Q&A: enforcement of pharmaceutical product and medical system rules in Portugal
Regulation of pharmaceutical products and medical devices
What powers do the authorities have to monitor compliance with the rules on drugs and devices?
Infarmed has enforcement powers to inspect and supervise the activity of entities and of their respective products (namely medicines for human consumption, medical devices and cosmetics) and the performance of clinical trials.
Activities subject to inspection and supervision are the manufacturing, importing and exporting of medicines and medical devices; the wholesale distribution activity of medicines and medical devices; and the dispensation of the same to the public. Infarmed’s inspection unit handles inspection and supervision actions.
Entities such as manufacturers, market holders, wholesale distributors, pharmaceutical services of hospitals, pharmacies, and entities authorized to sell medicines not subject to medical prescriptions are subject to inspection and supervision activities. Manufacturing and wholesale distribution sites may be inspected, as well as head offices of market holders and distributors, the premises of pharmacies located in hospitals or those open to the general public, and entities authorized to sell medicines that are not subject to medical prescriptions.
Investigation time frames
How long do investigations typically take from initiation to completion? How are investigations started?
The law does not foresee a specific time frame for investigations. As such, time frames depend on the scope of an investigation and the related facts. However, an investigation report has to be concluded by Infarmed inspectors within 60 days following the end date of an inspection or visit. The inspected entity has 10 days, beginning from receiving notification of the report, to submit its reply in writing. Infarmed subsequently assesses the inspectors’ report and the inspected entity’s reply, whereupon it may issue an official report of administrative offense if an infringement is found.
Furthermore, specifically in relation to the wholesale distribution activities of medicines and medical devices, Infarmed’s inspection of wholesale distribution premises must be executed with the 30 days following its review of documentation submitted by an applicant requesting authorization to carry out wholesale distribution of medical devices, or when executing notification regarding the wholesale distribution of medical devices. If changes are required to premises, an applicant is granted an additional 30-day period to execute them.
Access to investigation materials
What rights or access does the subject of an investigation have to the government investigation files and materials?
Entities under investigation have access to the investigation report by Infarmed and, if applicable, to the official decision of administrative offense. In both cases, the defendant is entitled to the right of defense by means of a reply to the investigators’ report and opposition to the administrative offense preliminary decision. The defendants are entitled to challenge an administrative offense final decision by Infarmed before the competent court.
If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?
Infarmed may inspect, in conjunction with local authorities, facilities and establishments located in or outside the European Union, regarding the manufacturing of medicines, active substances or excipients, and also the laboratories committed to certain manufacturing phases or equipment authorized by Infarmed or used for the Manufacturing purposes foreseen in the Portuguese Human Medicine Act (PMA) approved by Decree Law No. 176/2006 of 30 August 2006, as amended.
In this regard, Infarmed may request the European Commission or a local agency, to subject manufacturers located in third countries to inspections.
Through what proceedings do agencies enforce the rules?
Infarmed is entitled to handle investigations, supervision and administrative offense procedures to enforce the applicable law. Final decisions adopted by Infarmed can always be subject to judicial review.
The proceedings are ruled by administrative law because they are not of a civil or criminal nature.
What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?
Besides the imposition of fines, Infarmed may also take decisions on the suspension, revocation or modification of the terms of a marketing authorization or register of a medicine, or on its withdrawal from the market or prohibition on its dispense whenever the medicine in question does not comply with the applicable law and regulations or does not meet the conditions of the respective authorization. Some contraventions are clarified in the PMA.
In the event of infringed legal provisions contained in the PMA, Infarmed can also impose violation fines and the following ancillary penalties:
- the seizure of objects, equipment and illegal devices by the state;
- a ban on a defaulter’s activities for a maximum two-year period;
- a ban on a defaulter from participating in public tenders for a maximum two-year period; other
- suspending authorizations, licenses or other titles granting rights for a maximum two-year period.
In the event of breaching the PMA legal provisions on publicity requirements of medicines reimbursed by the state, in addition to the administrative offense proceeding determined by such an infringement, the additional sanction of excluding the medicine from state reimbursement may also be imposed.
Regarding medical devices, Decree Law No. 145/2009 of 17 June 2009, as amended, which approves the Portuguese Medical Devices Act, authorizes Infarmed to impose corrective measures on breaches found in the course of an investigation and to impose fines for violations during the administrative offense procedure.
Sentencing and fines due to the violation of publicity and promotion laws on medicines and medical devices may also be published online and on social media, and a two-year suspension on the publicity and promotional claims on the product may be imposed.
Furthermore, breaching rules concerning medical sales representatives of medicines and medical devices visiting NHS healthcare units and services, and respective healthcare professionals, may lead to sales representatives and the respective market holder from being banned from accessing all such units and services.
Actions against employees
Can the authorities pursue actions against employees as well as the company itself?
The PMA is clear on this topic. It foresees that individuals, legal entities (regardless of the legality of incorporation), companies, and associations without a legal personality, may be responsible for administrative offenses arising from breaches of the PMA’s legal provisions when the facts were executed by the respective bodies during the performance of their duties.
The PMA also determines that members of such entities’ boards of directors may also be convicted by the sanctions applicable to the entity. Such sanctions may be attenuated, unless a more severe sanction is attributed by other legal provisions, if such a natural person was aware, or ought to have been aware, of the infraction, and did not adopt adequate measures to terminate the infringement immediately.
The PMA does not contain a similar provision as the one referred above for other employees. Therefore, as a rule, employees are excluded from Infarmed’s administrative offense proceedings. However, Infarmed may notify the relevant authorities and public prosecutors of infringements committed by the entities’ employees, depending on the nature of the infringement.
Defenses and appeals
What defenses and appeals are available to drug and device company defendants in an enforcement action?
Defendants’ procedural and due-process rights are secured in accordance with the applicable legal provisions of the General Regime on Administrative Offences, approved by Decree Law No. 433/82 of 14 September 1982, as amended.
Under this regime, no fines may be determined or applied by infarmed without the defendant being assured that it has the opportunity to provide its defense on the legal and factual reasoning on the alleged wrongful conduct and respective sanction.
From the outset, it is mandatory for Infarmed to notify the infringers or defendants of all decisions, dispatches and further measures it adopts. If such decisions and measures may be challenged, Infarmed’s notification must contain the necessary information on legal acceptability, terms and challenging form before the courts under the dual-tier judicial system.
Hence, decisions and measures taken in the course of an administrative proceeding may be challenged by the defendants before the competent court. Defendants may also try to obtain a suspension of enforcement of Infarmed’s administrative offense decisions taken by means of a protective measure submitted to the competent court and subsequently challenge the decision before the same court. First instance court decisions are subject to appeal.
What strategies should companies adopt to minimize their exposure to enforcement actions and reduce their liability once an enforcement action is under way?
In our view, such strategies should be focused on preventive measures such as defining and implementing strict compliance procedures for critical topics, such as pharmacovigilance, clinical trials, publicity, transparency relationships and interaction with healthcare professionals, as well as training and updating employees on the applicable law, regulation and on compliance procedures.
When an enforcement action is underway, cooperation with agencies is a legal requirement during the investigation phase and is recommended as it acts as a mitigating factor in terms of applicable sanctions. Grounded substantiated evidence that compliance procedures are implemented in the company to secure conformity with the law, subject to a case-by-case analysis, can also assist in mitigating applicable sanctions.
Recent enforcement activities
What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?
The main foci of Infarmed have been the supervision of pharmacovigilance and safety issues (namely concerning fake medicines and Covid-19 vaccines) and ensuring access to medicines. Information on applied sanctions is not publicly released on Infarmed’s website.
Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organizations police members’ conduct?
The most relevant industry bodies are the Portuguese Pharmaceutical Industry Association (Apifarma) and the Portuguese Association of Medical Devices Companies (Apormed).
Apifarma approved two codes of ethics:
- a code of ethics regarding the promotional practices of the pharmaceutical industry and for interactions with the healthcare professionals and institutions, organizations or healthcare professional associations; other
- a code of ethics regarding relations between the pharmaceutical industry and patient associations, patients advocates, patients experts, patients, and caregivers.
The implementation and enforcement of the codes are entrusted to Apifarma’s council of ethics, which, in the instance of a code violation, may ask the offender to immediately cease the violation or to promise, in writing, not to undertake such practices again. Violation of the codes’ provisions constitutes a disciplinary offense and may lead to disciplinary measures, such as:
- a simple warning;
- a written reprimand;
- a penalty up to the amount of five years’ membership fees;
- a suspension of up to one year; other
- an expulsion order.
Enforcement proceedings may be triggered by Apifarma or be based on a complaint.
In 2018, Apormed approved a Code of Good Commercial Practices, based on the MedTech Code of Ethical Business Practice. Apormed’s articles of association establish disciplinary sanctions applicable to the respective members in cases of infringement of the provisions of both the Code of Good Commercial Practices and Apormed’s Articles of Association, which are the following:
- a simple warning;
- a written reprimand;
- a penalty up to double the amount of the highest membership fee;
- a suspension of the associate for between one and six months; other