The MHRA is responsible for monitoring compliance with medicines and medical device legislation in the UK, including the provisions on licensing, as well as monitoring of the safety and quality of medicines and devices. In addition, the MHRA carries out a sampling scheme for potentially counterfeit products. In these roles the MHRA has extensive powers derived from the HMR (for medicines), the UK MDR and consumer legislation (for medical devices) and the Police & Criminal Evidence Act 1984. Its powers include:
- taking samples of medicines/substances;
- entering and inspecting premises (both routine and unannounced inspections);
- requesting/seizing and/or retaining information/documents;
- seizing/retaining substances/articles; and
- bringing criminal prosecutions.
The MHRA takes a risk-based approach to its compliance monitoring and so, in respect of medicines, factors such as past findings and changes in the organisation of a licence-holder will be used to determine the frequency of routine inspections (the date for which is typically agreed in advance). The MHRA conducts around 1,000 inspections of manufacturers and wholesalers per year.
The MHRA also uses other schemes, such as its Yellow Card Scheme for the reporting of adverse drug reactions, to monitor and improve drug safety. Adverse reactions can be reported by anyone under the Scheme but is usually by healthcare professionals.
The MHRA cooperates closely with other UK bodies such as the police, customs and Trading Standards (which enforces consumer protection legislation) as well as the EMA (for example, notifying it of the withdrawal or suspension of a national marketing authorisation) and bodies outside the EU such as the FDA and Drug Enforcement Administration in the US.
The EMA and European Commission can take enforcement action under Regulation (EC) No. 658/2007 (as amended) in respect of marketing authorisations approved through the CP where an MAH is in breach (infringement) of obligations to which its authorisation is subject. The infringement must have significant public health implications within the EU, have effects in more than one member state or involve the EU’s interests before the action will be taken. The investigation phase is conducted by the EMA, at its own initiative or on the request of the European Commission or a member state. The EMA must issue a final report to the Commission within 18 months, which can request financial penalties. The Commission has a further 18 months to issue its statement to the MAH and may request further information from the MAH, the EMA or others before publishing its decision. If it decides that there is an infringement it can order the MAH to cease the infringement and impose financial penalties. This enforcement system works in parallel with national enforcement systems (and so aims to avoid the imposition of double penalties).
9. What is the potential range of penalties for noncompliance?
The MHRA will in the first instance use advice and guidance to achieve compliance, escalating through warning letters and formal cautions, then, in respect of medicines, varying, suspending or revoking authorisations. It typically only brings criminal proceedings as a last resort. If a criminal prosecution is brought, then the penalties depend on whether it is a summary offence (a lesser criminal offence heard before a magistrate with no jury) or an indictable offence (a more serious offence tried before a judge and jury). The maximum penalty on summary conviction under the HMR is a fine not exceeding £5,000 whereas on an indictment conviction the maximum penalties are an unlimited fine and/or imprisonment not exceeding 2 years.
The MHRA’s enforcement powers for noncompliance in relation to medical devices are wide ranging. The Consumer Protection Act 1987 allows it to issue prohibition notices to ban the supply of any goods which fail to comply with the relevant regulations, and it can also file suspension notices and forfeiture orders for non-compliant goods. Further, under the UK MDR, the MHRA can issue compliance notices and/or restriction notices to limit the availability of a particular device or devices of a particular class/description where they are non-conforming (e.g. no CE marking has been applied to them).
If a criminal prosecution is brought, the UK MDR states that for serious offences (such as failing to adhere to a notice) then the possible penalties include 6 months’ imprisonment and/or an unlimited fine.
Where it decides that there is an infringement of authorisation obligations, the European Commission can impose a penalty of up to 5% of the MAH’s EU turnover in the preceding business year, plus a daily penalty of a maximum of 25% of the MAH’s daily EU turnover for the preceding business year if the MAH does not cease infringing when ordered to. Lesser penalties of up to 0.5% of EU turnover apply where the MAH fails to comply with information requests or provides inaccurate or incomplete information.
10. Is there a national healthcare system? If so, how is it administered and funded?
The UK’s NHS is one of the largest publicly funded healthcare services in the world, although since 1999 administration has been devolved to the governments of the UK’s four constituent parts, giving rise to NHS England, NHS Scotland and so on. This answer focuses on NHS England.
The Secretary of State for Health, which is a cabinet position in the UK government, has overall responsibility for the provision of health services in England (as well as other health-related matters that have not been devolved). These responsibilities include financial control and oversight of all NHS England’s services. Below central government level the structure of NHS England is complex and based around Clinical Commissioning Groups (CCGs), which are directly responsible for commissioning hospital and community health services within their local area, and, since 2016, Sustainability and Transformation Partnerships (STPs). STPs are made up of local NHS bodies and local councils with the aim of running services in their area in a more coordinated way and to plan how to improve local residents’ health. STPs can evolve to become “Integrated Care Systems“, which are even closer forms of collaboration between the NHS and local councils with shared responsibility for resourcing and improving local health services.
The NHS is mainly funded from general taxation and National Insurance receipts (National Insurance is a specific tax paid by employers, employees and the self-employed and is used for funding state benefits). In addition, a small portion of NHS England’s funding is generated through patient charges such as those for prescriptions and dental care. NHS England’s budget for 2019/2020 is £121 billion, of which about 80% will come from general taxation.
11. How does the government (or public) healthcare system function with private sector healthcare?
Interactions between the public NHS and private healthcare enterprises are complex and controversial, although private companies and other bodies have always played a role within the NHS. For example, all dentistry and optometry services and pharmacy practices as well as most doctors’ practices are private and certain clinical services (such as radiology and pathology) are delivered through NHS/private enterprise partnerships.
As UK residents are entitled to universal healthcare the private medical insurance (PMI) sector is a niche market. PMI is typically provided as a part of benefit packages for higher-earning employees via monthly premiums. However, many PMI patients still use the NHS for non-emergency and/or routine concerns using the PMI to supplement their care/treatment (e.g. to get appointments with specialist consultants more quickly, for elective procedures or for more complicated health matters).
12. Are prices of drugs and devices regulated and, if so, how?
(i) Branded Medicines
As said in answer to Question 2, the price of branded medicines (prescription and non-prescription and including branded generics) is regulated through either the Voluntary Scheme or the Statutory Scheme.
The Voluntary Scheme arises from an agreement between the DHSC, NHS England, manufacturers and suppliers of branded medicines that have decided to join the scheme and the industry body, the Association of the British Pharmaceutical Industry (ABPI). The Voluntary Scheme has the aims of promoting innovation, public access to cost effective medicines and supporting sustainability of NHS finances. The key terms are that a scheme member wishing to launch a branded medicine on the UK market must give the DHSC at least 28 days’ written notice, with a proposed NHS list price. It cannot proceed with that launch until it has received confirmation that it has freedom of pricing (if the medicine is based on a new active substance) or that its proposed list price is acceptable (taking into account various factors including what the DHSC considers to be a reasonable profit). Even if the scheme member has free pricing, it must still set its price at a level consistent with obtaining a positive appraisal from the National Institute for Health & Care Excellence (NICE – the body that publishes guidance on clinical practice in the NHS). This effectively constrains the price and may require the scheme member to agree discounts with the NHS. Once set, the NHS list price cannot be increased without DHSC approval.
Other terms include, as part of an “affordability mechanism”, that the growth in the total annual cost of branded medicines to the NHS is capped at 2%, with any spending by the NHS over this limit being repaid by the industry (through a percentage payment to be made by each scheme member on their net sales, the percentage being 9.6% for 2019). However, this rebate does not apply to members with sales of scheme products of less than £5 million for the previous year or to sales of medicines based on new chemical entities.
In addition, the Voluntary Scheme places a limit on the reasonable profits that can be made by having a target for the allowable return on capital of 21%, subject to a margin of tolerance of 50%. This means that if a member’s profits exceed the 21% target by over 50%, it either has to repay the excess or reduce prices by an equivalent amount. Conversely, if its profits are more than 50% below the target, it can apply to increase prices.
The small percentage of companies that have not signed up to the Voluntary Scheme are automatically subject to the Statutory Scheme. This controls the maximum price of branded prescription-only medicines (POMs). It also requires companies to pay a percentage of their qualifying annual sales to the government in a similar manner to that under Voluntary Scheme (and, since the Statutory Scheme was introduced the payment percentages have been more closely aligned to those under the Voluntary Scheme). Companies with relevant sales of less than £5m per year are exempt from the price controls and the percentage payments.
(ii) Unbranded Generic Medicines & Medical Devices
See the answer to Question 2 above.
(iii) Over the Counter & Unlicensed Medicines
The price of over the counter (OTC) medicines (i.e. pharmacy-only and general sales list (GSL) medicines) is agreed between the manufacturer or wholesaler and the retailer (pharmacy, supermarket etc.).
Prescribers can prescribe unlicensed medicines except for those on the NHS’s blacklist (Part XVIIIA of the Drug Tariff), which are not permitted. In addition, medicines on the Selected List Scheme (Part XVIIIB of the Drug Tariff) can only be prescribed for the purposes given in the Drug Tariff. Prescriptions must be endorsed “SLS” by the prescriber. The prices in the Drug Tariff are set by analysis of a selection of unlicensed specials manufacturers’ prices, plus a margin for pharmacy purchase profit.
13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?
Essentially, once a price for a licensed, prescription medicine has been set by the mechanisms discussed in the answers to Questions 2 and 12, and so is included in the NHS price list or Drug Tariff, pharmacists or doctors prescribing the medicines will be reimbursed the listed price by the NHS. The same applies to unlicensed medicines, save that prescriptions of blacklisted medicines or Selected List Scheme that are not endorsed “SLS” will not be reimbursed.
In addition, NHS England charges for prescriptions (£9.00 per prescription as from 1 April 2019) whereas NHS Wales, Scotland and Northern Ireland do not. However, prescriptions in England are free for a number of categories of persons including: children under 16, low income support individuals, pregnant women, persons over the age of 60 and other groups of individuals with valid medical exemptions. There is also the option of the Prescription Prepayment Certificate (PPC) for those who do not qualify for free prescriptions. The PPC entails a fixed amount payment for a 3 month or 12 month period irrespective of the number of prescriptions needed. It therefore provides a cost effective method of meeting prescription charges for those who need more than 1 prescription per month.
The above applies to primary care. As regards secondary care (e.g. within hospitals, clinics or similar), the NHS uses a payment by results model for reimbursement of the care provider, based on factors such as number of patients treated, the length of the patients’ stays and the nature and complexity of the treatment. The price of the medicines involved is not directly taken into account.
(ii) Medical Devices
Once a medical device has been CE marked, and approved by NICE, it can be listed in the British National Formulary (BNF). For reimbursement, though, CCGs need to decide to allow use of the device in hospitals and/or out of hospital in their region. Once a CCG decides that a BNF-listed device should be available, the NHS can reimburse its use.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
The Medicines Act 1968 defines 3 legal categories of medicines: POMs, pharmacy medicines and GSL medicines.
POMs can only be sold by a pharmacy registered with the General Pharmaceutical Council (GPhC), under the supervision of a responsible pharmacist, and pursuant to a valid prescription given by an authorised practitioner (these requirements apply even when the sale or supply is made via the internet). The responsibilities of the responsible pharmacist are set out in the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 (discussed further in answer to Question 15) and he/she must be registered with the GPhC. A corporate body running a registered pharmacy or pharmacies must also nominate a registered pharmacist to act as superintendent pharmacist with overall management of the pharmacy. The responsible and superintendent pharmacist can be the same person (though where a company runs several pharmacies, it will not be possible for one person to meet both sets of legal duties).
The same rules apply to the sale and supply of pharmacy medicines (save that they are not sold pursuant to prescriptions).
GSL medicines can be sold from any premises so long as they are pre-packed and the premise can be locked from the public (and, if sold from a machine, that machine must be within such premises).
The reimbursement of pharmacies for drugs and devices supplied by them has been discussed in the answers to Questions 2 and 13. In addition, pharmacies can claim certain fees and allowances from NHS England for dispensing certain products under Part IIIA of the Drug Tariff (which covers professional fees).
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
As said in answer to Question 14, a pharmacy business must appoint a registered pharmacist to act as the responsible pharmacist. The responsible pharmacist’s role is to secure the safe and effective running of the registered pharmacy at all times that he/she is in charge (i.e. including when the pharmacy is operating but not open to the public or when absent on pharmacy business). In particular, the role includes responsibility for the sale and supply of all medicines from the pharmacy. The duties include:
- displaying a conspicuous notice that gives the details of who the responsible pharmacist is;
- making and keeping records;
- following pharmacy procedures; and
- making appropriate arrangements for periods when absent from the pharmacy.