Trends and developments
Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?
Notable trends include the following:
- The European Medicines Agency (EMA) will relocate from London to Amsterdam and will be operational by 30 March 2019 – a consequence of Brexit. The full impact of Brexit on the sector is unknown, but assuming that the United Kingdom is treated as a third party, pharmaceutical companies and others in the supply chain face significant regulatory changes and costs.
- On 25 May 2018 the General Data Protection Regulation (2016/679/EC) came into force. One of the most pertinent changes is a new definition of ‘consent’, which must be informed, freely given and specific; this specificity requirement may inhibit secondary uses of clinical data which is often repurposed in the pharmaceutical industry for purposes for which individuals may not have provided their specific consent.
- The Clinical Trial Regulation (536/2014/EC) comes into force in 2019. The regulation harmonises the assessment and supervision procedures for EU clinical trials, via an EU portal and a database operated by the EMA.
- Pursuant to the EU Falsified Medicines Directive, from 9 February 2019 packs of prescription-only medicines must carry an active unique identifier, which allows repeated verification of the authenticity of each pack.
- There is a growing trend in the use of artificial intelligence in drug discovery, clinical trials and disease diagnostics, as well as Big Data, real world evidence and health data analytics. These trends are disrupting the traditional pharma industry and new entrants from the technology sector are emerging.
What is the primary legislation governing medicinal products in your jurisdiction?
The key UK legislation for authorising medicines derives from EU legislation – in particular:
- Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) (Code for Human Medicines Directive); and
- Regulation (EC) 726/2004 on the authorisation and supervision of medicines and establishing a European Medicines Agency (as amended).
The Human Medicines Regulations 2012 implement the EU legislation above and matters of national competence (eg, the supply of unlicensed medicines). The regulatory pricing regime for medicinal products is contained in the National Health Service Act 2006 and the Health and Social Care Act 2012, together with subordinate legislation.
Are any legislative changes proposed or expected in the near future?
The EU Regulations on Medical Devices (2017/745) and on In Vitro Diagnostic Medical Devices (2017/746) entered into force on 25 May 2017. These regulations will fully apply in EU member states from 26 May 2020 and 2022, respectively.
On 8 June 2016 the European Union adopted the EU Trade Secrets Directive. EU countries had to bring into force national laws to comply with the directive by 9 June 2018.
Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?
The UK national competent authority for both medicinal products and medical devices is the Medicines and Healthcare products Regulatory Agency (MHRA), which is an executive agency of the Department of Health. The department also oversees the pricing and reimbursement of medicines used in the National Health Service, with input from health technology assessment bodies, such as the National Institute for Health and Care Excellence.
The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for EU-wide marketing authorisations for medicinal products. These are granted by the European Commission, based on the EMA’s opinion.
A number of non-governmental bodies are involved in regulating advertising and promoting medicines and medical devices (eg, the Advertising Standards Authority) and various industry associations (eg, the Association of the British Pharmaceutical Industry, the Prescription Medicines Code of Practice Authority and the Association of British Healthcare Industries).
Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?
Yes – competition, international trade, data protection and consumer protection are critical to the pharmaceutical sector. Further, the laws protecting IP rights and compliance are key.
Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?
Traditional herbal medicines and homeopathic medicines are regulated as medicinal products, although herbal medicines are subject to traditional herbal registration (THR). A THR is granted only if the medicine is used for minor health conditions where medical supervision and a marketing authorisation are not required. Supplements (eg, vitamins and minerals) which neither have nor are presented as having a medicinal effect are regulated as food supplements under food legislation.
What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?
A Medicines and Healthcare products Regulatory Agency (MHRA) issued manufacturer licence is required to manufacture, assemble or import medicinal products.
To be granted a manufacturer licence, a manufacturer must demonstrate that it complies with EU good manufacturing practice requirements. It must also pass regular good manufacturing practice site inspections by the MHRA.
What is the fee for obtaining authorisation?
The fees for obtaining manufacturer and wholesale distribution licences are set out in the Medicines (Products for Human Use) (Fees) Regulations 2013 and are listed on the MHRA's website.
What is the validity period for authorisation?
Manufacturer and wholesale distribution licences remain in force until they are:
- revoked by the MHRA; or
- surrendered by the licence holder.
How robust are the standard good manufacturing practices followed in your jurisdiction?
Very robust. The MHRA publishes data annually on any deficiencies and identifies trends – in 2016, for example:
- 1,428 inspections were carried out;
- 148 inspections were selected for the sample and 22% had a major deficiency under the ‘quality systems’ category; and
- only 10 new referrals were made to the Inspection Action Group (IAG).
What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?
Failure to comply with the terms of a manufacturing licence can result in a criminal offence, the penalties for which are a fine not subject to any statutory maximum or, if dealt with on indictment, up to two years' imprisonment.
The MHRA carries out inspections to check whether manufacturing and distribution sites comply with good manufacturing practice. If the inspector finds critical deficiencies or discovers that agreed action plans from previous inspection deficiencies remain unresolved, they will contact the IAG. Enforcement actions include:
- refusing to grant or revoking a licence;
- suspending a licence for a stated period;
- proposing to vary a licence;
- removing a qualified person or responsible person from a licence;
- issuing a warning letter;
- increasing inspection frequencies;
- scheduling mandatory meetings at the MHRA;
- referring to the MHRA Enforcement Group for further consideration;
- issuing good manufacturing practice non-compliance statements; and
- adding conditions to good manufacturing practice certificates.
How are the distribution and storage of medicinal products regulated?
The MHRA and the European Medicines Agency (EMA) have published guidance on good distribution practice. Good distribution practice requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the marketing authorisation and product specifications. The MHRA monitors safety and quality standards by regular inspections of good and safe practices, including medicine distribution and storage.
Import and export
How are the import and export of medicinal products regulated?
An MHRA-issued manufacturer licence is required to import medicinal products. A person exporting a medicinal product outside the European Economic Area must have a manufacturer or wholesale distribution licence. Exporting unlicensed medicinal products (known as ‘specials’) outside the European Economic Area is prohibited. Further, the destination country may require an export certificate, which can be obtained from the MHRA.
Are parallel imports permitted in your jurisdiction?
The MHRA parallel import licensing scheme allows a medicinal product authorised in another EEA country to be imported into the United Kingdom if the imported product has no therapeutic difference from an equivalent product already authorised in the United Kingdom. The parallel importer must:
- ensure that the product was manufactured according to good manufacturing practice;
- hold an MHRA wholesale distribution authorisation; and
- hold the correct type of MHRA parallel import licence.
Sale and purchase
What rules govern the dispensing, sale and purchase of medicinal products?
To place a medicinal product on the UK market, the product must have a valid marketing authorisation, obtained either from the EMA (centralised procedure) or by making a national application to the MHRA.
Medicinal products with valid market authorisations can also be sold or supplied by a person holding a wholesale distribution authorisation. A person holding a manufacturer licence may sell the product only to the marketing authorisation holder.
Medicines fall under one of the following categories:
- prescription only;
- pharmacy only; and
- general sale list.
Prescription-only medicines can be dispensed to consumers only if certain conditions are satisfied.
Are there any restrictions on the online sale and purchase of medicinal products?
Online sellers of medicines to the general public (if established in the United Kingdom) must be on the MHRA’s list of UK registered online retail sellers and display the EU common logo – which verifies the seller’s registration – on every web page that offers medicines for sale. The EU common logo is now a legal requirement across all EU member states. Selling medicines online without being registered and displaying the logo is illegal and may result in prosecution.
Named patient supply
What rules govern named patient supply of pre-launch medicinal products?
Named patient supply is an exception to the requirement for a medicinal product to have a marketing authorisation. Patients can be prescribed and supplied with products which are not licensed in the United Kingdom if the conditions set out in Part 10 of the Human Medicines Regulations 2012 are met.
The MHRA also operates an early access scheme for products treating, diagnosing or preventing life-threatening, chronic or seriously debilitating conditions with a high unmet need.
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Authorisation applicants must be sponsors of the trial or its legal representative (if the sponsor is not established in the European Union). Submissions must be made to the Medicines and Healthcare products Regulatory Agency (MHRA).
Sponsors must have a positive opinion from an ethics committee before the start of the trial, which can be obtained at the same time or after submission to the MHRA.
Clinical trials have four phases and a product can pass to the next phase only if it has passed the safety and effectiveness tests of the previous phase.
Following the submission of a valid request, the MHRA conducts an initial assessment within 30 days (on average within 14 days for a Phase I trial) and either:
- accepts the request for the clinical trial authorisation;
- accepts the request subject to conditions (eg, the sponsor can submit an amended request within 14 days and the MHRA will assess within 60 days of the original request); or
- denies the request and provides reasons for its decision.
How robust are the standard good clinical practices followed in your jurisdiction?
Very robust. The United Kingdom adheres to a set of internationally recognised good clinical practice requirements that must be followed when designing, conducting, recording and reporting clinical trials. To ensure good clinical practice compliance, the MHRA carries out inspections and must be notified if serious breaches of good clinical practice or the trial protocol are uncovered.
If critical findings are identified, these are referred to the Good Clinical Practice Inspection Action Group (IAG) – a cross-agency group that oversees all critical findings and decides on the actions to be taken, in addition to reviewing the corrective and preventative action report for the critical finding.
The IAG may consider a number of possible non-routine post-inspection actions depending on the critical finding and its impact on public safety and data integrity, including:
- quarterly reporting;
- early re-inspections;
- referrals to relevant stakeholders (eg, other regulators or agencies, the Health Research Authority (HRA), the General Medical Council or the Care Quality Commission;
- suspending calls to action;
- serving infringement notices; or
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
All UK relevant suspected unexpected serious adverse reactions (SUSARs) which occur during a trial must be reported to the MHRA. Fatal or life-threatening SUSARs must be reported as soon as possible, but no later than seven days after becoming aware of the reaction. Any additional relevant information must be sent within eight days of the report. Non-fatal or non-life-threatening SUSARs must also be reported as soon as possible, but no later than 15 days after first becoming aware of the reaction.
The MHRA’s definition of ‘UK relevant’ includes SUSARs originating in the United Kingdom or SUSARs originating outside the United Kingdom where the sponsor has an ongoing UK trial involving the same product.
Detailed records of all adverse reactions must be kept. The MHRA may require copies of records if there is an investigation. There is also a requirement to submit development safety update reports (DSURs) accounting for all new available safety information received during the reporting period.
A declaration of the end of a clinical trial should be sent to the MHRA within 90 days of the global end of the trial. Any trial activities (eg, follow-ups and visits) should be completed before submitting the end of trial declaration form. Trial amendments may not be submitted once the declaration form has been received.
The sponsor is responsible for uploading the end of trial summary results within six months of the end of paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials.
What are the informed consent obligations with respect to clinical trial subjects?
Clinical trial subjects must give informed consent to participate in a trial. Before subjects give consent, the sponsor must give them full details of the trial’s nature, significance, implications and risks. Subjects must also be interviewed by the investigating team. Consent must be evidenced in writing, usually by signing a consent form. An ethics committee will consider the wording and information in the consent form. Throughout the trial, the subject’s willingness to continue participation should be reaffirmed periodically – particularly following any significant new information becoming available.
What are the insurance requirements for clinical trials?
Under the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), a clinical trial may be undertaken only if insurance or indemnity provisions have been made to cover the liability of the sponsor and investigator (this is also a good clinical practice requirement). Sponsors must have clinical trial insurance cover in place before trial approval is given. Ethics committees usually request separate insurance cover, rather than allowing a sponsor to self-insure.
In addition, sponsors usually agree to compensate patients for injuries under the relevant Association of the British Pharmaceutical Industry Compensation Guidelines.
What data protection issues should be considered when conducting clinical trials?
Clinical research is highly regulated with many processes and procedures in place to ensure that the principles of data protection are upheld, including:
- Research Ethics Committee approval;
- Health Research Authority (HRA) assessment; and
- good clinical practice.
Further, the General Data Protection Regulation (GDPR) requires organisations to process personal data in a lawful, fair and transparent way. When conducting trials, the following data protection measures should be considered:
- Safeguarding – the GDPR highlights the need for organisations to have processes in place to ensure that data is processed securely, accurately and in accordance with legal and ethical responsibilities. In addition, study-specific methods to safeguard participants’ data are also required – for example:
- stringent arrangements for securing and storing data;
- anonymising or pseudonymising data wherever possible;
- only collecting data that is needed (data minimisation); and
- minimising the number of participants recruited.
- Consent – the GDPR has strengthened the conditions for consent and assent. Informed, voluntary consent in clinical research is fundamental in protecting participants’ health and welfare, and is already a requirement of good clinical practice. In line with the GDPR, the consent and assent process in clinical research should ensure that organisations treat study participants in a fair and transparent way, providing information about:
- what their data will be used for;
- who will process it; and
- how it will be stored.
Clinical research organisations must also ensure that study participants have access to data protection and privacy policies.
- Research exemptions – the processing of special categories of data (including health data) is permitted under Article 9(2)(j) of the GDPR where:
[The] processing is necessary for… scientific… research purposes or statistical purposes in accordance with Article 89(1)… is proportionate to the aim pursued, respects the essence of the right to data protection and provides for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
Article 89(1) of the GDPR outlines certain safeguards that are likely to be present in most clinical research.
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
The relevant marketing authorisation procedure depends on the type of medicinal product being marketed and the number of EU countries in which the product will be marketed – for example:
- the national procedure to market a medicine only in the United Kingdom;
- the mutual recognition procedure to market a medicine in several EU member states where the product in question has already received a marketing authorisation in an EU member state at the time of application;
- the decentralised procedure to market a medicine for the first time in the United Kingdom and other named EU countries; and
- the centralised procedure to market certain kinds of medicines throughout the European Union.
What criteria are considered in granting marketing authorisation?
The Medicines and Healthcare products Regulatory Agency (MHRA) will grant a marketing authorisation only if it is satisfied that:
- the applicant has established the therapeutic efficacy of the medicine;
- the positive therapeutic effects of the medicine outweigh the risks to patients’ health or of the public associated with the medicine;
- the application and the accompanying materials are in accordance with the legislation; and
- the medicine's qualitative and quantitative composition is as described in the application.
What is the fee for obtaining marketing authorisation?
Various fees apply depending on what procedure is taken. Fees are listed on the MHRA’s website.
What is the validity period for marketing authorisation?
Once a marketing authorisation is granted, if the medicinal product is not placed on the market within three years, the marketing authorisation will no longer be valid. This also applies where, after being authorised and placed on the market, a medicinal product is taken off the market for a period of three consecutive years.
Marketing authorisations are valid for an initial term of five years. Once renewed, the marketing authorisation is usually valid indefinitely, unless there are specific safety concerns, in which case the European Medicines Agency or the MHRA can require one further five-year renewal period.
What are the consequences of failure to obtain marketing authorisation?
Regulations 79 to 88 of the Human Medicines Regulations 2012 provide for penalties for breaches of marketing authorisations, as well as other failures relating to the marketing authorisation and specific requirements of the legislation.
What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
The relevant rules on pharmacovigilance for medicines authorised through national procedures are set out largely in Title IX of the Code for Human Medicines Directive. Part 11 of the Human Medicines Regulations implements those requirements In the United Kingdom. These requirements include the obligation for marketing authorisation holders to:
- operate and regularly audit appropriate pharmacovigilance and risk management systems;
- monitor and report on the safety of their medicines throughout the entire product lifecycle; and
- detect any change to their risk-benefit balance.
What data protection issues should be considered when conducting pharmacovigilance activities?
Pharmacovigilance data may include:
- information that identifies a patient and the reporter; and
- personal data about the patient (eg, sensitive personal data and contact details).
Although the General Data Protection Regulation (GDPR) considers obtaining data subject’s consent before processing as the fundamental basis of data protection law, there are legal grounds other than consent for processing pharmacovigilance data – principally:
- Article 6(1)(f): “processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party”; and
- Article 9(2)(i): Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union law or Member States law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subjects, such as professional secrecy.
Under Article 17(1) of the GDPR, a data subject has the right to obtain the erasure of personal data without undue delay from the data controller. However, under Article 17(3)(d), the so-called ‘right to be forgotten’ does not apply if the processing takes place:
for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) in so far as the right referred to in paragraph 1 is likely to render impossible or seriously impair the achievement of the objectives of that processing.
The general principle of data minimisation and purpose limitation should apply to pharmacovigilance data processing. This type of data should not be processed for any other purpose and should not be held after the data storage period expires.
As pharmacovigilance data is often transferred across borders, relevant systems must be in place to ensure GDPR compliance relating to international data transfers.
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
There are two pricing arrangements for branded medicines:
- Pharmaceutical Price Regulation Scheme (PPRS) – this scheme establishes controls on the price of branded drugs sold to the National Health Service (NHS) and covers all licensed, branded, prescription medicines sold to the NHS. It does not cover generics or branded products available without prescription (except when prescribed). The PPRS is a voluntary scheme where companies repay the Department of Health based on a percentage of the industry's overspend.
- Statutory scheme – this scheme is imposed on all companies that do not opt into the PPRS and enforces a price cut (currently set at 15%) in the maximum price of branded health service medicines on sale. The scheme can also establish a maximum price that can be charged for a specific medicine and sets out the information that companies must provide to enable price control mechanisms to operate. Generic, unbranded and out-of-patent medicine prices are determined by the secretary of state and published in the NHS Drug Tariff.
What is the structure for state reimbursement of medicinal product costs?
The Health and Social Care Act 2012 sets out a statutory basis for the national tariff – a set of prices paid by commissioners to providers (including NHS foundation trusts and other NHS trusts) for all services carried out in the NHS. The medicine margins are reviewed periodical and adjustments are made to the reimbursement arrangements as necessary.
Pharmacies are reimbursed by the NHS for the products they dispense, based on the submission of NHS prescriptions and the reimbursement prices set in the NHS Drug Tariff (or, where no reimbursement price is set in the Drug Tariff, at the manufacturer's list price). They often purchase stock direct from pharmaceutical companies and wholesalers at lower prices and can therefore benefit from the marginal difference between the purchase and reimbursement prices.
In addition, patients pay a prescription charge, currently set at £8.80. Children, older people and certain medically exempt individuals do not pay prescription charges.
Advertising and labelling
How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?
Advertising medicines to healthcare professionals and the public is regulated by Part 14 of the Human Medicines Regulations 2012, which implements Title VIII of the Community Code, Medicines and Healthcare products Regulatory Agency (MHRA) guidance (eg, the Blue Guide) and industry codes of practice.
Controlling medicine advertising by self-regulation involves the following bodies and relevant codes of practice, each of which includes detailed requirements which reflect and extend beyond relevant legislative requirements:
- the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority – ABPI Code of Practice for prescription-only medicines;
- the Proprietary Association of Great Britain (PAGB) – Consumer Code and Professional Code for over-the-counter medicines; and
- the Advertising Standards Authority (ASA) – UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (co-regulator of BCAP code, as above). The ASA Committee of Advertising Practice offers a free advice service for such advertisements aimed at the public.
Do any special rules apply to online advertising of medicinal products?
Generally, the same rules apply to digital communications as to other forms of advertising. Advertising medicines directed to a UK audience through the Internet is therefore subject to the same controls as for other forms of advertising, including the ABPI and the PAGB codes.
What are the packaging and labelling requirements for medicinal products?
The MHRA approves all packaging and labelling information for medicines sold in the United Kingdom, including the information that must be provided. The labelling and patient information leaflet requirements are set out in Part 13 of the Human Medicines Regulation – for example:
- labels must be clear;
- healthcare professionals and patients must be able to easily identify the medicine by the label;
- all information on packaging for licensed medicines must be printed directly on the packaging;
- over labelling is prohibited;
- medicines must include a patient information leaflet if the label does not contain all of the necessary information; and
- labels must include warnings for how to use of the medicine safely.
For certain medicines, packaging must also indicate whether the medicine is intended for babies, children or adults, and any warnings or special precautions which apply to the medicine. The name of a medicine must also be expressed in braille on the outer packaging and the patient information leaflet must be available on request in formats suitable for blind and partially sighted persons.
From 9 February 2019, packaging of medicinal products supplied in the United Kingdom (with a few exceptions) will need to feature a unique identifier (a two-dimensional barcode) and an anti-tampering device to prevent falsified medicines entering the supply chain.
How is the promotion of off-label use regulated?
The promotion of unlicensed or off-label medicines is prohibited under Sections 279 and 280 of the Human Medicines Regulations).
Certain healthcare professionals may prescribe a licensed medicine off-label or an unlicensed medicine subject to:
- their clinical competence;
- their statutory bodies’ professional codes and ethics; and
- their employer’s prescription policy.
Relations with healthcare professionals
Gifts and incentives
What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?
The provision of hospitality, gifts and inducements to prescribe to healthcare professionals or other decision makers within healthcare organisations are subject to the Bribery Act 2010, which is enforced by the Serious Fraud Office.
Under these circumstances, three kinds of breach can apply:
- Sections 1 and 2 – bribing a person and accepting a bribe (main offence);
- Section 7 – failing to prevent bribery (corporate offence); and
- Section 6 – bribing a foreign public official.
The Serious Fraud Office has entered into a memorandum of understanding with the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority. The memorandum covers the activities subject to the ABPI Code and states that self-regulation under this code should be the first means of dealing with relevant complaints. The ABPI Code governs the promotional activities of its members and any non-members which agree voluntarily to be bound by the code.
There is no statutory provision in the United Kingdom obliging companies to publicly disclose any transfers of value to healthcare professionals and healthcare organisations. However, the ABPI Code sets out the disclosure requirements, which implement the European Federation of Pharmaceutical Industries and Associations Disclosure Code. Companies must document and publicly disclose annually certain transfers of value made directly or indirectly to healthcare professionals and healthcare organisations located in Europe.
How can a liability claim for a defective medicinal product be brought?
Claimants have three years from the date on which the cause of action accrued (ie, the date of injury or death) or the date of knowledge of certain facts in which to bring a claim for personal injury in negligence.
The ‘date of knowledge’ is the date on which the claimant became aware of the identity of the defendant, the injury’s significance and that it was wholly or partly attributable to the defendant’s alleged negligence, nuisance or breach of duty.
The courts may allow a claim to proceed outside the limitation period where they consider that it is entirely just to do so.
Where the Consumer Protection Act 1987 applies, a claimant also has three years from the date on which the cause of action accrued or the date of knowledge to bring a claim; however, the act sets out an additional limitation period: a cause of action is extinguished 10 years after the date on which the product was supplied. There is no discretion to extend.
For a contractual claim, the limitation period is six years from the date on which the cause of action accrued, in principle, when the breach of contract occurred. Special rules apply to persons under a disability. The 10-year longstop for Consumer Protection Act claims still applies.
Which parties can be held liable for a defective medicinal product?
In negligence claims, a defendant is liable if they owe and have breached a relevant duty of care in relation to a defective product, which has resulted in damage to the claimant. This could include, for example, distributors and sellers, insofar as their activities affect the safety of the product. Prescribing physicians could also potentially be liable in negligence (eg, for prescribing a medicine to a patient if that use is contra-indicated by the summary of product characteristics). Pharmacists could be liable for dispensing contrary to a doctor's prescription.
Under the Consumer Protection Act, the product’s producer is primarily liable (normally the manufacturer); however, an own brander or persons that consider themselves to be the producer may be liable instead.
Further, claimants need not pursue defendants beyond EU borders. For Consumer Protection Act purposes, the first importer of a product into the European Union is deemed to be the producer. A product’s supplier (eg, the retailer, distributor or wholesaler) can be liable instead of the manufacturer if it fails to inform the claimant of the producer’s identity, or at least the person who supplied the supplier.
Claims for breach of contract can be brought only against the immediate supplier of the defective product to the injured party. Where medicines are prescribed by the National Health Service, case law establishes that there is no contract between the patient and the prescribing doctor or the pharmacist dispensing the drugs. Contractual claims generally arise only where medicines are supplied privately or for over-the-counter products.
What remedies are available to successful claimants?
The following remedies are available to successful claimants:
- Generally, the law aims to put the victim of negligence in the position that they would have been in had the negligence not occurred. Damages are available to compensate the claimant for losses that were a direct and reasonably foreseeable consequence of the injury. As a rule, in the sphere of product liability, no claim can be made for negligence causing pure economic loss (ie, financial loss that does not arise from physical injury or damaged property).
- In a strict liability claim under the Consumer Protection Act, damages are available to compensate the injured person for death or personal injury (including any disease or impairment of a person’s physical or mental condition).
- The remedies available where a product fails to comply with contractual terms are governed by the general principles of contract law. These remedies depend on the classification of the term breached. Contract terms in English law can be classified as follows:
- Conditions – a condition is seen as a vital term of a contract. Breach of condition entitles the innocent party to either repudiate the contract (unless, as a buyer, they have accepted the goods) or claim damages (or both) on the basis that they have not received the benefit promised. Repudiation will bring the contract to an end.
- Warranties – breach of warranty entitles the innocent party to a claim for damages only. Terms that are incapable of being classified as conditions or warranties are considered innominate or intermediate terms.
- Innominate terms – the remedy for breach of an innominate term depends on the effect of the breach on the injured party at the time of the breach. If the effect of the breach substantially deprives the innocent party of the whole of the benefit of the contract, then it will be a serious breach of the innominate term and the remedy will be the same as for a breach of condition; otherwise, the remedy will be the same as for a breach of warranty.
Damages for breach of contract are usually to compensate for economic loss, but damages may be awarded to compensate for physical injuries caused by defective goods. Damages are not usually awarded for anxiety and stress.
Exclusion and limitation
On what grounds can liability be excluded?
The seller will not be liable for faults drawn to the buyer's attention before the contract, or which the buyer should have detected when examining the goods. In addition, the following defences are available:
- contributory negligence – where the claimant's own negligence contributed towards their loss (although this can result only in a reduction of the amount of compensation to be awarded);
- voluntary assumption of the risk by the claimant – where the claimant knew the risks of the product but chose to accept them; and
- illegality – where the claimant was engaged in illegal activity at the time the loss was suffered.
Certain contractual terms are implied by statute. For example, under the Consumer Rights Act 2015, liability for breach of such terms cannot be excluded or restricted against a consumer (Sections 31 and 47). Further, other terms which seek to limit or exclude liability in a consumer contract may be regarded as unfair and therefore unenforceable. A term is ‘unfair’ if, contrary to the requirement of good faith, it causes a significant imbalance in the parties' rights and obligations under the contract to the detriment of the consumer (Sections 62, 63 and Schedule 2).
Liability for death or personal injury resulting from negligence cannot be excluded or restricted by a consumer contract, by a consumer notice (Section 65) or in contracts between businesses (Section 2(1) of the Unfair Contract Terms Act).
Other terms which seek to limit or exclude liability for negligence in a consumer contract will be unenforceable if they are regarded as unfair (Sections 62, 63 and Schedule 2 of the Consumer Rights Act). In contracts between businesses, liability in respect of negligence can be limited provided the contract term or notice is reasonable (Section 2(2) of the Unfair Contract Terms Act).
In contracts between businesses and on a supplier's written standard terms, liability for breach of an express term of a contract can be limited or excluded only to the extent that it is reasonable to do so (Section 3 of the Unfair Contract Terms Act).
Strict liability cannot be excluded (Section 7 of the Consumer Protection Act 1987).
What preventive steps can be taken to limit liability?
The seller will not be liable for faults drawn to the buyer's attention before the contract or faults which the buyer should have detected when examining the goods.
Ensuring terms and conditions or sale and purchase contracts are drafted containing proper warranties and indemnities.
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
With regard to medicines authorised under the centralised procedure, enforcement action can be taken by the European Commission under the Penalties Regulation (Regulation (EC) 658/2007). In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) exercises its enforcement powers based on:
- the Human Medicines Regulations 2012;
- the Consumer Protection Act 1987;
- the Medical Devices Regulations 2002; and
- the General Product Safety Regulations 2005.
The MHRA’s enforcement powers include the launch of criminal proceedings in appropriate circumstances. However, in practice, prosecutions are rare. The agency prefers to use alternative enforcement powers, including issuance of warning letters, notices and formal cautions.
Following an investigation, the MHRA has a range of penalties. It can issue warning letters or formal cautions, suspend, revoke or vary licences or seek injunctions from the civil courts (eg, to prevent the supply of medicines that have not been properly authorised). There are also powers relating to specific areas of law (eg, infringement notices for breach of pharmacovigilance requirements and notices regarding advertising duties).
The MHRA may also bring criminal prosecutions, punishable by an unlimited fine (on summary conviction) or by an unlimited fine or up to two years’ imprisonment or both (on indictment).
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
In addition to the prohibited acts under the Bribery Act 2010, Regulation 300(1) of the Human Medicines Regulations prohibits the supply, offer or promise of any gift, pecuniary advantage or benefit to healthcare service providers in connection with the promotion of medicinal products, unless it is inexpensive and relevant to medical practice.
Healthcare professionals must similarly refrain from accepting or soliciting such benefits (Regulation 300(4)). Examples of practices that fall within the scope of Regulation 300(1) include:
- price promotions;
- bonus schemes; and
- merchandising offers.
The provision of hospitality to healthcare professionals, which includes sponsorship and travel expense payments, is restricted under Regulation 300(2). Guidance on how the provisions will be applied is set out in Section 6.14 of the MHRA’s Blue Guide. All financial relationships between healthcare professionals and their suppliers must also comply with the Bribery Act.
In addition to the legislative framework, the Prescription Medicines Code of Practice Authority may impose penalties where a breach of the Association of the British Pharmaceutical Industry Code is found to have occurred. If so, the relevant company must give an undertaking that the practice in question has ceased immediately and that all possible steps have been taken to avoid a similar breach in future. An undertaking must be accompanied by details of the action taken to implement the ruling. Detailed case reports are published once the case has been concluded.