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Trends and developments
Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?
From an EU perspective, two forthcoming legal developments will have an impact on the pharmaceutical industry: the entry into force of the EU Clinical Trials Regulation (536/2014) and the entry into force of the EU General Data Protection Regulation (2016/679).
The Clinical Trials Regulation was adopted on April 16 2014. It is expected to harmonise the approval and supervision processes for clinical trials throughout the European Union via a dedicated IT infrastructure, the EU Portal and EU Database. The entry into force of the Clinical Trials Regulation is dependent on the related EU Portal and EU Database being fully functional. This step is expected to be completed by October 2018.
The EU Data Protection Directive (95/46/EC) governs the collection, processing and transfer of personal data, including health data, in the European Union. The Data Protection Directive governs, among other things, the activities of pharmaceutical companies engaged in clinical trials and pharmacovigilance activities in the European Union. The General Data Protection Regulation, repealing the Data Protection Directive, entered into force on May 24 2016 and will apply from May 25 2018. The General Data Protection Regulation will introduce new data protection requirements in the European Union as well as substantial fines for breaches of the data protection rules.
What is the primary legislation governing medicinal products in your jurisdiction?
The primary EU legislation governing medicinal products includes:
- the EU Community Code (Directive 2001/83/EC), which governs, among other things, marketing authorisation, manufacturing, labelling, distribution and advertising of medicinal products in the European Union;
- the European Medicines Agency (EMA) Regulation (726/2004), which governs, among other things, the authorisation of medicinal products in accordance with the centralised procedure and the responsibilities of the EMA; and
- the EU Clinical Trials Directive (2001/20/EC), which sets out the requirements for the conduct of clinical trials in the European Union.
Additional legislation adopted at EU level governs specific categories of medicinal product, such as advanced therapy medicinal products, orphan medicinal products, traditional herbal medicinal products and vaccines.
Are any legislative changes proposed or expected in the near future?
The new EU Clinical Trials Regulation (536/2014), repealing the Clinical Trials Directive, was adopted on April 16 2014. The regulation is expected to enter into force by October 2018, although this deadline may be extended.
Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?
The EMA is responsible for, among other things, the scientific evaluation of applications for marketing authorisations for medicinal products within the centralised procedure and the monitoring of the safety of medicines through the coordination of pharmacovigilance activities in the European Union.
The European Commission is responsible for, among other things, adopting decisions to grant marketing authorisations in relation to medicinal products according to the centralised procedure.
In addition, in each EU member state national authorities are responsible for the regulation and authorisation of medicinal products at national level.
Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?
Trade in medicinal products must comply with the general EU provisions governing:
- competition, including:
- the Treaty on the Functioning of the European Union;
- Regulation 1/2003 on the implementation of the rules on competition laid down in Articles 81 and 82 of the treaty; and
- the guidelines adopted by the European Commission;
- international trade, including the Customs Code (Regulation 2913/92);
- data protection, including the Data Protection Directive and member states’ related implementing legislation; and
- consumer protection, including:
- the EU Unfair Commercial Practices Directive (2005/29/EC);
- the EU Misleading and Comparative Advertising Directive (2006/114/EC); and
- member states’ related implementing legislation.
In addition, EU Regulation 953/2003 on avoiding the trade diversion into the European Union of certain key medicines governs the import of medicines sold at discounted prices in developing countries. Regulation 953/2003 aims to encourage pharmaceutical companies to make medicinal products available at heavily reduced prices, preventing cheap medicines from being imported into the European Union.
Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?
The Community Code does not apply to:
- medicinal products which are prepared in a pharmacy in accordance with a medical prescription for an individual patient (‘the magistral formula’);
- medicinal products which are prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by that pharmacy (‘the officinal formula’);
- intermediate products which are intended for further processing by an authorised manufacturer;
- any radionuclides in the form of sealed sources;
- whole blood, plasma or blood cells of human origin, except for plasma which is prepared by a method involving an industrial process; and
- any advanced therapy medicinal product which is prepared on a non-routine basis according to specific quality standards, and used within the same EU member state in a hospital under the exclusive professional responsibility of a medical practitioner in order to comply with an individual medical prescription for a custom-made product for an individual patient.
What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?
The total or partial manufacture of medicinal products, including investigational medicinal products, must be based on a valid manufacturing authorisation granted by the competent authority of the EU member state where the manufacture is carried out. The Community Code (Directive 2001/83/EC) sets out only minimum common rules applicable to manufacturing authorisation procedures in the European Union. The Community Code sets out the minimum requirements that applicants must meet in order to obtain a manufacturing authorisation. The Community Code also provides that the time taken for the procedure for granting the manufacturing authorisation must not exceed 90 days from the day on which the competent authority receives the application.
What is the fee for obtaining authorisation?
The fees for obtaining a manufacturing authorisation of medicinal products vary according to the EU state concerned or whether the product is authorised through the centralised procedure.
What is the validity period for authorisation?
The validity of the manufacturing authorisation varies according to the EU member state concerned.
How robust are the standard good manufacturing practices followed in your jurisdiction?
The holder of a manufacturing authorisation must comply with the principles and guidelines of good manufacturing practices for medicinal products, and must use as starting materials only active pharmaceutical ingredients which have been manufactured in accordance with EU good manufacturing practice. The European Commission adopted the principles and guidelines of good manufacturing practice in in the form of Commission Directive 2003/94/EC. In addition, the European Commission published detailed good manufacturing practice guidelines in EudraLex (Volume 4).
EU member states must take appropriate measures to ensure that the manufacture of medicinal products on their territory complies with EU good manufacturing practice requirements, including by repeated and unannounced inspections. The European Medicines Agency (EMA) coordinates member states' supervision and inspection of manufacturers.
What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?
If an applicant fails to obtain a manufacturing authorisation, it will not be authorised to manufacture totally or partially medicinal products in the EU member state concerned. If the holder of a manufacturing authorisation is found not to comply with EU good manufacturing practices following an inspection, a statement of good manufacturing practice non-compliance is issued and entered in the EMA operated ’EudraGMDP’ database. The authorities which have granted the manufacturing authorisation will then evaluate whether a manufacturing authorisation should be totally or partially suspended, varied or revoked as a result of the non-compliance. In addition, if the statement of non-compliance concerns the manufacture of investigational medicinal products used in a clinical trial, the national competent authority which authorised the clinical trial must evaluate the impact of the non-compliance statement on the quality and safety of the investigational medicinal product.
How are the distribution and storage of medicinal products regulated?
Activity as a medicinal products wholesaler must be based on an authorisation issued by competent authorities of individual EU member states. A wholesale distribution authorisation is valid in relation to specifically identified premises located on the territory of the issuing EU member state. The Community Code provides only minimum common rules applicable to wholesale distribution authorisation procedures in the European Union. In particular, the Community Code sets out the minimum requirements that must be fulfilled by applicants in order to obtain a wholesale distribution authorisation. The Community Code also provides that holders of the distribution authorisation must comply with the principles and guidelines of good distribution practice for medicinal products, as set out in Commission Guidelines 2013/C 343/01 on Good Distribution Practice of medicinal products for human use.
Import and export
How are the import and export of medicinal products regulated?
The import of medicinal products from third countries to an EU member state must be based on a valid manufacturing authorisation. A valid manufacturing authorisation is also required when the medicinal products manufactured are intended for export (see “Manufacture” section above).
The Community Code provides minimum common rules that apply to the import of medicinal products into the European Union. Article 51.1 of the Community Code provides that each batch imported from a third country must undergo in an EU member state a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products, in accordance with the requirements of the relevant marketing authorisation. These controls are not required when the medicinal products are imported from third countries which concluded mutual recognition agreements with the EMA.
Are parallel imports permitted in your jurisdiction?
The European Commission Communication on Parallel Imports of Proprietary Medicinal Products for Which Marketing Authorisations Have Already Been Granted (COM (2003) 839) provides that parallel imports of a medicinal product are a lawful form of trade within the EU internal market. However, the European Commission acknowledges that EU member state measures restricting parallel imports may be justified on the grounds of protecting industrial and commercial property or human health and life. However, EU member state authorities must demonstrate that such measures are necessary and proportionate.
Sale and purchase
What rules govern the dispensing, sale and purchase of medicinal products?
The Community Code provides that when a marketing authorisation for a medicinal product is granted, the competent authorities must specify the classification of the medicinal product as a prescription-only medicinal product or an over-the-counter (OTC) product (ie, not subject to prescription). The Community Code provides the basic criteria that must be applied by the competent authorities in determining the classification of medicinal products. The Community Code also provides the main rules governing the change of classification of a medicinal product.
Subcategories of classification for both prescription-only and OTC medicinal products have been developed at national level in individual EU member states. For OTC medicinal products, such classification can include the limitation of availability to pharmacies only or making them available on general sale.
Are there any restrictions on the online sale and purchase of medicinal products?
EU law does not prevent or restrict online sale and purchase of medicinal products. Without prejudice to national legislation prohibiting online sale and purchase of medicinal products, the Community Code provides the minimum conditions that must be followed by online pharmacies and retailers of medicinal products. In addition, the EU Falsified Medicines Directive (2011/62/EC) introduced a common, EU-wide logo to identify legal online pharmacies and retailers of medicinal products. The Commission Implementing Regulation (699/2014) established the design of a common logo and set out the technical, electronic and cryptographic requirements for ensuring the authenticity of the logo.
Named patient supply
What rules govern named patient supply of pre-launch medicinal products?
Pursuant to Article 5 of the Community Code, EU member states can allow named patient supply of non-authorised medicinal products under certain conditions. Named patient programmes can be implemented only at the initiative of an authorised healthcare professional for use by hisindividual patients, and on the healthcare professional’s direct personal responsibility.
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
The EU Clinical Trials Directive (2001/20/EC) provides the main rules governing the authorisation of clinical trials in the European Union. Before commencing a clinical trial, the sponsor must obtain:
- the favourable opinion the clinical trial by the relevant ethics committee (an independent body) in the EU member state in which the sponsor plans to conduct the clinical trial; ethics committees comprise healthcare professionals and non-medical members whose responsibility is to protect clinical trial subjects; and
- authorisation from the competent authority of the EU member state in which the sponsor plans to conduct the clinical trial. Consideration of a valid request for authorisation by the competent authority may not exceed 60 days.
The application must include administrative information and the data necessary to demonstrate the quality, safety and efficacy of the investigation medicinal product.
How robust are the standard good clinical practices followed in your jurisdiction?
The Clinical Trials Directive, the EU Good Clinical Practices Directive (2005/28/EC) and the guidance documents contained in EudraLex Volume 10 provide the standard good clinical practices to be followed during the conduct clinical trials in the European Union. Competent authorities in the EU member states conduct inspections for compliance with existing EU good clinical practices. Inspections can be conducted on facilities, records, quality assurance arrangements and any other resources that are deemed by the competent authority to be related to the clinical trial. Inspections can be conducted at the site of the trial, at the sponsor and clinical research organisation’s facilities, or at other establishments which the competent authority sees fit to inspect.
In addition, the manufacture of investigational medicinal products must comply with good manufacturing practices. To verify compliance of investigational medicinal products with good manufacturing practices, inspections must be conducted by the competent authority of the relevant EU member state.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
Reporting requirements In accordance with EudraLex Volume 10 on clinical trials guidelines, the sponsor of a clinical trial must submit a summary of the clinical trial report to the competent authority and the ethics committee in the EU member states where the clinical trial was conducted within one year after completion of the trial.
Disclosure requirements All clinical trials of investigational medicinal products in the European Union must be registered on the European Clinical Trials Database (EudraCT). It is mandatory for clinical trial summary results to be posted in EudraCT within six to 12 months following the end of the trial, depending on the type of clinical trial. It is the sponsor’s responsibility to ensure that clinical trial summary results are posted in EudraCT.
What are the informed consent obligations with respect to clinical trial subjects?
The Clinical Trials Directive provides that informed consent to take part in a clinical trial must be given freely by the trial subject after having been duly informed of the nature, significance, implications and risks related to the clinical trial. Where the trial subject is incapable of giving consent, consent must be given on his or her behalf by his or her legal representative. A trial subject may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent.
What are the insurance requirements for clinical trials?
The Clinical Trials Directive provides that a clinical trial may be conducted only if provision is made for insurance or indemnity to cover the liability of both the sponsor and the investigator.
What data protection issues should be considered when conducting clinical trials?
The collection, processing and transfer of personal data of study subjects must be conducted in accordance with the requirements provided in the Data Protection Directive (95/46/EC) and the related implementing provisions of the EU member states.
Sponsors and investigators must take into account the fact that the processing of health data can be conducted only in specific circumstances. These circumstances include the study subject having provided his or her explicit consent to the processing of his or her health data.
The Data Protection Directive defines the ‘data controller’ as the entity that determines the purposes and means of the processing of personal data carried out in the European Union. The sponsor of a clinical trial is commonly considered to be the data controller. Sponsors of clinical trials which are not established in the European Union and wish to transfer trial subjects' data outside the European Union must take into account the following issues:
- When the sponsor is not established in the European Union, it must designate a data protection representative in each EU member state in which a trial site is located and where, consequently, study subject personal data is processed.
- The transfer of personal data to third countries which does not ensure an adequate level of protection of personal data is permitted only through the authorised means described in the Data Protection Directive.
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
In the European Union, there are several routes for obtaining marketing authorisation for a medicinal product. A marketing authorisation for a medicinal product can be issued either by the European Commission for the entire EU market (the ‘centralised procedure’) or by the national competent authorities through the mutual recognition, decentralised or national authorisation procedures. The marketing authorisation holder must be established within the European Union.
Centralised procedure The centralised procedure is governed by the EU European Medicines Agency (EMA) Regulation (726/2004). The EMA Committee for Medicinal Products for Human Use carries out a scientific evaluation of the application and prepares an opinion for the European Commission. The European Commission, based on a positive opinion from the EMA and having consulted the Standing Committee for Medicinal Products for Human Use, adopts the decision granting a marketing authorisation. A marketing authorisation granted through the centralised procedure is valid for the entire European Union plus Iceland, Liechtenstein and Norway.
The centralised procedure is mandatory for certain medicinal products listed in the EMA Regulation, including advanced-therapy medicinal products and orphan medicinal products, and optional for certain other medicinal products.
National authorisations, decentralised procedure and mutual recognition procedure National authorisations are granted by EU member states through the national competent authorities. Such authorisations are valid only in the EU member state in which they are granted.
Marketing authorisations for more than one EU member state can be obtained through the decentralised procedure and the mutual recognition procedure, both of which are governed by the Community Code (Directive 2001/83/EC).
The decentralised procedure applies to medicinal products that have not yet been authorised in an EU member state. The applicant may submit identical applications for marketing authorisation simultaneously in all the EU member states where it intends to obtain a marketing authorisation, and choose one of these as the reference EU member state. The reference state carries out the initial evaluation and issues a draft assessment report. The other EU member states where the applicant has submitted applications provide comments. If the application is successful, national marketing authorisations will be issued in the reference EU member state and the other concerned states.
The mutual recognition procedure applies to medicinal products that have already been authorised in an EU member state. The other concerned member states are asked to mutually recognise the marketing authorisation already issued by the reference member state. If the applicant is successful, each EU member state concerned will issue a national marketing authorisation. Should any concerned member state refuse to recognise the original national authorisation, the procedure goes through various steps and is ultimately referred to the European Commission for decision.
What criteria are considered in granting marketing authorisation?
The Community Code provides that an applicant for a marketing authorisation must demonstrate the quality, safety and efficacy of the medicinal product for which authorisation is sought. The demonstration of efficacy, safety and quality of the medicinal product is achieved through the submission of information on the chemical properties manufacturing and pharmaceutical aspects of the medicinal product, as well as the results of pre-clinical tests and clinical trials. Annex I to the Community Code describes the particulars and documents that must be provided with an application for marketing authorisation in the European Union.
Subject to the conditions provided by the Community Code, applications for marketing authorisation can refer to the results of pre-clinical tests and clinical trials of a medicinal product already authorised in the European Union. Among these abridged applications are applications for marketing authorisation for generic medicinal products.
What is the fee for obtaining marketing authorisation?
The EMA charges fees for marketing authorisation applications according to the centralised procedure. Thecurrent basic fee for a marketing authorisation application is €278,800 for a medicinal product with a single strength, associated with one pharmaceutical form and one presentation.
The fees for obtaining a marketing authorisation according to the national procedure, decentralised procedure or mutual recognition procedure vary according to the EU member state concerned.
What is the validity period for marketing authorisation?
The Community Code and the EMA Regulation provide that a marketing authorisation granted in the European Union has an initial duration of five years.
After the five-year period, the marketing authorisation may be renewed based on a re-evaluation of the risk-benefit balance of the medicinal product by the European Commission or the national competent authority. To this end, the marketing authorisation holder must request the renewal of its authorisation to the EMA or the national competent authorities at least nine months before the marketing authorisation expires. The applicant must submit updated data concerning the quality, safety and efficacy of the medicinal product, including all variations introduced since the marketing authorisation was granted.
Once renewed, the marketing authorisation is valid indefinitely unless the European Commission or the national competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
What are the consequences of failure to obtain marketing authorisation?
The company seeking to place medicinal products on the EU market can re-apply for marketing authorisation to the EMA or the national competent authority.
What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
Within the framework of the EU pharmacovigilance system, the European Medicines Agency (EMA) coordinates member states' activities in connection with monitoring the safety of medicines placed on the EU market. Suspected adverse reactions must be entered in the online EudraVigilance information system managed by the EMA. The reporting of suspected adverse reaction in EudraVigilance is obligatory for marketing authorisation holders and national competent authorities.
The EMA Pharmacovigilance Risk Assessment Committee evaluates signals from EudraVigilance and may recommend regulatory actions as a result. If the EMA is concerned that the risk-benefit profile of a medicinal product has varied, it can adopt an opinion advising that the medicinal product’s marketing authorisation be varied and requiring the marketing authorisation holder to conduct post-authorisation safety studies. The opinion is then submitted to the European Commission for approval.
What data protection issues should be considered when conducting pharmacovigilance activities?
The EMA Guideline on Good Pharmacovigilance Practices (EMA/541760/2011) provides that the fundamental right to personal data protection must be fully and effectively guaranteed in all pharmacovigilance activities. As part of a record management system, specific measures should be taken at each stage of the storage and processing of pharmacovigilance data to ensure data security and confidentiality. This should involve the strict limitation of access to documents and databases to authorised personnel respecting the medical and administrative confidentiality of the data.
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
Pricing and reimbursement of medicinal products falls within the exclusive competence of the EU member states. As a result, there are different statutory health schemes and the pricing and reimbursement of medicinal products is subject to different rules in each state. However, there is some harmonisation regarding the transparency of pricing and reimbursement schemes provided through the EU Transparency Directive (89/105/EEC). The directive provides that pricing measures should be based on objective and verifiable criteria. It also provides for timelines within which pricing and reimbursement decisions should be taken.
Notwithstanding the lack of EU legislation governing pricing and reimbursement procedures, the health technology assessment (HTA) of medicinal products is becoming an increasingly common part of pricing and reimbursement decisions in some EU member states. In addition, a network of EU HTA organisations has been established to facilitate and support the exchange of scientific information concerning HTAs. This could lead to harmonisation between EU member states of the criteria taken into account in the conduct of HTA and their impact on pricing and reimbursement decisions.
What is the structure for state reimbursement of medicinal product costs?
EU member states are free to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the reimbursement levels of medicinal products. EU member states may approve a specific price or level of reimbursement for the medicinal product, or alternatively can adopt a system of direct or indirect controls on the profitability of the company responsible for placing the medicinal product on the market, including volume-based arrangements and reference pricing mechanisms.
Advertising and labelling
How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?
The Community Code (Directive 2001/83/EC) sets out specific provisions governing the advertising of medicinal products, including:
- a prohibition on the advertisement of medicinal products without a valid marketing authorisation in the EU and the off-label promotion of medicinal products;
- the advertising must encourage the rational use of the medicinal product by presenting it objectively and without exaggerating its properties or being misleading;
- an obligation to ensure that the promotion of a medicinal product complies strictly with the particulars listed in its summary of product characteristics; and
- a prohibition on the promotion of prescription-only medicinal product to non-healthcare professionals. Any information concerning the availability or properties of a prescription-only medicinal product that is intended to or may influence the behaviour of patients or the general public constitutes the illegal direct-to-consumer promotion of prescription-only medicinal products.
EU member states’ implementing provisions may provide further requirements. In addition, industry codes of conduct may provide additional rules governing advertising and promotional interactions with healthcare professionals and the general public.
Do any special rules apply to online advertising of medicinal products?
The rules in the Community Code governing the advertisement of medicinal products extend to online advertising. However, the code includes no special provisions for the online advertisement of medicinal products. The provisions in force in individual EU member states and industry codes of conducts may provide specific requirements.
What are the packaging and labelling requirements for medicinal products?
The Community Code lists the particulars that must appear on the outer packaging of a medicinal product or, where there is no outer packaging, on the immediate packaging. The particulars must be in accordance with the summary of product characteristics. European Commission and EMA guidelines provide additional requirements for labelling of medicinal products authorised in the European Union.
How is the promotion of off-label use regulated?
The Community Code prohibits the promotion of a product that is not authorised. It also prohibits the promotion of an authorised medicinal product for uses not included in the particulars listed in the summary of product characteristics. Both of these activities constitute promotion of off-label uses.
Pharmaceutical companies cannot proactively begin a discussion with healthcare professionals concerning off-label uses of medicinal products. Moreover, in no circumstances can a response be provided to unsolicited questions concerning off-label use received from individuals other than healthcare professionals (this includes patients, patient organisations or members of the general public).
Relations with healthcare professionals
Gifts and incentives
What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?
The Community Code (Directive 2001/83/EC) prohibits pharmaceutical companies from supplying, offering or promising gifts, pecuniary advantages or benefits in kind to healthcare professionals. The only exception to this prohibition relates to gifts which are inexpensive and relevant to the practice of medicine or pharmacy.
Hospitality may be provided to healthcare professionals at promotional and scientific events provided that this hospitality is strictly limited and is not the main purpose of the event. Hospitality must never be extended to persons other than healthcare professionals.
All gifts and hospitality provided by pharmaceutical companies to healthcare professionals must comply with the national legislation and industry rules applicable in the EU member state where the healthcare professionals are licensed to practise.
How can a liability claim for a defective medicinal product be brought?
The liability regime for defective medicinal products is governed by the EU Liability for Defective Products Directive (85/374/EEC) and the related implementing legislation in the individual EU member states. The procedure for bringing a defective medicinal product claim to the competent authorities is governed by the applicable national provisions.
Which parties can be held liable for a defective medicinal product?
The Liability for Defective Products Directive provides that a producer is liable for damage caused by a defect in its product. The term ‘producer’ includes:
- the manufacturer of a finished product;
- the producer of any raw material; and
- any person who, by putting his or her name, trademark or other distinguishing feature on the product presents himself or herself as its producer.
What remedies are available to successful claimants?
The Liability for Defective Products Directive provides that protection of the consumer requires compensation for death and personal injury. However, the directive does not govern the specific remedies available to successful claimants. This is governed by the national laws of the individual EU member states.
Exclusion and limitation
On what grounds can liability be excluded?
Article 7 of the Liability for Defective Products Directive describes the circumstances in which the producer is not liable for a defective product. The related implementing provisions in the EU member states may provide further the grounds on which liability can be excluded.
What preventive steps can be taken to limit liability?
The preventive steps that can be taken to limit liability can be identified based on the specific provisions in force in individual EU member states.
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
There are considerable differences among EU member states in their approach to the implementation and enforcement of the rules governing medicinal products and clinical trials.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
EU member states have adopted laws on bribery, fraud and anti-corruption which govern interactions between pharmaceutical industry and healthcare professionals.
The Falsified Medicines Directive (2011/62/EC) introduced harmonised safety measures to allow verification of the authenticity of medicinal products. These measures include:
- a common, EU-wide logo to identify legal online pharmacies and retailers of medicinal products – the Implementing Regulation (699/2014) provides the technical, electronic and cryptographic requirements for ensuring the authenticity of the logo; and
- two obligatory safety features – a unique identifier (a two-dimensional barcode) and an anti-tampering device. The Commission Delegated Regulation (2016/161) describes the characteristics of the safety features and the procedures that govern the verification of their authenticity. Marketing authorisation holders must place these safety features on the outer packaging of most prescription medicines and certain non-prescription medicines no later than February 9 2019.