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Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

The Federal Agency for Medicines and Health Products created a working group to assist in the implementation of a Royal Decree on biobanks (9 January 2018). The group created a compendium for health professionals, who are the subject of the new regulation.

On 7 May 2018 the agency launched an online database containing information on all clinical trials approved in Belgium, as well as pending trials.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The key legislation governing medicines in Belgium includes:

An overview of Belgian royal and ministerial decrees governing medicines can be found here.

The key legislation governing medical devices is derived from EU legislation, including:

Additional Belgian legislation governing medical devices can be found here.

Are any legislative changes proposed or expected in the near future?

On 8 June 2016 the European Union adopted the EU Trade Secrets Directive. EU member states had to bring into force national laws to comply with the directive by 9 June 2018.

On 16 June 2014 Regulation 536/2014 on clinical trials on medicinal products for human use entered into force. However, the timing of its application depends on the development of a fully functional EU clinical trials portal and database. The entry into application of the regulation is estimated to occur in 2019.

The EU Regulation on Medical Devices (2017/745) and the EU Regulation 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.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The Belgian national agency competent for governing medicinal products is the Federal Agency for Medicines and Health Products. The agency ensures, from development to use, the quality, safety and efficacy of medicines and health products for human and veterinary use, including medical devices and raw materials for the preparation and production of medicines.

The agency has the following competencies:

  • Research and development – the agency evaluates, approves, follows and controls requests for clinical trials for medicines and health products, as well as giving scientific advice.
  • Registration or marketing authorisation of medicine – the agency is in charge of evaluating new requests for registration or marketing authorisation of a medicine or of requests to change existing registrations or marketing authorisations.
  • Vigilance – the agency supervises adverse effects due to the use of medicines or health products by collecting information. Information is gathered and evaluated and, if necessary, measures are taken.
  • Production and distribution – the agency grants authorisations and checks that medicines and health products conform with existing regulations concerning manufacture, distribution, delivery, imports and exports. It also controls pharmacists’ activities and combats illegal practices.
  • Proper use – the agency ensures that patients have the relevant information, so that medicines and health products are used rationally and safely. It also controls advertising for medicines and health products.

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. In addition, the laws protecting IP rights and compliance are key.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

The Law on Medicines (25 March 1964) contains a narrow definition of ‘medicines’. In particular, a difference can be noted between the EU Directive 65/65/EEC and the Belgian law regarding the administering criteria. This has, for example, resulted in a ruling of the Brussels Court of Appeal stating that appetite suppressant drugs are not medicines.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

Manufacturers of medicines or intermediary products in Belgian territory must file an application to the Federal Agency for Medicines and Health Products to obtain authorisation. The manufacturing licence is delivered by the minister or a representative.

Authorisation is also required in case of a total or partial manufacture and for work such as dividing, packaging or presentation.

What is the fee for obtaining authorisation?

The fee that must be paid for obtaining authorisation depends on the activities of the applicant and whether the place of the activities is subject to inspection by the Federal Agency for Medicines and Health Products. The fees are listed on the agency’s website.

What is the validity period for authorisation?

Manufacturer licences remain in force until they are:

  • revoked by the Federal Agency for Medicines and Health Products; or
  • surrendered by the licence holder.

How robust are the standard good manufacturing practices followed in your jurisdiction?

Standard good manufacturing practices are robust in Belgium. For export, registration and tenders, the minister or a representative may certify on request that a pharmaceutical product was manufactured pursuant to the standards of good manufacturing practice. These certificates are issued pursuant to the applicable administrative guidelines of the World Health Organisation.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Failure to obtain manufacturing authorisation or follow good manufacturing practices can result in a criminal offence. The penalties can be found in the Law on Medicines (25 March 1964). 

Distribution

How are the distribution and storage of medicinal products regulated?

The Federal Agency for Medicines and Health Products and the European Medicines Agency have published guidance on good distribution practice. The guidance is applicable to wholesale distribution authorisation holders of medicinal products, as well as to manufacture authorisation holders involved in distribution activities, including storage. A specific working group has been set up by the Federal Agency for Medicines and Health Products to answer questions and clarify interpretation that may arise with the revised guidelines of 7 March 2013.

Import and export

How are the import and export of medicinal products regulated?

Both the import and export of medicinal products are subject to authorisation. The application must be made to the Federal Agency for Medicines and Health Products and involves a fee.

In addition, medicines which have not received marketing authorisation in Belgium or another member state can be exported as long as a declaration for export is obtained from the minister or a representative (the agency’s chief executive officer).

Are parallel imports permitted in your jurisdiction?

Yes, medicines sold in Belgium or another member state can be imported by a company from that member state as long as certain legal requirements are met. Such parallel import is in line with the European principle of ‘free circulation of goods’ and is in principle applicable in all member states.

Although European legislation does not stipulate that the composition of the imported medicine must be 100% identical to the medicine that is acting as the reference point, the qualitative and quantitative composition in terms of the active substance must be the same and the imported medicine must have the same therapeutic effect as the reference medicine.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

To place a pharmaceutical product on the Belgian market, the product must have a valid authorisation obtained either from the European Medicines Agency or the Federal Agency for Medicines and Health Products.

The Mutual Recognition and Decentralised procedures are European authorisation procedures based on the principle of recognition of the evaluation of the reference member state by the other member states. If there are objections to placing the pharmaceutical product on the market due to a potential high risk to public health, the procedure will be referred to the coordination group of the Mutual Recognition and Decentralised procedure.

Are there any restrictions on the online sale and purchase of medicinal products?

Only licensed and publicly available pharmacies can, under strict conditions, sell medicines online for human use without a prescription, as well as certain medical devices (eg, condoms and bandages). The websites of these pharmacies must be notified to the Federal Agency for Medicines and Health Products and the Order of Pharmacies.

Online purchasing of pharmaceutical products that require a medical prescription in Belgium, are not licensed or are the subject of special legislation, is prohibited and can lead to penalties and the seizure of the products.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

A positive evaluation is necessary from both an ethical committee and the Commission for Medicines for Human Use – an entity within the Federal Agency for Medicines and Health products – and for pre-launch access in case a compassionate use programme or medical need programme are established.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Clinical trials can commence only after receiving a favourable opinion from the Ethics Committee and if the Federal Agency for Medicines and Health Products has not indicated any major insufficiency within the legal timeframe provided for in the Law on Experiments on Humans (7 May 2004). An application must be submitted to the agency and be accompanied by payment of a fee.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Standard good clinical practices are robust in Belgium. The Federal Agency for Medicines and Health Products’ medicinal product database gathers information about all medicinal products authorised in Belgium, as well as a link to relevant documents (eg, the patient information leaflet, the Summary of Product Characteristics, the Risk Minimisation Activities and the Dear Healthcare Professional Communication). The information allows for a safe and correct prescription, delivery and use of medicinal products.

In order to encourage a rational use of medicines, it is vital for healthcare professionals to be able to count on information that is objective, recent, easily accessible and respecting the principle of medicines based on proof.  In view of this the agency has formed a partnership with independent organisations that provide objective information about medicines. In this way the expectations of healthcare professionals in terms of quality and accessibility of information are taken into account.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The investigator is obliged to immediately report all serious adverse events to the clinical trial sponsor, except for those serious adverse events for which the protocol or investigator's brochure does not require immediate reporting. For reported deaths, the investigator should provide the clinical trial sponsor and recognised ethics committee with any additional information requested.

The clinical trial sponsor should keep a detailed record of all adverse events reported by the investigators. These records should be forwarded to the minister at his or her request when the experiment is conducted in Belgium (Article 27).

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 full details of the trial’s nature, scope, implications, expected benefits and risks of the experiment, as well as the circumstances wherein the experiment takes place. This information should be provided in writing in a clear and understandable way. Subjects participating in an experiment can revoke their consent without it causing them any disadvantages. Consent must be evidenced in writing. Specific rules apply concerning consent in relation to minors and adults that are incapable of granting their consent participating in an experiment (Article 6).

Insurance

What are the insurance requirements for clinical trials?

Before the start of an experiment, the sponsor of the clinical trial must have in place an insurance policy covering its liability and that of any person involved in the experiment, regardless of the link between the intervener, clinical trial sponsor and participants.

The sponsor or a legal representative of the sponsor must be established in the European Union (Article 29).

Data protection

What data protection issues should be considered when conducting clinical trials?

The EU 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 – 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 – 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 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 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 GDPR outlines certain safeguards that are likely to be present in most clinical research.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

Only medicinal products that have a valid marketing authorisation in Belgium may be the subject of advertising.

Some means of dissemination are not allowed for an advertisement for a medicinal product, for example:

  • signs on the motorway (except for nicotine-based medicines against dependence on smoking);
  • telephone, direct mail or email;
  • publications for children; and
  • objects of any kind to be used, partially or totally, for any purpose other than to communicate information.

Advertising for general publicOnly medicinal products that are not subject to prescription can be the subject of advertising to the public. Such advertising is subject to prior control before its release:

  • Advertising broadcasts on radio or television must obtain prior approval granted by the minister of public health, on notice from the Commission for the Control of Medicinal Product Advertising.
  • Advertising broadcasts on other media must be notified to the Federal Agency for Medicines and Health Products at least 30 days before publication.

All advertising to doctors, pharmacists and dentists must conform to the summary of product characteristics and the elements of the case accepted with the marketing authorisation.

If the advertisement is written, it should include, on at least half of its surface area, some scientific information extracted from the summary of product characteristics.

What criteria are considered in granting marketing authorisation?

Advertising is always prohibited for:

  • unauthorised medicines;
  • banned medicines; and
  • suspended medicines.

Advertising is prohibited to the general public for:

  • medicines that can be obtained only with a medical prescription; and
  • narcotics and psychotropics.

Medicines that may be advertised to the general public are as follows:

Medicinal products according to their composition and purpose that are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

Advertising to the public may be inappropriate for non-prescription medicines but not those designed for treatment initiated by self-medication without preliminary diagnosis by a doctor.

What is the fee for obtaining marketing authorisation?

The fees for obtaining market authorisation are listed on the Federal Agency for Medicines and Health Products website.

What is the validity period for marketing authorisation?

Marketing authorisations must be renewed on a biennial basis.

What are the consequences of failure to obtain marketing authorisation?

The Law on Medicines (25 March 1964) and the Royal Decree (7 April 1995) provide for a set of penalties when failing to obtain market authorisation.

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

Healthcare professionals Healthcare professionals (eg, doctors, pharmacists and dentists) can inform the Belgian Centre for Pharmacovigilance for Medicines for Human Use through the ‘yellow card’ system regarding any suspicion that they have concerning adverse effects of medicines which they come across in daily practice.

It is particularly important to report the following situations:

  • Serious adverse effects – adverse effects that have led to hospitalisation or prolongation of hospitalisation, that have been life-threatening or have caused death, permanent or significant disability or inability to work, or congenital disorder or malformation.
  • Unexpected adverse effects – adverse effects of which the nature, seriousness and the evolution do not correspond with the summary of product characteristics.
  • Suspected adverse effects – adverse effects that are known but of which the frequency, seriousness or result is abnormal.
  • Adverse effects occurring in the following situations:
    • vulnerable populations (eg, children, pregnant or breastfeeding women, the elderly and patients with hepatic of renal failure);
    • administration of vaccines;
    • switching from one specialty to another during treatment, regardless of whether it concerns the switch between original medicines, from a generic to an original medicine, from an original to a generic medicine or between generic medicines; and
    • inappropriate or off-label use of a medicine.

It is also important to report any adverse effects of so-called ‘black triangle drugs’. These include medicines that contain a new active substance and new biological medicines. They are indicated by the symbol ▼ in the Répertoire Commenté des Medicaments. The ▼ symbol appears for the first three years after the medicine in marketed.

It is important that these ▼ medicines are followed closely as soon as they are marketed. At the time that a medicine is authorised, knowledge about its adverse effects is still limited. The clinical studies conducted for marketing authorisation are mainly intended to show the efficacy of the medicine and have limitations in detecting adverse effects:

  • the number of patients included in the studies is usually too low to detect rare adverse effects;
  • the duration of the studies is not long enough to detect adverse effects that appear at a later stage; and
  • the studies do not usually include patients that present a high risk of adverse effects (eg, paediatric or elderly patients, patients with important comorbidity or polymedication, and patients with kidney and liver failure).

The Belgian Centre for Pharmacovigilance for Medicines for Human Use requests that healthcare professionals report any suspicions they may have of adverse effects – serious and non-serious – with ▼ medicines, even when there is some doubt about causality.

Healthcare professionals are encouraged to report all adverse effects that they consider medically significant, even if they do not meet the abovementioned criteria.

The causality between the suspected medicine and the adverse effect should not necessarily be established to report.

PatientsPatients experiencing an adverse effect after taking a medicine are recommended to contact their doctor, pharmacist or dentist who will fill in the reporting form.

Marketing authorisation holdersMarketing authorisation holders who are informed about a serious adverse effect by healthcare professionals, investigators for clinical trials or scientific publications, must report this to the Belgian Centre for Pharmacovigilance for Medicines for Human Use within 15 days of receipt of the information. In this context, a ‘serious adverse effect’ is defined as an adverse effect that:            

  • causes hospitalisation or prolongation of hospitalisation;
  • is life-threatening;
  • causes death;
  • leads to permanent or significant disability or inability to work; and
  • causes a congenital disorder or malformation.

Data protection

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 EU General Data Protection Regulation (GDPR) considers obtaining a 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 the quality and safety of healthcare and of medicinal products or medical devices, on the basis of EU law or member state law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subjects (eg, professional secrecy).

Under Article 17(1) of 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

Pricing Reimbursement

What is the structure for state reimbursement of medicinal product costs?

Yes, the following rules govern the pricing of medicinal products:

  • Regarding new or existing reimbursable medicines, applications for pricing or price increases must be submitted to the Federal Public Service Economy. The minister of economy makes a decision after obtaining advice from the Price Commission for Pharmaceutical Specialties. Parallel to the pricing procedure, a procedure regarding the adoption of reimbursement is ongoing at the Commission for Reimbursement of Medicinal Products. However, when submitting an application for a price increase, the aforementioned procedures are sequential.
  • Regarding non-refundable medicines, prescription-free treatments or medicines where at least one form is subject to a doctor's prescription, applications concerning price increases or determinations must also be submitted to the Federal Public Service Economy. The minister will decide after consulting the permanent committee of the Pricing Committee. 

Are there rules governing the pricing of medicinal products in your jurisdiction?

Health insurance will reimburse a medicine if it meets the following conditions:

  • the pharmacist receives a prescription drawn up by a general practitioner, specialist, dentist or midwife;
  • the pharmacist delivers the medicines;
  • the medicine is on one of the lists of medicines for which a reimbursement is foreseen; and
  • the reimbursement conditions are respected.

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

Advertising of medicinal products to healthcare professionals must contain essential information, including, among other things, the name of the medicinal product, its qualitative and quantitative composition in terms of active ingredients and its pharmaceutical form (Article 9).

Advertising of medicinal products to the general public is prohibited if the medicinal product has not been registered. Additional restrictions on the advertising of medicinal products to the general public are described in the Law on Medicines (25 March 1964).

Do any special rules apply to online advertising of medicinal products?

In principle, any medicinal product or medicinal device must be delivered personally to the patient in the pharmacy. However, licensed and publicly available pharmacies can, under strict conditions, sell medicines online for human use without a medical prescription and certain medical devices (eg, condoms and bandages). The websites of these pharmacies must be notified to the Federal Agency for Medicines and Health Products and the Order of Pharmacies.

Labelling

What are the packaging and labelling requirements for medicinal products?

The Law on Medicines (24 March 1964) provides for the following packaging and labelling requirements:

  • the packaging leaflet should be designed and written in clear, comprehensible language to enable the user, if necessary with the assistance of healthcare professionals, to make appropriate use of the medicinal product; and
  • the particulars mentioned in the packaging leaflet and those mentioned on the outer or immediate packaging of any medicinal product to be placed on the market must be drawn up in the three national languages.

Failure to respect the packaging and labelling requirements can result in a criminal offence. The penalties can be found in the Law on Medicines (Article 16).

How is the promotion of off-label use regulated?

Off-label use requires informed consent of the patient. Healthcare professionals have the therapeutic freedom to prescribe drugs off-label. However, they should carefully consider this use, based on scientific evidence, among other things. In addition, they should inform the patient in advance about the off-label use and possible associated risks.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

Healthcare professionals are not allowed to accept donations from a patient that they have treated who is still alive or who dies as a result of the disease for which the healthcare professional was treating them (Article 909 BW). The same applies to professionals working in nursing and retirement homes. In addition, it is forbidden when prescribing, providing, supplying or administering medicinal products to promise, offer or grant, directly or indirectly, premiums or monetary advantages or benefits in kind to persons qualified to prescribe, dispense or administer medicinal products and to the institutions in which the prescribing, dispensing or administering of medicinal products take place. 

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Claimants have five years to bring a claim for personal injury from the date of knowledge of the damage or its aggravation and knowledge of the identity of the liable individual.

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.

For a contractual claim, the limitation period is 10 years from the day on which the manufacturer brought the product to the market, unless during that period the victim initiated legal proceedings. However, the claimant has only three years to bring a contractual claim from the day on which he or she should reasonably have been aware of it (Article 12).

Which parties can be held liable for a defective medicinal product?

Pharmacists and manufacturers can be held liable for a defective medicinal product.

Each pharmacist is responsible for the pharmaceutical actions that he or she performs or supervises, including pharmaceutical care, advice and information. Each pharmacist is also responsible for the conformity and quality of what he or she delivers and prepares (Article 2).

The manufacturer's liability towards the victim cannot be excluded or limited by contract. It may be excluded or limited where the damage is caused, both by a defect in the product and by the fault of the victim or of a person for whom the victim is responsible.

Remedies

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.
  • Damages are also 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.

Exclusion and limitation

On what grounds can liability be excluded?

The manufacturer's liability towards the victim cannot be excluded or limited by contract. It may be excluded or limited where the damage is caused, both by a defect in the product and by the fault of the victim or of a person for whom the victim is responsible.

The manufacturer is therefore liable unless it proves that:

  • it did not put the product on the market;
  • it is likely, considering the circumstances, that the defect which caused the damage did not exist when the manufacturer brought the product to the market or that the defect occurred subsequently;
  • the product was not manufactured for sale or for any other form of distribution with an economic purpose by the producer, nor was it manufactured or distributed in the course of the manufacturer’s trade;
  • the defect is due to the fact that the product complies with mandatory government regulations;
  • the state of scientific and technical knowledge, at the time when the manufacturer brought the product to the market, made it impossible to detect the existence of the defect; and
  • in the case of the manufacturer of a component part or raw material, the defect is due to the design of the product of which the component part or raw material forms a part, or to the instructions given by the manufacturer of that product (Article 8).

What preventive steps can be taken to limit liability?

Ensuring terms and conditions or sale and purchase contracts are drafted containing proper warranties and indemnities.

Compliance and enforcement

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 658/2007). In Belgium, the Federal Agency for Medicines and Health Products exercises its enforcement powers based on the Law on Medicines (25 March 1964).

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

Healthcare professionals are not allowed to accept donations from any patient that they have treated who is still alive or who dies as a result of the disease for which the healthcare professional was treating them. The same applies to professionals working in nursing and retirement homes.

When prescribing, providing, supplying or administering medicinal products, it is forbidden to promise, offer or grant, directly or indirectly, premiums or monetary advantages or benefits in kind to persons qualified to prescribe, dispense or administer medicinal products and to the institutions in which the prescribing, dispensing or administering of medicinal products take place.

The Federal Agency for Medicines and Health Products has a special unit (ie, the Special Investigation Unit) that tackles issues of counterfeiting (ie, bringing non-conforming products to the market) and fraud. This unit intervenes at all levels of the chain and cooperates with other inspectors, various judicial authorities and other competent authorities to carry out its tasks.