Promotion
Regulation
Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?
Medicinal products
The advertising of medicinal products in the United Kingdom is controlled by a combination of legislation and industry codes of practice. The relevant legal framework is set out in the Human Medicines Regulations 2012 (HMRs); the changes to the HMRs as a result of Brexit have not affected the advertising of medicinal products and the rules applicable in the UK are currently consistent with the provisions of Directive 2001/83/EC. While, therefore, in accordance with the Northern Ireland Protocol, regulation of medicines in Northern Ireland continues to be subject to EU law, the rules governing advertising of medicinal products in Great Britain and Northern Ireland are currently aligned. The general provisions of the Bribery Act 2010 are also applicable in the context of advertising of medicinal products. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for supervision of advertising and issues guidance, mainly through the ‘Blue Guide: Advertising and Promotion of Medicines in the UK’, which was updated at the end of 2020. In addition to the legal requirements, most pharmaceutical companies operating in the UK agree to self-regulation in accordance with the relevant industry codes of practice. These mainly include the Association of the British Pharmaceutical Industry (ABPI) Code updated in July 2021 (administered by the Prescriptions Medicines Code of Practice Authority (PMPCA)) and the Proprietary Association of Great Britain (PAGB) Code, which regulate the advertising of prescription-only and over-the-counter medicines respectively. Both Codes reflect and, in certain respects, extend beyond the legal requirements.
UK law and the self-regulatory codes provide rules for advertising of medicines to the public and advertising aimed at HCPs. Advertising to the public is permitted for medicines that are not legally classified as prescription only, while advertising of prescription-only medicines may only be targeted at ‘persons qualified to prescribe or supply medicines’. Advertising of unauthorised medicines or indications is not permitted. All medicines advertising must be consistent with the approved summary of product characteristics. Furthermore, where a product is only authorised in part of the UK (Great Britain or Northern Ireland), it may only be advertised in the territory where it is authorised. UK-wide advertising of a product is permissible only where the product is authorised in both Great Britain and Northern Ireland.
Under the HMRs, advertisement is defined broadly as ‘anything designed to promote the prescription, supply, sale or use of a medicinal product’. This is stated to include: ‘door-to-door canvassing, visits by medical sales representatives to persons qualified to prescribe or supply medicinal products; the supply of samples; the provision of inducements to prescribe or supply medicinal products by gift, offer or promise of any benefits or bonus, whether in money or in kind (except where the intrinsic value is minimal); the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including payment of expenses’.
Corporate or financial information describing a company’s area of business, including progress in research will likely fall outside this definition, provided it includes no product claims and is directed towards an appropriate audience.
Online advertising is subject to the same provisions and controls as traditional advertising, although the ABPI and PAGB Codes include provisions specifically directed towards advertising through the internet and the use of online platforms and social media. The PMCPA has published guidance on digital communications, which includes advice on how companies can use digital communication tools such as Twitter, Facebook, Pinterest and Wikipedia, whilst complying with the restrictions under the ABPI Code. In addition, the new 2021 ABPI Code has been updated throughout to address digital communications. The MHRA’s Blue Guide also contains information relevant to this, and confirms that material posted on UK websites (including social networking sites, blogs and discussion forums) and/or aimed at a UK audience is subject to UK medicines advertising legislation.
Medical devices
Legislation concerning medical devices is principally provided by the Medicines and Medical Devices Act 2021 and the Medical Devices Regulations 2002. These contain few provisions relating to the advertising of medical devices, save to provide that a device must be covered by an appropriate marking as required in the relevant part of the UK before it may be advertised to any audience. Advertising of medical devices is also subject to the general laws relating to consumer products advertising including the Consumer Protection from Unfair Trading Regulations 2008 (business-to-consumer practices) and the Business Protection from Misleading Marketing Regulations 2008 (business-to-business practices).
In accordance with the Northern Ireland Protocol, the EU Medical Devices Regulation 2017 (EU MDR) is also applicable in Northern Ireland. Advertising of medical devices in Northern Ireland is therefore subject to the EU MDR prohibition on the use of misleading claims in the advertising of medical devices.
The Advertising Standards Authority (ASA) is the UK’s independent regulator for general advertising across all media. The Committee of Advertising Practice (CAP) is the body responsible for writing and maintaining the CAP Codes. The CAP Codes apply to advertising of products to consumers but not to advertising addressed solely to HCPs and provide specific rules controlling advertisements of medical devices. They cover all media including all electronic media, online and other media, but there are no longer specific rules for distance selling.
From a self-regulation perspective, the Association of British HealthTech Industries (ABHI) Code of Ethical Business Practice sets out the minimum standards that should apply to members’ UK business practices in connection with promotion addressed solely or primarily to HCPs. The ABHI Code implements the provisions of the MedTech Europe Code of Business Practice and regulates various activities, including interactions with HCPs, advertising and promotion, unlawful payments and practices, data privacy, and compliance and enforcement. The requirements of the ABHI Code apply to advertisements in electronic media, including, but not limited to, online advertisements.
In addition, the PAGB (which represents UK manufacturers of self-care medical devices) issued a new Medical Devices Consumer Code of Practice for advertising of self-care medical devices products for PAGB members in 2019. The PAGB defines self-care medical devices as those that treat or prevent self-treatable conditions.
Inducement
What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?
Medicinal products
The HMRs prohibit the supply, offer or promise of gifts, pecuniary advantages or other benefits to HCPs in connection with the promotion of medicinal products unless they are inexpensive and relevant to the practice of medicine or pharmacy. These provisions apply to advertising, price promotions, loyalty schemes and bonus schemes. Inexpensive items are considered to be those which do not cost a company more than £6 (excluding VAT) and represent a similar value to the recipient; while the criterion of ‘relevance’ is only met by items that have a clear business use. The prohibition of inducements explicitly excludes measures or trade practices relating to prices, margins or discounts that were in existence on 1 January 1993. Hospitality to HCPs is considered acceptable in the context of events for professional or scientific purposes provided this is limited to the main purpose of the event and offered to HCPs and appropriate administrative staff only. The general provisions of the Bribery Act are also applicable.
The ABPI Code goes further than the HMRs in prohibiting the supply, offer or promise of any gift, pecuniary advantage or benefit to members of the health professions or to other relevant decision-makers in connection with the promotion of medicines or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. Promotional aids are no longer permitted save for inexpensive notebooks, pens and pencils for use at company organised meetings. Such items must not bear the name of any medicine or provide any information about medicines, but may bear the name of the company providing them. No individual attendee should receive more than one pen or pencil or one notepad. HCPs may be provided with items that are to be passed on to patients in accordance with the conditions contained in the ABPI Code.
These restrictions do not prevent the provision of educational or promotional material to HCPs or other relevant decision makers in the form of inexpensive memory sticks and the like. In appropriate circumstances, independently produced medical or educational publications, such as textbooks may be given to healthcare organisations as a grant or a donation; they must not be given to individuals.
Medical devices
The Medical Devices Regulations 2002 do not address the question of inducements offered to HCPs to prescribe sell, supply or recommend use of a particular medical device or to offer the relevant device company any other benefit. Such activities are however prohibited as a result of the Bribery Act 2010.
The EU MDR, which is applicable in Northern Ireland, prohibits the offer of inducements that might influence the judgment of conformity assessment bodies. This requirement is also reflected in the Guidelines on the appointment of UK Conformity Assessment Bodies certifying for the GB and NI market from 1 January 2021, issued by the Department for Business, Energy and Industrial Strategy.
From a self-regulation perspective, the ABHI Code, in line with the European MedTech Code, prohibits member companies from providing financial or in-kind support directly to individual HCPs to cover costs of their attendance at third-party organised educational events with the exception of procedure training meetings or pursuant to a consulting agreement with a speaker for a satellite symposium. It also sets out clearer transparency obligations with regard to all interactions with HCPs, in terms of notifications to the relevant health institutions before the interaction may take place.
Reporting transfers of value
What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?
Medicinal products
UK law does not require the recording or publishing of the details of transfers of value (ToV) made directly or indirectly to HCPs and, other relevant decision makers, healthcare organisations (HCOs), patient organisations or others by pharmaceutical companies. These requirements are imposed by the self-regulatory Codes.
The ABPI Code has implemented the EFPIA Code requirements for disclosure of ToV to HCPs, HCOs and other relevant decision makers on an annual basis. It defines a ToV as ‘a direct or indirect transfer of value, whether in cash, in-kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development or sale of medicines.’ The Code requires companies to document and publicly disclose ToV on an annual basis, relating to collaborative working, donations and grants, contractual services, sponsorship of attendance by HCPs at meetings, fees and expenses paid to HCPs, and contributions made towards the costs of meetings paid to HCOs. Where ToV have been made to individual HCPs, the disclosure should identify the HCPs concerned (unless precluded by legal reasons). Where individual HCPs may not be identified, ToV should be disclosed on an aggregated basis.
The ABPI Code also requires member companies to disclose ToV to POs and also to disclose contracted services provided by members of the public, including patients and journalists.
Companies making ToV must publish a note summarising the methodologies used in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of the Code.
The provisions and requirements are summarised in the European Union chapter.
Medical devices
There are no legal requirements for medical device companies to disclose payments to HCPs, HCOs, POs or others.
However, under the ABHI Code, member companies are required to document and publicly disclose all educational grants provided to HCOs based or registered in Europe. ToV not related to educational grants are not within the scope of the disclosure obligation.
Educational grants shall be disclosed on an aggregate basis for each recipient for the reporting period (annually, each calendar year). Itemised disclosure must be made available upon request by the relevant recipient or the relevant authorities, or both. ‘Educational grants’ means those grants made to support third-party organised events (including support for HCP participation at the event) and other educational grants made to HCOs (including scholarships, fellowships and grants for public awareness campaigns).
Disclosure shall be made within six months of the end of the relevant reporting period and will be made public on 31 August of the year of the relevant time of disclosure. Disclosure should be made in English using the template set forth in the Annex to the ABHI Code.
Enforcement of advertising rules
Enforcers
Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
Medicinal products
The Human Medicines Regulations 2012 (HMRs) provide a means of enforcement and include both criminal and civil sanctions. The HMRs provide that it is an offence for ‘any person’ to breach the Regulations. This allows enforcement action to be taken against all stakeholders involved in the promotion, including marketing authorisation holders, publishers and advertising agencies.
Enforcement of the advertising provisions of the HMRs is the responsibility of the Enforcement Group of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA prefers to resolve complaints quickly and informally, with companies agreeing to take voluntary action to amend their advertising and, in some cases, to issue a corrective statement. Details of cases resolved informally are posted on the MHRA’s website.
Complaints under the Association of British Pharmaceutical Industries (ABPI) Code are considered by the Prescriptions Medicines Code of Practice Authority (PMPCA) Code of Practice Panel.
The two systems, statutory and self-regulatory, are regarded as ‘complementary and synergistic’ (memorandum of understanding between the MHRA, ABPI and PMCPA). Both bodies may hear complaints from any source, but the MHRA generally refers inter-company complaints to the PMCPA and routinely declines to investigate cases where it is aware that these are under investigation by a self-regulatory body. The Serious Fraud Office (SFO) is responsible for enforcement of alleged examples of bribery and corruption but will generally intervene in matters concerning advertising of medicinal products only where it considers that the self-regulatory regime is not effective or the potential sanctions that may be imposed are inadequate (memorandum of understanding between the SFO, ABPI and PMCPA).
Medical devices
The MHRA’s enforcement powers in relation to medical devices derive principally from the Medical Devices Regulations 2002 and general powers that are not specific to devices. In addition, the Medicines and Medical Devices Act 2021 seeks to consolidate and expand the enforcement regime for medical devices, so that enforcement provisions and powers are contained solely in the 2021 Act.
Under these provisions, the MHRA can investigate any business activity that is covered by the regulations and is empowered to assess allegations of non-compliance, to monitor the activity of Notified or Approved Bodies and to investigate medical devices as a result of adverse incident reports.
Under the self-regulatory system, compliance with the ABHI Code is mandatory for ABHI members and those who have accepted the jurisdiction of the ABHI Complaints Adjudication Panel. The Code is administered by the ABHI Secretariat in conjunction with the chair of the Panel. The Panel is not an investigatory body and the complainants have the burden of proving their complaint. The Panel is responsible for resolving complaints made under the Code and may also assist in arranging for conciliation or mediation between companies. There is no appeal procedure against the Panel’s rulings; however, this procedure does not preclude recourse to courts or other tribunals.
Sanctions
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
Medicinal products
The MHRA has the power to issue notices prohibiting the publication of specific advertisements. Where the MHRA notifies a company that it considers an advertisement to be in breach of the HMRs, the company has the right to make representations to the MHRA Review Panel. If the MHRA issues a final notice determining that an advertisement is in breach, the company has no further right to appeal and will commit a criminal offence if it proceeds to publish the advertisement. The company may also be asked to issue a corrective statement. Companies may challenge the legality of the MHRA final notice by judicial review.
A person or company that contravenes the legislation may be subject to an unlimited fine. In addition, or alternatively, where individuals are involved in the publication or use of unlawful advertising, a period of up to two years’ imprisonment may be imposed. Where directors are convicted of a criminal offence, they may also be disqualified. Fines are imposed according to the offence in question.
While there are only a few precedent decisions concerning the level of fines imposed, it is clear that the fine may be a substantial amount that is calculated to send a message to the defendant’s shareholders (in cases where the defendant is a company rather than an individual). Fines must be paid directly by the person or company convicted, and cannot be insured. In addition, the MHRA’s costs in bringing the proceedings are typically borne by the defendant, if convicted.
When a company is found in breach of the ABPI Code, an administrative charge is imposed: £3,500 per matter for ABPI member companies, and £12,000 if the matter is unsuccessfully appealed. The charges increase to £4,500 and £13,000 respectively for non-members. In addition, the Panel and the Appeal Board have the power, in serious cases, to require an audit of the company’s promotional procedures or to refer the matter to the ABPI Board of Management, which may suspend or expel the company from the ABPI, with the result that the company becomes subject to direct supervision by the MHRA.
The PAGB does not impose any financial sanctions but it may expel a company if it has failed to comply with the PAGB Code.
Medical devices
Upon completion of an investigation, the MHRA may impose a range of sanctions, including the issuance of a warning letter or a formal caution. The enforcement options include prohibition, suspension, compliance and restriction notices.
At present, most offences under the medical devices legislation are summary offences, meaning that penalties are generally lower than those that may apply to offences relating to medicines. The ABHI operates a similar enforcement system to that of the ABPI and the PMCPA, whereby member companies may ultimately be expelled from the ABHI. However, the Medicines and Medical Devices Act 2021 provides the Secretary of State with the ability to impose civil sanctions as an alternative to criminal prosecution and seeks to create a bespoke criminal offence that clarifies which contraventions of the Medical Devices Regulations 2002 could result in prosecutions. In particular, the Act provides the Secretary of State with powers to impose a monetary penalty on a person (where the Secretary of State is satisfied beyond reasonable doubt that the person has committed an offence) and accept an enforcement undertaking (where the Secretary of State has reasonable grounds to suspect a person has committed an offence and that person offers the undertaking).
Pricing and reimbursement
Pricing
What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
Medicinal productsPricing
The UK National Health Service Act 2006 provides the statutory basis for controlling the prices of health service medicines.
The prices of branded health service medicines (originator products, branded generics and biosimilars) are controlled under the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) or the parallel Statutory Scheme. In addition to these measures, the prices of medicines are controlled through public procurement procedures and limitations on reimbursement.
VPAS
The VPAS is a voluntary scheme, not binding under the laws of contract, negotiated between the Department of Health and Social Care and the Association of the British Pharmaceutical Industry.
The VPAS controls the prices of branded medicines indirectly, by limiting the profits that may be made by manufacturers and suppliers on such products on their National Health Service (NHS) business, by reference to a target rate of return on NHS sales, based either on total sales or capital. A margin of tolerance (MOT) of 50 per cent is permitted around the target level of profit. However, if a company exceeds the profit limit by more than the MOT, it will be required to do one or more of the following:
- repay excess profits over and above the MOT;
- reduce prices charged to the NHS to bring profits down to an acceptable level based on available forecasts; or
- delay or restrict agreed price increases.
The VPAS also imposes a budget cap on total expenditure on branded medicines by the NHS, with scheme members required to make scheme payments to the Department of Health and Social Care (calculated as a percentage of eligible net sales) in respect of excess expenditure. The payment percentage for 2019 was set at 9.6 per cent, for 2020 at 5.9 per cent and for 2021 at 6.6 per cent.
New branded health service medicines introduced by VPAS member companies following the grant of an EU or UK new active substance marketing authorisation are generally subject to free pricing, as are new products based on the same active substance that are line extensions, launched within 36 months of authorisation of the initial indication in the United Kingdom. The Department of Health and Social Care must be notified of the proposed price prior to launch and will confirm whether the product may be priced freely. The maximum price or NHS List Price of new branded health service medicines supplied by VPAS member companies that do not contain a new active substance must be approved by the Department of Health and Social Care prior to launch.
No VPAS member may increase the NHS List Price of a relevant medicinal product without the Department of Health and Social Care’s prior approval. Where a company wishes to increase the price, it should provide at least eight weeks’ notice, stating the amount of the proposed increase and the reasons in sufficient detail to satisfy the Department that the increase is justified. A price increase will only be agreed if the scheme member’s estimated and forecast profits for the current and following financial years are below 50 per cent of the target level. No scheme member will be awarded a price increase within 12 months of a previous agreed increase.
Statutory Scheme
If a company that supplies branded medicines to the NHS is not a member of the VPAS (around 10 per cent of such companies), it is regulated by the parallel Statutory Scheme, currently set out in the Branded Health Service Medicines (Costs) Regulations 2018. The Statutory Scheme is applicable only to branded health service prescription-only medicines. Since 1 April 2018, it has involved a payment scheme, calculated as a percentage of net sales, similar to the scheme payments required under the VPAS. Payments are made on a quarterly basis, and the payment percentage was 9.9 per cent in 2019, 7.4 per cent in 2020 and 10.9 per cent in 2021.
The maximum or NHS List Price of new branded medicines supplied by Statutory Scheme members is directed by the Secretary of State, taking into account factors similar to those under the VPAS, including whether the product includes a new active substance.
A Statutory Scheme member company may apply to the Secretary of State to increase the maximum price of a medicine. Any such application by a manufacturer or supplier must be in writing and must specify the presentations to which it relates, the reasons justifying the increase and the proposed new price.
There is no formal system of international reference pricing in the UK, although the cost of the presentation in other markets is specifically mentioned as a factor for consideration under both the VPAS and the Statutory Scheme.
Unbranded generic medicines
Unbranded generic medicines may be priced at the discretion of the manufacturer, with the expectation that prices will be controlled by competition. Where the price charged for a specific unbranded medicine is viewed as excessive, the Secretary of State has power under the National Health Service Act 2006 to issue a specific direction in relation to the price of that product.
Reimbursement
There is no formal reimbursement step or ‘decision’ that has to be undertaken in the UK. Once the price of a medicine has been notified to or agreed by the Department of Health and Social Care, the product is, in principle, available to be prescribed and reimbursed, unless it is listed in Schedules 1 or 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) Regulations 2004, which provide that certain medicines may not be prescribed using NHS prescriptions and others may be prescribed only for certain conditions (the ‘black’ and ‘grey’ lists). In practice, however, reimbursement is controlled through local formularies and national commissioning policies.
In England, most new medicines (and new indications for existing products) undergo health technology appraisal or highly specialised technology evaluation by the National Institute for Health and Care Excellence (NICE), which assesses their clinical effectiveness and cost effectiveness compared with standard care in the UK, and issues guidance to the NHS on use of the new product or indication. NHS bodies in England have a legal obligation to make funding available for treatments recommended by NICE following such assessments, usually within three months of guidance being published. NHS England conducts a prioritisation assessment that determines which specialised services (medicines, medical devices and other health interventions), which have not been assessed by NICE, will be funded on an annual basis. Other medicines, which are not specialised services and have not been assessed by NICE, undergo assessments at local level. Similar assessments to those carried out by NICE are undertaken by designated bodies in Scotland and Wales. Medicines that have not been recommended following an appropriate assessment are unlikely to be routinely available for patient treatment.
Medicines supplied in hospitals are not subject to any co-payment arrangements. However, for products supplied in primary care in England, patients must pay a fixed price for each NHS prescription dispensed, unless they fall within one of the exempt categories (eg, children, the elderly and persons suffering from certain chronic diseases) or the prescription is exempt (eg, certain contraceptives). The overwhelming majority of prescriptions are dispensed free of charge to persons in an exempt category. The current prescription charge is set at £9.15, which, in some cases, exceeds the price of the medicine dispensed. Prescription charges are not levied in Scotland, Wales or Northern Ireland.
Community pharmacies purchase medicinal products from wholesale distributors or directly from manufacturers. They are reimbursed by the NHS Business Services Authority for the products they dispense in the course of providing pharmaceutical services for the NHS, in accordance with the amounts set out in the Drug Tariff, published monthly in England in accordance with the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013/349. Similar regulations provide for equivalent drug tariffs in Scotland and Northern Ireland. Where medicinal products are not listed in the Drug Tariff (most medicines that are still subject to patent protection) or are prescribed by brand, the pharmacy contractor will generally be reimbursed at the manufacturer’s NHS List Price.
Medical devicesPricing
Medical devices and in vitro diagnostic tests may be priced at the discretion of the manufacturer. However, as with medicines, prices may be controlled through public procurement procedures and control of reimbursement.
Reimbursement
The reimbursement of a medical device depends on the context in which it is used. Many medical devices used in hospitals are reimbursed under tariff systems where the price paid to the hospital by the relevant clinical commissioning group for the overall treatment includes the cost of the device, which may in turn be purchased under public procurement tenders. Certain high-cost medical devices are, however, paid for separately outside the tariff system.
Medical devices may undergo health technology assessment under one of NICE’s parallel programmes, either on the application of the manufacturer or following referral by NHS bodies or clinicians. These will all involve assessment of the clinical use of the medical device and some will also include consideration of economic evidence. In general, the content of NICE’s recommendations and briefings on use of medical devices is advisory only, although intended to avoid the need for repetitive assessment at local level. However, a NICE recommendation for use of a medical device following technology appraisal carries with it the requirement for NHS bodies to provide funding for the device to be available as an option for patients, as described above.
Alternatively, medical devices used in specialised services may be assessed by NHS England under its prioritisation procedure, involving consideration of both benefits and costs and comparison with a range of other health technologies, to determine which should be prioritised for NHS commissioning. In some cases, where the clinical data are viewed as inadequate to reach a conclusion on NHS use, a commissioning through evaluation approach is adopted, where use of the device in a limited number of patients over a specified period of time (usually two years) is funded by the NHS and data are collected for the purposes of a final commissioning decision at the conclusion of the process. High-cost medical devices may be purchased through NHS Supply Chain, which negotiates with manufacturers on behalf of all NHS purchasers collectively.
In primary care, medical devices, such as appliances and dressings, incontinence appliances, stoma appliances and chemical reagents, are routinely dispensed through the NHS if a reimbursement price, agreed with the NHS Business Services Authority, is listed in the Drug Tariff. The reimbursement price is principally determined by comparing the device with the prices of similar products on the market. If there are no comparable devices or the applicant submits evidence to support a different price, the reimbursement price will be determined by negotiation between the parties. Applications must meet three criteria, supported by evidence: the products are safe and of good quality (generally assumed for all CE-marked products); they are appropriate for general practitioners and, if relevant, non-medical prescribing; and they are cost effective (eg, as determined by NICE).
Sale and supply
Regulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
Medicinal products
All medicinal products marketed in the UK are classified according to one of the three following categories:
- prescription-only medicines, which are available only by prescription from a doctor or other authorised health professional, and must be dispensed from a pharmacy or other specifically licensed premises;
- pharmacy or over-the-counter medicines, which are only available in pharmacies under the supervision of a pharmacist; and
- general sale list (GSL) medicines, which are available in general retail outlets, such as supermarkets.
The classification of a medicinal product is determined by its marketing authorisation and determines the level of control over how it is supplied. In part, classification rests on how much input from healthcare professionals is needed to diagnose and treat the conditions for which the medicine might be used. The underlying principle for classification is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use.
Medical devices
There are three main types of medical devices:
- general medical devices;
- active implantable medical devices; and
- in vitro diagnostic medical device (IVD).
Medical devices are also given a classification depending on the level of risk associated with their use. Classification depends on factors such as intended purpose, duration of use and whether it is invasive or surgically invasive, implantable or active, or contains a medicinal product.
The categories for general medical devices and active implantable devices are Class I (low risk), Classes IIa and IIb (medium risk) and Class III (high risk). All active implantable medical devices fall under the highest risk category.
IVDs are categorised into four main groups based on whether they are general IVD medical devices, intended for self-testing, or classified under Lists A or B in Part IV of the UK Medical Device Regulations 2002.
All medical devices placed on the market in Great Britain must be registered with the MHRA. A UK Approved Body ensures manufacturers have followed the appropriate conformity assessment route and comply with the UK regulations, including reviewing clinical and scientific data, manufacturing processes and the quality management system. If they comply then the UK Approved body will issue a UKCA certificate, which manufacturers can place on their device to show that it has passed the conformity assessment.
Online supply
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
Online retailers may only sell GSL products unless they are registered pharmacies. With regard to medical devices, the MHRA advises buyers to look for the UKCA mark on medical devices as an indicator that they have been approved to be placed on the market in Great Britain. Online pharmacies and clinics are regulated by bodies such as the General Pharmaceutical Council and the Care Quality Commission.
The online supply of both medicines and medical devices must also comply with the Electronic Commerce (EC Directive) Regulations 2002 (as amended by the corresponding Brexit statutory instrument).
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