The Portuguese life sciences sector, in which the pharmaceutical industry and wholesale distribution players have an important role and share, has significantly grown in recent years. This growth in business volume has been largely driven by the diversity of products available on the market including innovative medicines, particularly biological products, innovative medical devices, and health technologies.

Portuguese start-ups have emerged and contributed to market growth with innovative solutions:

Universities also have a key role in health research and development (R&D), although Portuguese R&D has not reached the level of other EU countries.

The pharmaceuticals industry, notably the big pharma companies, continue to dominate the local market and are quite active in reshaping business activity, particularly through spin-offs of specific business areas and mergers and acquisitions. There is no available public information on recent transactions.

The interaction between the industry and the National Health Service (Serviço Nacional de Saúde) (SNS) is substantial. As the main health care provider in Portugal, the SNS is the industry's biggest client. However, this interaction is subject to strict supply rules in the form of tendering and public procurement procedures. Pharmaceutical companies' advertising, promotional activities, and provision to SNS hospitals and health care providers are also strictly regulated.

Since 2018, Portugal has been prominent in the medical cannabis field and related activities including the cultivation and manufacture of medical cannabis products. Investment in medical cannabis is quite substantial, due to:

The life sciences funding is not specific to the sector. Therefore, companies are financed by equity with variable financing rates and source the remaining financing through the common means of financing economic activities. Therefore, in addition to capital increases by existing shareholders or by opening the share capital to new shareholders, companies obtain financing from banks or by issuing bonds.

Sometimes public support, either national or from the EU, is made available to finance research initiatives.

The SNS comprises all the public services and units that provide health care services, including:

The Portuguese Autonomous Regions of Madeira and Azores have a specific Regional Health Service, which is locally supervised and monitored by specific regional entities.

The Statute of the SNS is contained in Decree-Law No. 52/2022, 4 August 2022 (in Portuguese). The SNS is governed at central level by an executive board.

The SNS is funded through the state annual budget and by moderating fees paid by users. The SNS also includes a centralised procurement system for hospitals for the purchase of medical products, through the Central Purchasing Authority of the Shared Services of the Ministry of Health (Serviços Partilhados do Ministério da Saúde (SPMS)). The procurement for the purchase of medical products in the Portuguese Autonomous Regions is centralised by local designated entities.

The SNS also has arrangements with private providers for the delivery of designated diagnostic and therapeutic services.

Pharmaceutical companies interact with health care professionals serving the health care system through:

In addition to these interactions, the life sciences industry has a commercial relationship with the healthcare system, as healthcare providers are among the main purchasers of the products sold by the life sciences industry.

Public and private healthcare providers receiving public funding are subject to public procurement rules. This means that the procurement of products sold by the life sciences industry must follow the strict procedures laid down by law (mainly in the Public Procurement Code, approved by Decree-Law No 18/2008 of 29 January, as amended (in Portuguese). As a rule, these procurement procedures must be competitive procedures (that is, procedures open to market competition).

Some of the medicines purchased by the hospitals of the NHS services and institutions or bodies and services of the Ministry of Health are to be purchased through centralised procurement procedures leading to the conclusion of framework agreements. Centralised purchasing procedures are conducted by the SPMS.

Decree-Law No. 97/2015 of 1 June 2015 sets out specific price regimes for the different types of medicines, distinguishing the outpatient market from the hospital market (SNS hospitals), as follows.

Outpatient market. Ministry of Health Order no. 195-C/2015 of 30 June 2015 sets out the price of medicines determined in accordance with a maximum price mechanism for:

These prices are determined through a comparison with the approved wholesaler prices (PVA) in referenced countries for the same medicine, or for an identical pharmaceutical with the same active substance, pharmaceutical formula, and dosage.

The price of generic medicines is obtained by a comparison with a reference medicine with the same dosage, and must be:

The maximum price of parallel imported medicines must be at least 5% less than the maximum retail price approved for that medicine and for the identical and similar medicines that hold a marketing authorisation in Portugal.

Non-reimbursed medicines subject to medical prescription that already have a maximum retail price can be modified under the notification price regime. The market authorisation holder can notify the National Authority of Medicines and Health Products, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde) (INFARMED) that it intends to market the medicine at a higher retail price. INFARMED can oppose the intended price. If INFARMED fails to oppose it, the market authorisation holder's notified price is considered tacitly approved.

Hospital market. Non-reimbursed medicines subject to medical prescription to be purchased by SNS units and services are subject to a specific prior evaluation procedure. As a result, the supply conditions and maximum price of these medicines is regulated in a written contract between the medicine market authorisation holder and INFARMED. However, the maximum acquisition price of these medicines cannot exceed either:

The prior evaluation procedure may also apply to other medicines, if the respective sales volume with SNS entities and services is significant. The maximum acquisition price of generic medicines to be purchased by SNS units and services is also determined in accordance with the maximum price mechanism.

Reimbursed medicines. The price of both prescription and over-the-counter (OTC) medicines eligible for reimbursement by the SNS is subject to the reference price mechanism, when these medicines are included in homogeneous groups of medicines. The reference price for each homogeneous group of medicines corresponds to the average of the five lowest retail prices of the medicines that make up each homogeneous group. The reference countries are subject to a yearly review by the Minister of Health.

In a specific homogeneous group, the maximum retail price of new medicines to be reimbursed should be at least 5% less than the generic medicine that has the lowest price and has at least a 5% market share of generic medicines in the homogeneous group.

The maximum prices are subject to annual revisions, on the basis of a comparison with prices approved in the reference countries. Exceptional reductions may also occur under a specific order issued by the Ministry of Health, due to a need to regularise the relevant market.

The price of OTC medicines that are not subject to reimbursement by the SNS is not regulated by the public authorities.

Decree-Law No. 97/2015 provides that certain medical devices or generic groups of medical devices for SNS users can be subject to a maximum prices special regime, which is to be defined by specific orders issued by the Ministry of Health. In addition, certain devices can also be subject to a maximum acquisition price by SNS entities, through a prior evaluation contract with the market authorisation holder or distributor.

The cost of a medicinal product can be funded by the state on the basis of either:

(Decree-Law No. 97/2015.)

The scientific and economic assessment for funding by the SNS is carried out by INFARMED. Medicines that receive upfront reimbursement of the pharmacy sale price by the SNS generally fall within one of four rating bands:

(Order no. 195-D/2015, 30 June 2015.)

Order no. 195-D/2015, 30 June 2015 specifies the pharmacotherapeutic groups and subgroups included in each of the scales.

Decree-Law 97/2015 also establishes that special funding and reimbursement regimes apply:

A pharmacist in a dispensing pharmacy is remunerated through a maximum legal margin on the reimbursed medicines not subject to medical prescription and on medicines subject to medical prescription (reimbursed or not), based on the approved medicine authorised wholesale price (MAWP). The pharmacist's price margin varies according to the MAWP price, as follows:

(Order no. 195-C/2015.)

Pharmacies can also obtain a specific additional remuneration of EUR0.35 per medicine package, provided that they meet the applicable conditions under Order no. 262/2016, 7 October 2016. For each pack of medicines dispensed at a price equal to or lower than the 4th lowest price of the homogeneous group of medicines (group of medicinal products with the same qualitative and quantitative composition in active substances, dosage, and route of administration, with the same or equivalent pharmaceutical form, in which at least one generic medicinal product on the market is included), the pharmacy is remunerated by EUR0.35.

Prescription medicines and OTC medicines reimbursed by the SNS are exclusively sold in pharmacies. OTC medicines not subject to reimbursement by the SNS can be sold by OTC retailers (parafarmácias).

The home delivery of medicinal products is allowed by:

(Order 1427/2007, 2 December 2007.)

Home delivery must be provided in the geographic municipality where the pharmacy or OTC retailer is located and in the surrounding geographic municipalities.

Orders by patients can be placed through any of the following methods:

Pharmacies are governed by the rules of Decree-Law No. 307/2007, 31 August 2007. OTC medicine retailers are governed by Decree-Law No. 134/2005, 16 August 2005.

Wholesale distribution activity is defined by the Medicines Act (approved by Decree-Law No. 176/2006, 30 August 2006) as the activity of supplying, holding, storing, or supplying medicinal products for processing, reselling, or use in medical services, health units, and pharmacies, excluding supply to the public.

Wholesale distribution can be carried out:

Wholesale distributers and logistic operators must be authorised by INFARMED. Wholesale distribution applications to INFARMED must include:

After verifying the submission meets the application criteria, INFARMED proceeds, within a maximum period of 30 days, to the inspection of the premises where the applicant intends to conduct the activity and issues its decision within 30 days.

The authorisation specifies the distribution activities the entity is authorised to perform and identifies the respective warehouse facilities.

Wholesale distributors require:

Among other obligations, wholesale distributors must comply with good distribution practices (GDP).

Marketing authorisation holders or their local representatives are exempted from the wholesale distribution authorisation. They must register their distribution activity with INFARMED. Registration is a simpler procedure. Registration applications are submitted electronically and must include:

Manufacturers of medicinal products duly licensed by INFARMED are exempt from obtaining wholesale distribution authorisation for medicinal products they have manufactured.

INFARMED exercises regulatory, supervisory, and sanctioning powers. INFARMED:

The import of medicinal products is subject to INFARMED's prior authorisation.

Each batch of imported medicinal products, including those manufactured but not controlled or released in a EU member state, must undergo:

It is the responsibility of the importer to ensure that medicinal products and investigational medicinal products imported from third countries have been manufactured:

Medicinal products imported from countries with which the EU has concluded treaties that have the effect of waiving the requirement for a national import authorisation do not require authorisation.

Parallel imports of medicinal products are permitted provided the following conditions are met:

The conditions set out in the second and fourth bullet points above are presumed to be verified if:

A parallel import is subject to a prior authorisation procedure that requires the submission of a specific form and documents. The authorisation must be granted by INFARMED within 45 days, if this time period is not suspended due to pending clarification requests or additional submission of documents.

In addition to complying with the generic labelling requirements (applicable to all medicinal products to be marketed in Portugal), parallel imported medicinal products must be labelled with:

Intellectual property rights cannot be used to oppose parallel imports.

The advertising of medicinal products is governed by:

INFARMED is responsible for the supervision and enforcement of the provisions on advertising to health care professionals and the general public. In this context, INFARMED issues administrative regulations on specific topics on the advertising of medical products.

The Portuguese Pharmaceutical Industry Association (Associação Portuguesa da Indústria Farmacêutica) (APIFARMA) has approved the following codes, which bind pharmaceutical companies that are APIFARMA members:

The Medicines Act defines advertisement of medicines as any form of information, prospecting, or incentive which is within the scope of, or has the effect of, promoting the prescription, dispensation, sale, acquisition, or consumption of medicines in any of the following circumstances:

The advertising regulations do not apply to:

Medicinal product marketing authorisation holders must:

The scientific service must ensure that:

Scientific service records must be available for INFARMED to consult or inspect.

No other internal procedures or approvals are mandatory.

Pharmaceutical advertising does not require INFARMED's approval, except in cases involving vaccination campaigns or promotional campaigns for generics aimed at the general public. These adverts must be approved by INFARMED or the campaigns can be classified as prohibited advertising activity.

Marketing authorisation holders or holders of medicinal products registers must submit one sample of each advertising material concerning each product, for information purposes, to INFARMED within ten days of its issue. (Holders of registrations for medicinal products are those entities subject to simplified registration procedures (for example, some homeopathic medicinal products or some herbal medicinal products) and, eventually, holders of registrations for medicinal products that have centralised marketing authorisations.)

Comparative advertising of medicines can only be directed at health care professionals. Comparative advertising to the general public is prohibited.

APIFARMA’s Code of Ethics states that comparative advertising should be based on relevant and comparable aspects. It cannot be misleading or defamatory and the comparison of medicinal products should be limited to the product characteristic specifications, instructions for use, technical documents, or credible clinical data.

Advertising of unauthorised medicinal products or of unlicensed indications is prohibited.

However, certain information is not classified as advertising, for example, price and product lists (see Question 10). Information on human health or diseases is also not classified as advertising if there is no direct or indirect reference to or mention of a specific medicinal product.

APIFARMA’s Code of Ethics states that the pharmaceutical industry can disclose advances in medicinal products and therapeutics and the results of scientific research they are carrying out to the scientific community.

The general rules applicable to advertising medicines in the Medicines Act apply to advertising medicines thorough the internet and social media.

INFARMED has issued two Informative Circulars (Informative Circular no. 229/CD, of 9 November 2011 and Informative Circular no. 236/CD of 16 November 2011) establishing specific rules on advertising through the internet and other digital channels. Pharmaceutical companies can advertise their prescription-only medicines to the general public, whether or not they are reimbursed if:

Healthcare professionals' access to advertisements for pharmaceuticals via the internet or social media follows the general rules for advertising to healthcare professionals. The content made available to healthcare professionals through these channels should not be accessible to the general public (and cannot under the law be made available to the general public).

INFARMED can impose fines for any infringement of the Medicines Act provisions, including those relating to advertising. The fines, per infringement, range from EUR2,000 to 15% of the business volume of the infringer or EUR180,000, whichever is lower.

Depending on the seriousness of the infraction and the level of fault, INFARMED can also impose:

INFARMED can also punish the infringement of advertising legal provisions by:

Infringements of APIFARMA’s code provisions on advertising and inducement to prescribe and consume medicinal products are dealt with by APIFARMA’s Ethics Council, which can impose the following penalties on members:

Certain medicines cannot be promoted or advertised to the general public, only to health care professionals (for example, doctors, pharmacists, and nurses). They must be advertised in scientific publications or other forms of communication with use restricted to health professionals. These medicines include:

Over-the-counter (OTC) medicines can be advertised to the general public.

The advertising of all of the above categories of medicinal products must:

Any advertisement to the general public of an OTC medicine must:

The advertising of a medicinal product to the general public must not contain any material that:

Advertising to persons qualified to prescribe or supply medicinal products must include the following:

Measures or commercial practices related to margins, prices, and discounts are not subject to the advertising rules of the Medicines Act.

The provision of free samples to the public is not permitted.

In addition, pharmaceutical companies, companies responsible for the promotion of medicines, and wholesale distributors cannot give or promise to give, directly or indirectly, to the general public prizes, gifts, bonuses, or pecuniary or in-kind benefits.

Pharmaceutical companies can, as a general principle, interact with patient organisations. There are no prohibitions in the Medicines Act.

APIFARMA’s Code of Conduct expressly mentions the following activities:

APIFARMA’s Code of Conduct contains several rules on these interactions:

Health care professional is defined in the Medicines Act as a person legally qualified to prescribe, dispense, or administer medicines, namely physicians, dentists, veterinary surgeons, odontologists, pharmacists, or nurses. No definition of a health care organisation is provided by Portuguese law.

Advertisements to health care professionals must include, in a legible way:

(Article 3(1)(jjj) and Article 154(2), Medicines Act, respectively.)

Marketing authorisation holders, companies responsible for the promotion of medicines, and distributors cannot offer or promise to offer, directly or indirectly, to health professionals or to patients any gifts, bonuses, or pecuniary or non-pecuniary benefits, unless the offer relates to an object relevant to the practice of medicine and is of insignificant economic value (Article 158(1), Medicines Act).

The sponsoring of scientific promotions addressed to health professionals, and consultancy agreements engaging health professionals, are allowed provided payments are not conditional on the prescription or dispensing of medicines. Event promoters can provide health professionals with travel and attendance expenses for their participation in scientific and promotional events, as speakers or consultants, subject to certain requirements.

Decree-Law No. 5/2017, 6 January 2017, established a new set of rules on publicity and transparency. One of the most relevant restrictions is the prohibition on SNS hospitals or Ministry of Health bodies and services receiving benefits from pharmaceutical or medical devices companies unless previously authorised by the Ministry of Health. In addition, scientific or similar actions of pharmaceutical companies cannot be conducted at SNS hospitals or services premises. Scientific actions in SNS facilities cannot:

Anti-bribery legislation also applies to the life sciences sector, notably when dealing with public officials and state institutions.

The following provisions can apply:

Penalties can include imprisonment and fines for representatives of the company, public officials, and other third parties for committing certain offences.

Portuguese anti-bribery provisions can apply to offences occurring outside Portugal, but exceptions may apply.

Marketing authorisation holders or their local representatives must report benefits of EUR60 or above, granted to health care professionals, health care organisations, or patient organisations.

These benefits must be reported to INFARMED’s transparency platform 30 working days from the effectiveness of the benefit (payment of the benefit or granting of the benefit in cases of granting of benefits in kind or of rights assessable in cash).

Benefits are defined in Medicines Act as any advantage, value, good, or right assessable in cash, regardless of its form, whether it is a prize, sponsorship, subsidy, fee, subvention, or any other form.

INFARMED notifies the recipient by email and requires them to validate the reported information. If the recipient does not validate the reported information, they must inform INFARMED of their reasons. If the recipient remains silent on the reported information, it is considered tacitly accepted.

There is no distinction between public and private providers.

There are no consequences specific to non-compliance with the rules on marketing to health care professionals. The penalties in Question 16 apply.

The Portuguese law does not provide a definition of patent. However, patent is defined in jurisprudence as “legal title that can be granted to any invention of a technical nature, provided that it is new, involves an inventive step, and is susceptible of industrial application” (Judgment of Lisbon Court of Appeal of 28 June 2018, proc. 108/16.0YHLSB.L1-2).

Patents are governed by the Industrial Property Act (Decree-Law No. 110/2018, 10 December 2018 (in Portuguese)).

A patent is granted to an invention, in all fields of technology, provided it:

Patents can protect:

New processes for obtaining known products, substances, or compositions can also be patented.

If a patent concerns a process, the rights conferred by it will cover the products obtained directly by the patented process.

Patents cannot protect:

Health product patents are subject to the general regime. Some aspects, however, may be of particular relevance for the life sciences sector:

Where an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in a patent application in a manner that enables the invention to be reproduced by a person skilled in the art, the description will be considered inadequate for the purposes of patent law unless:

Portugal follows the controversies existing at the EU level on second medical use patents.

Under certain conditions, supplementary protection certificates (SPCs) for medicinal products can be granted (see Question 26).

Patent applications can be made by:

An application to the INPI should contain:

The application must be supported by the following elements:

Provisional patent application. To ensure the priority of a patent, it is possible to file a provisional application and postpone the submission of all the required elements of a full application for a maximum of 12 months.

Portugal recognises foreign priority for patent applications under the terms set out in the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention).

Patent application. Once an application has been submitted, a preliminary examination follows.

When all the formal requirements are satisfied, the intention to grant a patent is published in the national Industrial Property Bulletin within 18 months from the date of receipt of the application (exceptions can be made where an applicant requires an urgent publication).

In addition, the INPI carries out a prior art search to assess the patentability requirements (up to a maximum of ten months from the date of the application). The research report (which is not binding) is immediately sent to the applicant.

Patent application opposition. Proceedings can be initiated within two months from the date the application is published by INPI.

The final patent decision is notified by INPI to the applicant and published in the Industrial Property Bulletin.

Although there is no possibility of opposition after the patent has been granted, patents can be declared invalid on the following grounds:

Patent protection typically lasts for 20 years from the date of application and is not subject to extensions, although exceptions can apply.

Applications for SPCs for medicinal products can be submitted to the INPI, to extend protection by up to five years. The application must include:

In addition, a request for an extension of an SPC can be submitted in relation to medicinal products for paediatric use.

Supplementary protection certificates and extensions are provided by INPI in accordance with:

A patent holder has the right to prevent others from manufacturing, offering, storing, commercialising, or using a patented product or importing or possessing it for any of these purposes without their consent. A process patent holder has the right to prevent others from using the process, offering the process for use, and using, importing, storing, disposing of, or offering to dispose of a product directly obtained by the patented process.

A patent holder can oppose all acts constituting a violation of their patent, including:

Claim and remedies. A civil action can be brought against the infringer and claim relief including:

In addition, an unauthorised use of a patent is a criminal offence, subject to imprisonment for up to three years or a fine.

Defences against a patent infringement action involve, in general terms, invoking all arguments that call into question the rights that the claimant wishes to assert or that show that there is no infringement of those rights.

Research exemption. Conducting the necessary studies and trials with a view to authorising the marketing of a generic or similar biological medicinal product, including the granting of a marketing authorisation, does not infringe patent rights or SPCs for medicinal products (Bolar exemption).

IP exhaustion. The rights conferred by a patent do not allow its proprietor to prohibit acts relating to products protected by it after they have commercialised those products, or the products have been commercialised with their consent, within the European Economic Area (EEA), unless there are legitimate grounds for the patent owner to oppose the continued commercialisation of the products.

Portugal is party to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights. (TRIPS).

Portugal is a signatory to:

The following apply in Portugal:

Trade marks are governed by the Industrial Property Act.

Provided a trade mark adequately distinguishes the products and services of one company from those of others, it can include:

A trade mark can also consist of an advertising phrase for the products or services, provided it is distinct, regardless of protection conferred by copyright.

A medicinal name can be registered as a trade mark with the INPI.

A trade mark application must contain the following information:

The following cannot be registered as trade marks:

A trade mark application is submitted to the INPI. Detailed guidance on the applicable procedure and fees can be accessed on the INPI's website.

The standard fees for both an initial trade mark application and renewals are:

Once the application is filed, there is an initial examination in accordance with the rules governing the composition of trade marks. The application is published online in the national Industrial Property Bulletin.

Portugal recognises foreign priority for trade mark applications under the terms set out in the Paris Convention.

There follows an opposition period. Any opposition proceedings must be initiated within two months from the date the application is published by INPI.

The INPI carries out the substantive examination of the application, which consists of examining the trade mark to be registered and comparing it with other trademarks and distinctive trade signs. The INPI does not provide a search report.

If no grounds for refusal are found, the trade mark registration is granted and the approval decision is published.

The Competition Act (Law No. 19/2012, 8 May 2012, as amended (in Portuguese)) closely follows the EU competition law framework. Therefore, in addition to regulating the concentration of undertakings, the competition law regime enforces two essential prohibitions:

Therefore, agreements between companies, concerted practices between companies, and decisions by associations of companies which have as their object or effect the prevention, distortion, or appreciable restriction of competition in all or part of the national market, and the abuse by one or more companies of a dominant position on the national market or on a substantial part of it, are, as a rule, prohibited.

A breach of the antitrust rules can incur misdemeanour sanctions of up to 10% of a company’s annual turnover per infringement.

The Competition Authority is the public agency responsible for the enforcement of the national competition legal framework.

The competition authority has the power to issue administrative regulations, conduct studies, inspections and audits, and impose sanctions. In the context of the sanctioning procedure, the competition authority may require the provision of information from any natural or legal person, conduct interviews with any person, conduct searches, examinations, document collections, and seizures.

The Competition Authority has significant experience in merger cases in the pharmaceutical and health care sector, as reflected in decisions adopted in various procedures. Recent cases include:

The Competition Authority has investigated and adopted several antitrust enforcement decisions in the pharmaceutical sector. A recent case regarding unlawful conduct by several companies led to the imposition of fines (National Association of Pharmacies et al v Competition Authority), and was later judicially partially confirmed by the Competition Court and by the Lisbon Court of Appeal.

Another antitrust case handled by the Competition Authority concerned abuse of dominance by a pharmaceutical company in the context of tender proposals submitted to SNS hospitals (see Question 32). The infringing company was fined EUR900,000.

Settlements regarding the generic entry of pharmaceuticals in the market can be challenging from a competition law perspective, including those settlements that may lead to a delay of generic entry in return for a payment by the innovative company to the generic company.

Other examples of potentially problematic agreements relate to settlements that contain restrictions beyond the exclusionary zone of the patent. This means that these reach beyond a patent geographic scope, protection period, or exclusionary scope, as these agreements may not appear to directly relate to the IP rights granted by the relevant patents.

For example, the Competition Authority opened an antitrust inquiry (Case PRC 2014/4) after receiving information from the Secretary of State for Health regarding an agreement between pharmaceutical companies, under which the non-innovative company agreed to withdraw a generic medicine from the Portuguese market. The antitrust inquiry was concluded in 2016, following a Competition Authority decision without the adoption of a statement of objections deeming the companies' conduct lawful. The Competition Authority's findings in this investigation are the first in Portugal to combine competition law rules and IP law in the context of a patent settlement between originator and generic pharmaceutical undertakings. The decision provides ample guidance to economic agents regarding the requirements that must be fulfilled for these agreements to comply with competition law in Portugal.

The Competition Authority has adopted a decision finding a pharmaceutical company guilty of abusing its dominant position, in the context of proposals submitted in public tenders opened by several SNS hospitals (the Roche case Proc. PRC/2008/10). The Competition Authority's investigation was based on a complaint lodged by a biopharmaceutical company that was a direct competitor in public tenders involving the supply of several medicines. Due to its market share in several relevant medicine markets, the defendant company was considered to have a dominant position in relation to part of the medicines included in the proposals submitted to the hospitals. On the basis of the submitted documentary evidence (for example, tender announcements, tender bids and award decisions), the Competition Authority concluded that the defendant abused its dominant position in relation to several relevant medicine markets by, among other things, offering mixed-bundle and loyalty rebates in its medicine tender proposals, thereby infringing the relevant provision of the Competition Act. Although it took into account the mitigating circumstances of the defendant's co-operation throughout the inquiry, the Competition Authority still ruled against the company, imposing a misdemeanour fine of EUR900,000.

Issues have surfaced relating to parallel imports and competition law, including in the context of marketing authorisation holders aiming to secure the adequate and continuous supply of the national market, although these have not led to formal decisions by the Competition Authority.

Agreements on the licensing of technology and patents in the pharmaceutical sector can be caught by Article 101 of the Treaty on the Functioning of the European Union (TFEU) and by the equivalent national provisions, Articles 9 and 10 of the Competition Act.

Relevant competition rules are found in the Technology Transfer Block Exemption Regulation (316/2014), which, under the Competition Act, must be closely followed by the Competition Authority.

Generally, competing companies under a licensing of technology or a patent agreement, or any other agreement, cannot directly or indirectly, in isolation or in combination with other factors under their control, have as their object any of the following:

There are no restrictions on licensing or transferring patents to foreign parties, or on intellectual property transfers for inventions that are funded (or partially funded) by public investment.

There are no requirements for either a patent or trade market licence agreement or payment of royalties to be approved or accepted by a government or regulatory body. However, licences must be drawn up in writing and if the grant of sublicences is not authorised by the licence, these can only be granted with the written authorisation of the right holder (Industrial Property Code).

Licence agreements must be registered with the INPI to be made enforceable against third parties.

INFARMED is the key regulator of medicinal product liability and its powers in this context are extensive. Under the Medicines Act, there is also a National Pharmacovigilance System of Medicines (a platform for the centralisation of information on adverse reactions, for which INFARMED is responsible).

Marketing authorisation holders, wholesalers, distributors, and pharmacies must make their premises, installations, products, and documents (including sensitive information and proprietary data) accessible at all times to INFARMED. In addition, market authorisation holders/wholesalers must have an emergency plan, which ensures effective implementation of any recall from the market ordered by INFARMED for the medicinal product concerned.

Non-compliance with the relevant provisions of the Medicines Act or with INFARMED's decisions is subject to a misdemeanour fine of between EUR2,000 and up to 15% of the annual turnover of the infringer or EUR180,000 (whichever is the lower) per infringement imposed by INFARMED, without prejudice to potential criminal, tort, and disciplinary liability.

INFARMED can also revoke, suspend, or modify a marketing authorisation because, among other things, a medicine is unsafe. As a rule, when the medicine is marketed in other EU member states, any safety decision is co-ordinated with the EMA and the competent national authorities of the other EU jurisdictions where the product is marketed.

Medicinal product liability can arise under criminal law, contract, and tort law.

Portugal has a specific legal regime for product liability set out in Product Liability Act (Decree-Law No. 383/89, 6 of November 1989, as amended (in Portuguese)) based on the Product Liability Directive (85/374/EEC) as amended by the Product Safety Directive (1999/34/EC).

The injured person must prove:

( Article 1 of Product Liability Act.)

The Civil Code (Decree-Law no. 47344 of 25 November 1966, as amended (in Portuguese)also recognises tort liability based on:

Under the Civil Code, liability depends on the fulfilment of five cumulative requirements:

A claim for damages can also be brought under contractual liability, where there is a contract between the wrongdoer and the natural or legal person suffering the damage.

The producer is liable for any damage, independently of fault, caused by a defect in their product. The producer is defined as one of the following:

(Article 2, Product Liability Act.)

In addition, without prejudice to the liability of the producer, any person who imports into the EU a product for sale or any form of distribution in the course of their business is also considered to be a producer and is responsible as a producer. If the producer cannot be identified, each supplier of the product is treated as its producer unless they inform the injured person, within a reasonable time, of the identity of the producer or of the person who supplied them with the product. (Article 2, Product Liability Act.)

Standard defences in a product liability claim include that:

The issue of limitation of liability is a very controversial one, especially when it comes to limitation of liability for damages that may result from a medicinal product. A case-by-case analysis is necessary to answer whether a specific limitation of liability is valid.

The limitation periods for bringing a product liability claim are:

(Articles 11 and 12, Product Liability Act.)

Law No. 83/95, 31 August 1995, as amended (in Portuguese) establishes the legal framework applicable to a representative action. The aim of this type of action is to represent collective or diffuse interests either for prevention (injunction) or for redress (claims for damages). A representative action for a product liability claim in the Portuguese courts can be brought by:

(Article 2(1), Law 83/95.)

Companies cannot use the representative action procedure.

The Portuguese procedure is an opt-out system. The claimant automatically represents all the holders of similar rights or interests at stake who do not opt out following, among others, a public notice of submission of the representative action before the court. The claimant can seek redress for damages suffered, but compensation cannot be individually identified and will be determined globally. Representative actions in the context of product liability claims are rare in Portugal.

The claimant (or their estate) can claim damages for:

Punitive damages are not available in Portugal for product liability claims.