Life Sciences 2022

Last Updated April 05, 2022

Portugal

Law and Practice

Authors



PLMJ is a law firm based in Portugal that combines a full service with bespoke legal craftsmanship. For more than 50 years, the firm has supported clients in all areas of the law, often with multidisciplinary teams, and always acting as a business partner in the most strategic decision-making processes. PLMJ has specialist lawyers that know the sectors and markets they work in well, and keep in close contact with the regulators for each sector. The firm created PLMJ Colab, a collaborative network of law firms spread across Portugal and other countries with which it has cultural and strategic ties. PLMJ Colab makes the best use of resources and provides a concerted response to clients' international challenges. International co-operation is ensured through firms specialising in the legal systems and local cultures of Angola, Cabo Verde, China/Macau, Guinea-Bissau, Mozambique, São Tomé and Príncipe, and Timor-Leste.

The rules on medicines for human use come from Decree-Law 176/2006 of 30 August 2006 ("Decree-Law 176/2006"), and the rules on medical devices from Decree-Law 145/2009 of 17 June 2009 ("Decree-Law 145/2009") and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (MDR). There are also several sets of regulations implementing the decree-laws in different matters.

The regulatory body which applies and enforces pharmaceutical and medical device regulation is the National Authority of Medicines and Health Products, IP (INFARMED).

INFARMED is part of the State's indirect administration and is endowed with administrative and financial autonomy. It is responsible for carrying out the responsibilities of the Ministry of Health under the supervision and guidance of the Minister of Health.

As a rule, decisions regarding expenditure on medicines and medical devices are taken by the Minister of Health, who may delegate these decisions to INFARMED.

INFARMED's decisions regarding medicines and medical devices may be challenged through administrative and/or judicial channels, within a given period.

Individuals and entities who are affected by these decisions can react against them, namely on the grounds of breach of the law. These means of reaction are common to decisions that affect other products (eg, food supplements), although there may be specific details.

There are categories of medicines and medical devices subject to specific regulation. This is the case of medicines containing psychotropic and narcotic substances, which are regulated, namely, by Decree-Law 15/93 of 22 January 2022, Decree-Regulation 61/94 of 12 October 1994 and Law 33/2018 of 18 July 2018. It is also the case of medical devices for in vitro diagnosis, which are regulated by Decree-Law 189/2000 of 12 August 2000.

Clinical trials of medicines and clinical studies of medical devices are regulated by different pieces of legislation.

Medicines

Clinical trials on medicines are regulated by Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 ("Clinical Trials Regulation") and Law 21/2014 of 16 April 2014 ("Clinical Trials Law").

The entry into force of the Clinical Trials Regulation on 31 January 2022 involved the entry into force of the Clinical Trials Information System (CTIS), through which all clinical trial submission, assessment and supervision processes in the EU are to be submitted. The Clinical Trials Regulation provides for a three-year transition period, with the following timeline:

  • from 31 January 2022 to 31 January 2023, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive or through the CTIS;
  • from 31 January 2023, new applications for clinical trials in the EU and the European Economic Area are submitted under the CTIS; and
  • by 31 January 2025, all ongoing trials will have to be transferred to the CTIS under the Clinical Trials Regulation.

Medical Devices

The rules regarding clinical studies of medical devices are found in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and in Decree-Law 145/2009, which establishes the rules regarding research, manufacturing, marketing, putting into use, monitoring and advertising of medical devices and their accessories. With the entry into force of the MDR, the rules of Decree-Law 145/2009 that contradict the MDR are no longer applicable, and only the rules that do not contradict the MDR remain in force. The Portuguese legislation implementing the MDR is undergoing the legislative process and awaiting publication.

In Vitro Medical Devices

The legal rules applicable to in vitro medical devices are established in Decree-Law 186/2000, of 12 August and Decree-Law 145/2009.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVMDR) will enter into force on 26 May 2022 and it is expected that the entry into force of the IVMDR will mean that any national rules contradicting it will no longer apply.

Medicines

Obtaining an authorisation to conduct a clinical trial of a medicine may, in the transition period until 31 January 2023, be done under the rules established in the Clinical Trials Law or through the CTIS, pursuant to the Clinical Trials Regulation.

Should the sponsor opt for the Clinical Trials Law arrangements, the application for authorisation to conduct clinical trials must be submitted to INFARMED through the National Clinical Trials Register, together with the relevant documentation.

INFARMED will decide on the application for authorisation within 30 days and may ask the applicant for additional information to the application once only.

The sponsor may, within the period granted, change the content of the application for authorisation, only once, and the period will be suspended until the change is made. If the sponsor does not change the application as requested, the clinical trial may not be conducted.

INFARMED may decide on the need to obtain express authorisation to conduct trials involving the following medicines:

  • without marketing authorisation (MA) and that are listed in Annex A to Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004; and
  • which have special characteristics, namely, those whose active substance or substances are biological products of human or animal origin, contain biological components of human or animal origin, or whose production requires such components.

Clinical trials involving medicines:

  • for gene therapy;
  • for somatic cell therapy;
  • containing genetically modified organisms; and
  • for xenogeneic cell therapy will require express authorisation from INFARMED. 

If the application for authorisation is submitted under the Clinical Trials Regulation, it should be submitted through the CTIS and the sponsor of that application should propose a reporting member state, which will be responsible for the analysis of the application. 

Medical Devices

Applications to conduct clinical investigations as defined in the MDR must be submitted by the sponsor to the member state or member states in which the clinical investigation is to be conducted. The application must be submitted through the electronic system referred to in the MDR, accompanied by the documents referred to in Chapter II of Annex XV of the MDR.

Clinical trials of medicines and clinical studies of medical devices are available on the National Clinical Trials Register website at http://www.rnec.pt. The results of clinical trials and clinical studies of medical devices are not available in public access databases.

The methods of recruitment for clinical trials of medicines and clinical studies of medical devices must follow the legally prescribed rules. In addition to physical advertising methods, digital means can be used for this purpose. These means may also be used for monitoring purposes, provided that they do not jeopardise the purpose and safety of the trial.

Data from clinical trials of medicines and clinical studies of medical devices may qualify as personal data in the sense of sensitive data. However, if the data are fully anonymised (and not merely pseudonymised), they are no longer personal data and, therefore, do not fall within the category of sensitive data either. Anonymisation implies that the identity of the data subject is unobtainable, in which case the data become anonymous.

If the resulting data is still personal data, it might be transferred to third-parties or affiliates, provided such transfer complies with the requirements set out in the General Data Protection Regulation (GDPR), notably when it comes to consent and information obligations, security of the processing issues, joint-controllership or sub-processing agreements, and international data transfers. If the resulting data is anonymised data, then those GDPR requirements do not apply.

The requirements under the GDPR regarding the processing of health data apply, namely, with regard to the grounds for lawfulness of processing, transparency and security measures.

The product is classified through the definition of medicine (function and/or presentation) and the definition of medical device provided in the applicable legal provisions. In the case of borderline products, the purpose intended by the manufacturer of the product in question and the mechanism through which the main desired effect is achieved are taken into consideration.

Medicines developed by means of one of the following biotechnological processes must be subjected to the centralised community procedure:

  • recombinant DNA technology;
  • controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; and
  • hybridoma and monoclonal antibody methods.

In the case of medicines, the MA is valid for five years and, after the first renewal, it is valid indefinitely or, if considered necessary, for a second five-year period. The renewal of the MA is subject to a specific renewal procedure.

An MA may be revoked, suspended or amended whenever there is non-compliance with the applicable legal and regulatory provisions, or with the conditions of the MA in question. This includes when it is concluded that the risk-benefit balance is unfavourable, the medicine is harmful, or the manufacturing process does not comply with the applicable good practices.

In the case of medical devices, no authorisation is required for placing such devices on the market. The manufacturer must submit the medical device to a conformity assessment and notify the competent authority that the medical device has been made available on the market. Under certain conditions, namely when the use of medical devices could compromise the health and safety of patients or other persons or for public health reasons, INFARMED may withdraw from the market or suspend, restrict or subject to certain conditions the placing on the market and putting into service of a device or group of medical devices.

The marketing of a medicine may follow one of these procedures:

  • a national procedure, if the medicine is intended to be approved only for placing on the Portuguese market;
  • a mutual recognition procedure, in which an authorisation obtained in a member state is used to apply for authorisation in a new member state;
  • a decentralised procedure, when the application is submitted in several member states simultaneously and when the medicine does not have an MA in any member state; and
  • a centralised procedure, managed by the European Medicines Agency (EMA), leading to an MA valid in all member states.

Any change in the terms of an MA, including the summary of product characteristics and any conditions, obligations or restrictions affecting the MA, or changes to the labelling or package leaflet in connection with changes to the summary of product characteristics, must be subject to an application for a variation of the MA.

An MA may be transferred to a new holder through the submission of a transfer application submitted by the MA holder.

The placement of a medical device on the market does not require authorisation (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceutical or Medical Devices).

Medicines without an MA or without an MA valid in Portugal may be made available to patients through the exceptional use authorisation. Under exceptional use authorisations, those medicines can be accessed by patients through an early access programme, which have a specific regulation issued by INFARMED.

Regarding medical devices, INFARMED may authorise the placing on the market or putting into service of a medical device for which no conformity assessment procedures have been carried out but which use is in the interest of public health or patient safety or health.

Compassionate use also takes place in the context of clinical trials.

The MA for a medicine may be granted subject to the subsequent conduct of additional studies or compliance with special rules, namely regarding safety and the reporting of all incidents associated with the use of the medicine and the measures to be taken, the conduct of a post-authorisation safety or efficacy study, or the fulfilment of other obligations established by INFARMED.

After the granting of an MA, INFARMED may require its holder to conduct a post-authorisation safety study if there are doubts about the risks of the authorised medicine or if knowledge about the disease or clinical methodology indicates that previous efficacy evaluations may need to be significantly revised.

The holder of an MA is obliged to comply with the obligations provided for by law, namely, to comply with pharmacovigilance obligations and to made available to INFARMED these or other data proving that the benefit-risk relationship of the medicine remains favourable.

Manufacturers of medical devices other than investigational devices must report to INFARMED any field safety corrective action and any serious incident or any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side effects that could have a significant impact on the benefit-risk analysis, and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons.

INFARMED publishes information on the status of an MA application and its assessment report on its website. It suppresses any commercially confidential information and allows access to the summary of product characteristics and the package leaflet, as well as information on the medical devices placed on the market.

Decree-Law 26/2018 of 24 April 2018 has incorporated the European legislation on falsified medicines into Portuguese law. This legislation establishes the mandatory placement of safety devices on the packaging of certain medicines, which must be checked by all participants in the chain, to allow the detection of falsified or adulterated medicines in the circuit and the individual identification of packaging.

Under the regulatory framework, INFARMED must draw an annual surveillance activity plan and perform appropriate checks on the conformity characteristics and performance of medical devices including, where appropriate, a review of documentation and physical or laboratory checks based on adequate samples.

INFARMED established a protocol with the Tax and Customs Authority to inspect and intercept counterfeit medicines. The Legal Framework for Tax Infractions and Customs Crimes also provides for the existence of customs offences and crimes associated with the counterfeiting of goods, which may include counterfeit medicines and medical devices.

The manufacture of medicines, experimental medicines and the manufacture of medical devices requires authorisation from INFARMED.

The manufacture of medicines requires the existence of facilities licensed for the purpose and compliance with good manufacturing practices. The facilities are subject to periodic inspections by INFARMED, which certifies their compliance and issues a certificate of good manufacturing practices, which is valid for three years.

As for medical devices, facilities must obtain an industrial activity licence in accordance with the applicable legislation and have an industrial activity code associated with the categories of medical devices produced in conjunction with the respective manufacturing activities performed.

The authorisation for wholesale of medicines is issued by INFARMED and includes the activities of supply, holding, storage or delivery of medicines for processing, resale or use in medical services, health care facilities and pharmacies, being excluded the supply to the public. It specifies the facilities from which distribution is carried out and is subject to the validity of the certificate of good distribution practices, which must be renewed every five years.

The wholesale of medical devices is subject to prior notification to INFARMED and includes the activities of supply, holding, storage or supply of medical devices for resale or use in medical services, health care facilities, pharmacies and other points of sale to the public, being excluded the supply to the public. The application must be submitted at least 60 days before the start of the distribution activities and must include the full address of the distribution facilities and does not have an expiration date.

Medicines are classified, as regards dispensing to the public, into prescription-only medicines (MSRMs) and non-prescription medicines (MNSRMs). The former can also be classified as renewable, special or for restricted use in specialised monitored conditions and the latter as MNSRMs for dispensing only in pharmacies.

The import and export of medicines is regulated by Decree-Law 176/2006 of 30 August 2006 and by related legislation on good practice in transportation and distribution. As regards medical devices, the MDR and Decree-Law 145/2009 are applicable.

INFARMED is the entity responsible for monitoring compliance with these regulations. 

Any natural or legal person duly authorised and licensed for that purpose by INFARMED can be an importer of medicines and medical devices.

The import and export of medicines and medical devices requires that the economic operator is licensed by INFARMED for that purpose. For personal use, medicines can be transported only for the necessary period, provided that they are accompanied by a medical prescription, when necessary. In the case of emergency situations or donations, INFARMED will assess each case individually.

The regulations to be considered upon importation of any products into the Portuguese territory, which is part of the customs territory of the European Union, are:

  • Regulation (EU) 952/2013 of the European Parliament and of the Council of 9 October 2013, which approves the Union Customs Code;
  • Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015; and
  • Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015.

Portugal is part of the EU and the single European market and it applies the principle of free movement of goods and services, and also has harmonised regulatory rules for medicines and medical devices.

Price Control for Medicines

Except for non-reimbursed MNSRMs, which have free pricing arrangements, all other medicines have their prices regulated.

Medicines with regulated prices are subject to maximum price rules or notified price rules. They cannot be sold unless the MA holder obtains a retail price (RP).

The RP of the medicine is composed of:

  • the ex-factory price (EFP), which is the maximum price at the stage of production or import and has fixed rules for its determination;
  • the wholesalers' and retailers' selling margins, as fixed by ministerial order;
  • the tax on the sale of medicines (currently set at 0.4%); and
  • value added tax (VAT).

The MSRMs intended to be dispensed and used in National Health Service (NHS) establishments are also subject to maximum price rules and their final price is composed of the EFP, the sale tax, and the VAT.

The prices of medicines subject to the maximum price rules are reviewed annually. The pricing rules for medicines are set out in Decree-Law 97/2015 of 1 June 2015 and regulated by several Ministerial Orders (in particular Ministerial Order 195-C/2015 of 30 June 2015 and Ministerial Order 154/2016 of 27 May 2016).

Requests for price authorisation and price revision communications follow their own procedures and are submitted by the MA holder to INFARMED.

Price Control for Medical Devices

As a rule, medical devices financed by the State have fixed maximum prices. Medical devices not financed by the State have free pricing.

The pricing rules for medical devices are set out in Decree-Law 97/2015 of 1 June 2015, and there are Ministerial Orders that define the maximum prices applicable to certain devices or groups of medical devices, which usually include the marketing margins and VAT. In these cases, the RP proposed is indicated by the manufacturer at the time of the request for reimbursement to INFARMED, which follows its own procedure.

Price Levels of Medicines

The price of medicines is generally set and reviewed on the basis of the prices in the reference countries, defined annually among EU countries with comparable GDP per capita or lowest price level.

Price Levels of Medical Devices

The price of medical devices does not depend on the prices applied in other countries.

Public financing of medicines and medical devices depends on an application to INFARMED by the MA holder or the manufacturer, respectively. This public financing may be full or partial and varies according to various factors, including pathologies or special groups of patients, therapeutic indications, prevalence of certain diseases in the population, etc, see 7.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices.

Cost-Benefit Analyses for Medicines

State funding of medicines is, as a rule, cumulatively subject to prior technical-scientific demonstration of therapeutic innovation or equivalence for the therapeutic indications claimed, as well as demonstration of the economic advantage of the medicine. These factors are not decisive in fixing the price of medicines, because these prices tend to be fixed taking into account the prices in the reference countries, see 7.1 Price Control for Pharmaceuticals and Medical Devices and 7.2 Price Levels of Pharmaceutical or Medical Devices.

Cost-Benefit Analyses for Medical Devices

A cost-benefit analysis is also carried out in the financing of medical devices by the State, namely considering the therapeutic innovation demonstrated for the clinical purposes claimed and the demonstration of an economic advantage, see 7.1 Price Control for Pharmaceuticals and Medical Devices.

In order to ensure the sustainability of the NHS, the prescription of reimbursed medicines is made using the international non-proprietary name and may only include the commercial name of the medicines in the exceptional cases listed in the law. Pharmacies are obliged to inform the patient about the medicine that, in compliance with the prescription, has the lowest price. These rules apply to reimbursed medical devices, with the necessary adaptations. 

As software, medical apps are considered active medical devices under the MDR, being lifestyle and well-being apps expressly excluded from the scope of the MDR. The classification criteria are provided by the MDR and supporting documents published for this purpose by the European Commission. 

The rules on telemedicine are laid down in the Code of Ethics of the Portuguese Medical Association, which establishes standards for the safety and quality of the means used.

Advertising for medicines and medical devices is highly regulated, and there are specific regulations for each of these product categories which are also applicable to online portals, company webpages and social networks.

Electronic prescribing is the rule and has been in place for several years. Non-electronic prescriptions are exceptions and are only allowed in specific cases.

Regarding medicines, under certain circumstances, pharmacies and MNSRM outlets can perform home delivery of medicines, and such medicines can be ordered over the Internet. Medicines cannot be delivered by post or courier.

It is possible to market medical devices online and deliver by post or courier. Admissibility must be assessed on a case-by-case basis and, in any case, the quality of the medical device must be guaranteed. 

Health-related records are regulated as health data under the GDPR. Health-related information is considered sensitive data under the GDPR. Moreover, Law 58/2019 of 8 August 2019, which ensures the implementation of the GDPR, contains specific obligations regarding professional secrecy. These obligations apply to all member of corporate bodies, employees and service providers of the controller, and to students and researchers in the field of health who have access to these data. The data subject must be notified of any access made to their personal data and the controller must ensure that a traceability and notification mechanism is in place.

There are no special requirements for cloud platforms. Portugal does not restrict the processing of health data to its territory, so the general rules provided in Chapter V of the GDPR on international data transfers apply. It is permitted to store sensitive patient data on cloud platforms. However, regarding information security, in addition to the general requirements of the GDPR, most public bodies, including public hospitals, are bound to comply with Council of Ministers Resolution 41/2018. This defines technical guidelines for the Public Administration on security architecture of networks and information systems regarding personal data.

The Portuguese Industrial Property Code (IPC) contains the most relevant provisions for patents, including for patent prosecution and enforcement.

Special inhibitory actions relating to pharmaceutical patents and generic medicines are available under Law 62/2011 of 12 December 2011 (“Law 62/2011”).

The most common issues encountered by pharmaceutical companies in Portugal relate to patent disputes between originator and generic companies under Law 62/2011. Other issues that usually arise relate to the validity of patents and supplementary protection certificates (SPC).

There are no specific patentability requirements for medicines or medical devices per se. However, according to the IPC, processes for cloning human beings, processes for modifying the germinal genetic identity of the human being and uses of human embryos for industrial or commercial purposes are not patentable.

Methods of surgical or therapeutic treatment are also not patentable, but the products, substances or compositions used in any of these methods may be patented.

Second and subsequent medical uses of a known substance or composition are regarded as patentable in Portugal, provided that any such use meets the general patentability requirements.

According to the Guidelines of the Portuguese Institute of Industrial Property, the term “use” may include new dosage regimes and new patient groups.

There is no clear guidance from the Portuguese courts as to what specific activities constitute infringement of second and subsequent patents of medicines. However, in a 2015 judgment, the Lisbon Second Instance Court decided that the patent-holder of a second medical use patent can only react against the applicant of an MA for the generic medicine if the active pharmaceutical ingredient is prepared and adopted for the specific therapeutic use that is patented. In the first instance decision of this case, the ad hoc arbitral tribunal considered that if the generic medicine does not have the patented use as a therapeutic indication according to the granted MA, one cannot conclude that there has been an infringement of the second use patent. 

The patent-holder may obtain a patent term extension for medicines by applying for a supplementary protection certificate (SPC).

The application for a SPC is regulated in the IPC and is governed by Regulation (EC) 469/2009 of the European Parliament and of the Council of 6 May 2009 (“SPC Regulation”). The SPC application must be filed with the Portuguese Industrial Property Office (INPI) in Portuguese, with a copy of the first MA of the product in Portugal.

If granted, the SPC can extend the protection conferred by the basic patent for the time that has passed between the filing of the patent application and the date of grant of the MA, minus five years.

The validity of the SPC cannot exceed five years from the expiry of the basic patent, except when it concerns medicines for paediatric use, where a further six-month extension is available. 

Patent term extensions via an SPC may be challenged by any interested party before the INPI if the date of the first MA indicated by the patent-holder in the SPC application is incorrect. The INPI can also amend the validity period of an SPC of its own motion when it verifies the existence of an error.

An action for the revocation of an SPC can be brought by any interested party before the Portuguese Intellectual Property Court, under the IPC.

Similarly to other patents, medicine or medical device patents give the patent-holder the right to prevent any third party, from:

  • manufacturing, offering, stocking, placing on the market or using a product which is the subject matter of the patent, or importing or possessing it, for any of the purposes previously mentioned;
  • using the process which is the subject matter of the patent or, if the third-party knows or should have known that the use of the process is prohibited without the consent of patent-holder, offering to use it; and
  • offering, stocking, placing on the market and using, or importing or possessing for those purposes, products obtained directly by the process which is the subject matter of the patent.

Applying for an MA does not qualify as a patent infringement action in Portugal. However, the publication of an MA for a generic medicine by INFARMED enables the patent-holder to file a special inhibitory action under Law 62/2011 for invoking incompatible patent right(s). The patent-holder can also request the IP Court (or an arbitral tribunal, if arbitration is agreed between the parties), in such action, to determine precautionary measures to prevent infringement of the patent in question.

The threat of infringement is actionable to inhibit any imminent infringement.

Specific defences to patent infringement in relation to medicines and medical devices in Portugal include an experimental use exemption and, in particular, the Bolar exemption.

Compulsory licences on patents are provided for, in general terms, in the IPC, but there are no relevant precedents in Portugal with regard to the granting of compulsory licences. In any case, compulsory licences may be granted in Portugal in the following situations:

  • lack or insufficient exploitation of the invention;
  • dependency between patents;
  • public interest;
  • under EU and Portuguese Competition law; and
  • under Regulation (EC) 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of medicines for export to countries with public health problems.

Patent infringement proceedings may be brought by the patent-holder as well as by the licensee. The licensee’s right to bring an action depends on the specific terms of the corresponding licence agreement and on the record of the licence at the INPI.

Although patent infringement is a crime under Portuguese law, the typical procedure for a patent infringement actions is a civil lawsuit at the IP Court. Special inhibitory actions relating to pharmaceutical patents and generic medicines are available under Law 62/2011 and must be also filed at the IP Court or, upon agreement of the parties, before an institutional or ad hoc arbitral tribunal.

Civil remedies include preliminary and permanent injunctions, granting the patent-holder the right to prevent any imminent infringement or to prohibit the continuation of the infringement. There is also the possibility of requesting the IP court to order the infringer to pay a periodic penalty for breach of the judgment, and to order the destruction, recall or definitive removal from the channels of commerce of the infringing goods. Damages claims for infringement are also possible.

Invalidity is available as a defence in civil infringement proceedings on the merits, through the filing of a counterclaim for revocation of the patent or SPC.

In theory, under the Civil Procedure Code, pre-launch declaratory actions are possible for generic market entrants, although we are not aware of any relevant precedents in Portugal in this regard. Nullity actions for the invalidation of patents or SPCs in advance of attempted market entry are also possible.

Law 62/2011 (explained above) created a special action applicable to patent litigation involving generic medicines, whereby patent-holders can pursue an early assessment of prospective patent infringement, after publication of the MA applications for generic medicines. This law led to a large number of court cases and also to a large number of settlement agreements between patent-holders and generics.

Although the procedure provided for in Law 62/2011 is triggered by the publication of the MA, this procedure does not stay the grant of the MAs or their effect once granted, which means that no patent linkage effect exists.

Counterfeiting consists in the complete reproduction of a sign protected as a trade mark. The IPC provides that trademark counterfeiting is a criminal offence, punishable with imprisonment for up to three years or a fine of up to 360 days. Civil liability also arises from trade mark counterfeiting.

Custom procedures against counterfeit medicines and medical devices are available under Regulation (EU) 608/2013 of the European Parliament and of the Council of 12 June 2013.

Besides the general requirements and impediments provided for in the IPC with respect to trade mark composition (that apply to all marks), Decree-Law 176/2006 further provides that the name of a medicine may comprise a trade mark, as long as that trade mark is not misleading with regard to the therapeutic properties and nature of the product.

Furthermore, the EU Regulations on medical devices also prohibit the use of misleading trade marks.

Under trade mark law, non-counterfeit genuine medicine or medical device products may suffer import restrictions if there is a prior registered trade mark in Portugal that prevents the use of the mark by the importer (eg, on the basis of likelihood of confusion).

IP protection for the trade dress or design of medicines and medical devices, or their packaging is potentially available under design rights, copyright and trade mark rights, provided they meet the legal requirements for that protection.

According to an a contrario interpretation of Decree-Law 176/2006, data exclusivity for medicines (chemical drugs and biologicals) will last for at least eight years from the date of granting of the MA for the reference medicine.

Under the same Decree-Law, marketing exclusivity of the reference medicine lasts ten years from its first MA approval, or eleven years from its first MA approval if the originator obtained, within eight years of that date, a new therapeutic indication that brings significant clinical benefit.

During COVID-19 pandemic, INFARMED has issued guidelines to simplify the import and export of medicines, namely regarding the import and export of medicines with controlled substances.

INFARMED also issued transitional guidelines to make the import, manufacture and distribution of medical devices faster and more efficient during the pandemic. It has also relaxed a number of rules that made it very time consuming to obtain the necessary devices.

Within the constraints imposed by the pandemic, INFARMED issued guidelines to mitigate the impact of the pandemic on clinical trials in progress or about to start. These measures do not specifically target clinical trials of medicines to treat COVID-19. INFARMED stressed the possibility of remote visits through technological means, ensuring the collection and recording of the information foreseen for the visit.

The EMA also implemented exceptional measures regarding the approval and documentation of medicines to treat COVID-19.

The EMA has created a specific, more expedited procedure for the approval of medicines, which is characterised by significantly shorter timeframes for the review and approval process.

Within the context of the COVID-19 pandemic, INFARMED has established special and temporary abbreviated procedures on the certification of medical devices essential to answer the needs caused by the pandemic, namely for the certification of medical devices such as surgical masks and ventilators for medical purposes.

In the context of the outbreak of the pandemic, INFARMED and other authorities issued guidance on easing import requirements for medical devices needed to contain the spread of the virus.

Telemedicine was already allowed in Portugal before the pandemic. These means were used more frequently during the pandemic period considering the saturation of the NHS hospitals and health facilities.

There is no intention to issue compulsory licences for COVID-19-related treatments or vaccines.

There are no liability exemptions introduced in existing or new provisions regarding COVID-19 vaccines or treatments.

During the pandemic period, industries were turned over to the production of medical devices. Several textile industries temporarily converted their production to produce medical devices (mainly surgical masks).

Measures to make public procurement more flexible were adopted to ensure the immediate availability of goods and services needed to urgently respond to the pandemic. In addition, an exceptional system of public procurement, expenditure authorisation and administrative authorisation was created. In this system, the creation of exceptional arrangements for simplified direct adjustment stands out, particularly for the acquisition of medicines and medical devices.

PLMJ

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+351 213 197 300

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Trends and Developments


Authors



Sérvulo & Associados – Sociedade de Advogados, SP, RL is a Portuguese full-service law firm which occupies a leading position in the Portuguese legal market. Recognised for the quality of its legal services in all relevant areas of law and strategic sectors, SÉRVULO has a highly competent multidisciplinary team of more than 100 lawyers, motivated by a single purpose: to transform academic research and accumulated knowledge in the design of sound legal solutions, thus creating added value for its clients. SÉRVULO is trusted by a vast number of the main private and public entities, both domestic and international, in the Portuguese-speaking legal markets and in all the most significant economic sectors. It houses a roster of lawyers that are fully capable of facing all of the challenges that may arise at any time and in any field of the law. SÉRVULO’s practice areas are recognised by the main legal directories.

COVID-19: the Other Side of the Coin

In the past two years, COVID-19 has been a recurring theme and it imposes itself on every analysis due to the transversality of its impact. The life sciences sector is not an exception, being one of the sectors that suffered an extraordinary and positive impact with the pandemic crise.

Today, and more than ever, strengthening the Portuguese National Health Service is essential, but the strategic focus on the health sector goes far beyond health care, recognising this sector as an important hub for the country's development.

Portugal has implemented the “Health Cluster Portugal” platform, which includes R&D pharmaceutical companies, hospitals, universities and government bodies. This platform is Oporto and aims to turn Portugal into a competitive player in the research, invention, developing, manufacturing and commercialisation of products and services of high added value. It currently holds approximately 170 members, embracing the entire field of life sciences in the country. Further, healthtech start-ups have been placed in the Portuguese market in both sections: digital health (ie, EyeConnect and Phast) and medical devices (ie, Pineal Technologies 3D and Cepha).

The quantified self is also a trend that calls the attention on data privacy issues. Challenges in the field of information security and data protection have emerged.

The pandemic has accelerated virtualisation in both consumer and clinical trial contexts giving rise to the growth of decentralised clinical trials. These changes give rise to a host of complex legal and regulatory aspects impacting both life sciences companies and their financial backers.

In Portugal, the National Authority of Medicines and Health IP's (INFARMED) Strategic Plan 2020–22 gives emphasis to the following key ideas and common concerns:

  • availability and access to human and veterinary medicines;
  • adoption of emerging technology (artificial intelligence and data analytics);
  • support for innovation; and
  • challenges associated with supply chains.

Infarmed’s Relevant Data

According to INFARMED’s data, in Portugal, the market for medicines and health products (medicines for human use, medical devices and cosmetics) is estimated to exceed EUR7.3 billion, representing approximately 3.5% of the national gross domestic product (GDP).

The number of clinical trials authorised in Portugal registered a slight drop of 7% compared to 2020, according to the most recent information. However, most of the registered data does not show major oscillations.

Phase III clinical trials continue to have the highest expression in Portugal, representing 57% of the total number of clinical trials submitted in 2021. However, in comparison with data from 2010, there is a significant increase in the number of investigator-initiated trials (phase I), which grew from 2% in 2010 to 22% in 2021.

With regard to the authorship of the proposed and authorised trials, the pharmaceutical industry remains the major promoter of clinical research in Portugal. In 2021, 95% of trials submitted were initiated by the industry.

Regarding the therapeutic areas, there is no significant change between 2010–21, with clinical trials with antineoplastic, immunomodulatory, gastrointestinal, metabolic, as well as central nervous system and cardiovascular system drugs remaining predominant.

Life Sciences and Technology

The culture in health care is characterised by a wide-scale adoption of new digital and cognitive health technologies.

Development of robotics process automation in areas like drug discovery or data analysis is the new rule. Artificial intelligence has revolutionised health care through mining medical records, designing treatment plans, speeding up medical imaging and drug creation.

The legal and regulatory setting in Portugal is not yet prepared for the new technologies. However, some attempts have been made to accompany this evolution.

The Council of Ministers Resolution No 131/2021 approved the Digital Transformation Strategy for Public Administration 2021–26 and the respective Transversal Action Plan for the legislature.

This strategy aims to make public administration more responsive to the expectations of citizens and businesses, providing simpler, more integrated, and inclusive services, operating more efficiently, intelligently, and transparently, by exploiting the potential transformation of digital technologies and the intelligent use of data.

This project is based on six strategic lines of action:

  • digital public services;
  • data valorisation;
  • reference architectures;
  • information and communication technology (ICT) skills;
  • ICT infrastructures and services; and
  • security and trust.

Also significant is the activity of Portugal within the European network of health technologies (EUnetHTA) – a consortium represented by 13 European agencies, where INFARMED is included, which aims to improve the availability of innovative health technologies for citizens and strengthen the quality of health technology assessment at a European level, also embodying INFARMED's mission.

EUnetHTA 21 will continue the work conducted under the EUnetHTA joint cooperation (which ended in May 2021). The concluded agreement is intended to serve the new legal framework for co-operation in health technology assessment. In addition, joint clinical assessments will be carried out under the contract and joint scientific advice will be provided. This advice will run in parallel with the European Medicines Agency (EMA) for health technologies still in the clinical development phase.

In the next few years, it is foreseeable that investment in scientific research in the area of health technologies will increase.

Data as the New Healthcare Currency and Clinical Data Intelligence

In 2022, healthcare data is a national infrastructure priority and critical business asset, attracting significant funding. This sector is producing more data in more formats across more channels than ever before. Both traditional institutional health professionals and quantified self (QS) individuals are starting to find themselves in a whole new era of massively expanded data.

A newcomer challenge has been to mine the patient’s medical record and make it readily accessible. Companies are interested in managing and accelerating regulatory filing for new medical entities to bring therapies quickly and efficiently to market. 

Taking better control of clinical trial’s data must be a priority for life sciences companies, who need information to enable researchers to develop more precision medicine and clinicians to predict patients’ response to treatments, improving outcomes and health care productivity.

To that end, pharmaceutical companies are starting to use software mechanisms to efficiently capture data from all available sources and use it to develop better treatments and launch them faster. Effectively managing this data improves and accelerates the drug development process in areas such as drug discovery, clinical trial design, patient engagement and post-market surveillance.

Many solutions have emerged offering clinical trial management software with automated, intelligent capture and AI to help organisations enhance meta-analysis in clinical trial documents. The use of clinical data intelligence allows companies to take advantage of AI technology to improve data quality, reduce time to submission and get to market faster.

Due to the plummeting cost of sequencing and Internet-based data storage, many of these data streams are now available directly to consumers.

One of the goals presented by INFARMED to the year of 2022 is precisely the use of big data, data science and artificial intelligence so we expect that Portugal will be able to develop more "intelligent" information systems.

Clinical Trials

Decentralised trials

While laboratory and plant work may require a controlled environment, there’s a range of other work that can be done remotely. Hybrid ways of working present obvious benefits for life sciences enterprise functions.

One of these examples is the adoption of decentralised clinical trials, catalysed and encouraged by the COVID-19 pandemic. Since the health-system resources became consumed by COVID-19-related care and travel became limited by physical distancing, patients’ access to trial sites decreased.

This method of conducting trials remotely and in participants’ homes is preferred by sponsors, who are continually seeking to make clinical trials faster and to improve the experience for patients and physicians. Decentralised trials offer a patient-centric approach, benefiting sponsors by accelerating clinical development, enabling more representative patient access, and developing a stronger evidence package than traditional trials.

Thus, instead of using the traditional paradigm of bringing patients to a trial site, trial decentralisation is focused on bringing trial’s activities to the patients.

This will be the future paradigm as it broadens trial access to reach a larger number and potentially a more diverse pool of patients.

Launch of the Portugal Clinical Trials Portal

Portugal aims to be more competitive in clinical research.

On the 24th of November of 2021 took place the launch session of the Portugal Clinical Trials Portal, an initiative of APIFARMA, the Portuguese Pharmaceutical Industry Association, in partnership with the Agency for Clinical Research and Biomedical Innovation (AICIB).

This new digital platform aims to contribute to the development of clinical research conducted in Portugal and, consequently, to the growth of data presented by INFARMED (epidemiological data of the country, news, clinical studies, contacts and clinical research updates).

This tool makes it possible to:

  • consult a set of global indicators that allow to obtain an overview of clinical trials in Portugal;
  • access in real time to the database of clinical trials underway in Portugal with details by pathology, region, phase and status of the study;
  • understand the main players and the most critical phases of the submission and approval process of a clinical trial in Portugal; and
  • consult accurate and up-to-date epidemiological data.

This platform asserts itself as a tool to support science and the development of more and better research centres in Portugal and wants to speed up the recruitment of people with disease, boost the speed in obtaining results and access to innovative medicines, providing greater quality of life and longevity to the population.

Industrialisation

The life sciences sector is becoming more and more industrialised.

With the ever-accelerating pace of change in the life sciences industry, a new era of competition has arrived as pharmaceutical companies feel the need to compete on their technology resources to be faster and efficient.

To meet accelerated product development cycles, the life sciences industry is seeking advanced cognitive technologies to improve the productivity, speed, and compliance of core processes. Companies also need to rapidly adjust to new ways of working in terms of connectivity, collaboration and the tools and platforms that enable them.

Besides focusing on architecture based on integrated business, technology and digital strategy, life sciences leaders are scaling their individual digital twin projects into networks of intelligent twins – living models of entire factories, product life cycles and end-to-end supply chains. These models create continuous threads of data that will soon be essential to every enterprise’s digital strategy, allowing companies to innovate, reduce costs and contain risks at deployment.

Quantified Self

A key contemporary trend emerging in big data science is the quantified self (QS), ie, individuals engaged in the self-tracking of any kind of biological, physical, behavioural, or environmental information.

Software companies have been betting on innovation through apps that are revolutionising the lives of consumers of the "genome generation" who want to know more about their genetic profile, the diseases they have or might develop, and the effectiveness of health interventions.

There is a set of technologies such as wearable devices that monitor a user and collect various analytics (such as heart rate and blood pressure, caloric intake, sleep quality, physical activity, time spent playing video games and other factors involved in personal well-being), or even information and data about themselves to get the best treatment at a time, place and cost convenient to them. Genetic testing and other services have also become popular.

Quantified-self tools are increasingly collecting more personal data of users, storing them within the cloud and starting to consolidate data from different services. These techniques often involve the gathering of what would be considered "health information" according to legal definitions and may have implications on data protection privacy.

Although health data streams can contribute to the creation of a valuable public good that is usable by all, especially because it can be used in medical-related fields to predict health patterns or aide in genomic studies, it also brings up problems related to data protection privacy issues.

A new challenge is, therefore, to explore the legal and regulatory framework for self-quantified health information and wearable devices and determines the extent to which this framework addresses privacy and other concerns that these techniques engender.

It will also be interesting to watch the development of privacy-preserving QS tools.

Medicines Advertising

Advertising of medicines is subject to the legal regime provided for in the Medicines Statute, Decree-Law No 176/2006, of 30 August 2006, and, subsidiarily, the provisions of the Advertising Code (Decree-Law No 330/90, of 23 October 1990) that establishes the rules applicable to advertising in general. Also worth mentioning is Decree-Law No 5/2017, of 6 January 2017, which establishes the general principles for the advertising of medicines and medical devices.

The latest change to the legal framework of medicines for human use, also known as the Medicines Statute, was published on 19 May 2021, and it has to do with the prohibition of advertising price reductions on medicines.

The Decree-Law No 26/2021, which came into force on 1 July 2021, determines the prohibition of all forms of advertising of discounts on the price of three types of medicines: prescription medicines, medicines subsidised by the Portuguese National Health Service or medicines containing narcotic or psychotropic substances.

Therefore, in addition to the legislation already into force concerning the prohibition of advertising of these types of medicines already provided for in the Medicines Statute, there is now a prohibition on advertising discounts on the price of medicines whose advertising was already banned.

Pharmacies are still obliged to visibly disclose relevant information in their relations with customers, which includes any discounts they grant on the price of medicines, but they shall not do so in the form of advertising to the general public.

The reasons for this legislation are related to the protection of public health, to the disadvantages in terms of competition between pharmacies and to the repercussions that discounts can have on equal access to medicines for the population.

It should be noted that, for the purposes of the scope of the prohibition established herein, advertising of medicinal products comprises any form of information, canvassing or inducement that has the object or effect of promoting the prescription, dispensing, sale, purchase or consumption, particularly by the general public, wholesale distributors and health professionals.

Opportunities for Cannabis in Portugal

The influence of foreign trends and research into the potential benefits of the use of the substance for medicinal purposes have contributed to the limited decriminalisation of cannabis for medicinal purposes in Portugal.

Whereas the recreational use of cannabis is not permitted by law (it even constitutes a crime), industrial ad medicinal use is allowed if some very specific requirements are fulfilled, and only under certain circumstances.

For the medicinal use, the regulatory framework includes:

  • Law No 33/2018 of 18 July 2018, that establishes the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes;
  • Decree-Law No 8/2019, of 15 January 2019, which regulates the activities of cultivation, production, extraction and manufacture, wholesale trade, import and export, transit, acquisition, sale and delivery of medicines, as well as the placing on the market of medicines and preparations and substances based on the cannabis plant intended for human use for medicinal purposes;
  • Ordinance No 44 – A/2019, of 31 January 2019, that establishes the mechanisms under which the price of medicines and preparations and substances based on the cannabis plant intended for medical purposes should be set.

Regarding industrial use, the Regulation No 61/94, of 12 October 1994, lays down rules on the control of the licit market in narcotic drugs, psychotropic substances, precursors, and other chemical products that can be used in the manufacture of drugs.

It is expressly provided that medicines that use cannabis as a component, are required to have an MA issued by INFARMED, under the terms of the DL 176/06, while cannabis-based preparations or substances for the manufacture of medicines are required to obtain an authorization of placement in the market under the terms of the DL 8/2019, also under the responsibility of INFARMED.

Furthermore, in January 2019, a resolution of INFARMED’s Board of Directors established the first seven therapeutic indications for preparations and substances based on medical cannabis, mostly related to pain pathologies, such as multiple sclerosis, oncology, and epilepsy.

In 2021, the Portuguese Parliament once again discussed the liberalisation of cannabis for personal use. Legislative proposals have been submitted by the Portuguese parliamentary parties Bloco de Esquerda (“Left Block”) and Iniciativa Liberal (“Liberal Initiative”) and intend to allow the consumption of recreational cannabis, without prescription, under certain circumstances.

Finally, on 5 January 2022 the Ministerial Order No 14/2022 was published to introduce the first amendment to Ministerial Order 83/2021 of 15 April 2021. The original Ministerial Order set out the requirements and procedures for granting authorisations for activities relating to the cultivation, manufacture, wholesale trade, transport, circulation, import and export of medicines, preparations and substances made from the cannabis plant.

The Portuguese legislation in force still reflects a strong concern of the legislator in providing this activity with security and strict control, not only by the competent regulatory authorities, but also by the criminal police bodies. The medicinal and industrial use of cannabis are part of a controlled system where INFARMED is the competent regulatory authority.

The penalty for trafficking (production/cultivation, distribution and sale of the substances known as "drugs") is placed at the level of those corresponding to the most violent crimes foreseen in the penal code, starting, in its simple form, that is, without aggravation, at four years of prison. Thus, according to Portuguese law, it is more serious to cultivate cannabis than to organise a kidnapping or hostage taking, or even practice a violent sexual coercion.

Nevertheless, the evolutionary steps that Portugal has taken cannot be ignored. It is important to remind that the discussion under decriminalisation or legalisation of cannabis for recreational use is not over.

The pharmaceutical industry has a vested interest that the legislation contributes to the promotion of research and clinical trials. They seek the development of medicines, their approval and subsequent introduction on the market.

At this stage, we may affirm that Portugal has started to build its own medicinal cannabis market.

New Regulations – Honourable Mentions

Given that regulations, unlike directives, are directly applicable and do not need to be transposed into national law, it is relevant to mention some of those new diplomas.

  • With the entry into force of the new Regulation on Medical Devices (EU) 2017/745 (MDR) and the Regulation on In Vitro Diagnostic Medical Devices (IVD), new rules will be applied aiming at improved vigilance, market surveillance and traceability, as well as ensuring that these products reflect the latest scientific and technological state-of-the-art. This legislation also provides more transparency and legal certainty for manufacturers and aims to strengthen international competitiveness and innovation in the sector. On 26 May 2021, the Medical Devices Regulation became fully applicable after the transition period. The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDMR), Regulation (EU) 2017/746 remains in May 2022.
  • Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use came into force on 31 January 2022. The Regulation was adopted by the European Parliament in 2014 and released in May of the same year. It was subsequently officially published in the Official Journal of the European Union on 31 July 2021 and came into force six months after that date.
  • On 28 January 2022, the Regulation (EU) No 2019/4 of the Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed ("Medicated Feed Regulation") and the Regulation (EU) No 2019/6 of the Parliament and of the Council of 11 December 2018 on veterinary medicinal products ("Regulation on Veterinary Medicinal Products (VMPs)") entered into force.

The regulations now published will allow the legal framework to be adapted to the practical reality of this sector of activity.

Conclusion

The global life sciences industry is evolving at an extraordinary rate, and we can say, with some degree of certainty, that COVID-19 was its driving force.

Health is undoubtedly the core sector of post-pandemic economic recovery and investors have not closed their eyes to this. Several changes and alterations in habits have been witnessed, motivated by the need to create quick reaction responses to future adversities. The times ahead will also be shaped by an exponential growth of industrialisation and technologies in this sector, allied to combined services from the fields of science, economics, and information technology.

The area of life sciences is therefore a strategic investment and priority area that stands out in the design of future policy measures in Portugal.

Sérvulo & Associados – Sociedade de Advogados, SP, RL

Rua Garrett
n.º 64, 1200-204
Lisboa
Portugal

+351 210 933 000

+351 210 933 001/2

geral@servulo.com www.servulo.com/en/
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PLMJ is a law firm based in Portugal that combines a full service with bespoke legal craftsmanship. For more than 50 years, the firm has supported clients in all areas of the law, often with multidisciplinary teams, and always acting as a business partner in the most strategic decision-making processes. PLMJ has specialist lawyers that know the sectors and markets they work in well, and keep in close contact with the regulators for each sector. The firm created PLMJ Colab, a collaborative network of law firms spread across Portugal and other countries with which it has cultural and strategic ties. PLMJ Colab makes the best use of resources and provides a concerted response to clients' international challenges. International co-operation is ensured through firms specialising in the legal systems and local cultures of Angola, Cabo Verde, China/Macau, Guinea-Bissau, Mozambique, São Tomé and Príncipe, and Timor-Leste.

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Sérvulo & Associados – Sociedade de Advogados, SP, RL is a Portuguese full-service law firm which occupies a leading position in the Portuguese legal market. Recognised for the quality of its legal services in all relevant areas of law and strategic sectors, SÉRVULO has a highly competent multidisciplinary team of more than 100 lawyers, motivated by a single purpose: to transform academic research and accumulated knowledge in the design of sound legal solutions, thus creating added value for its clients. SÉRVULO is trusted by a vast number of the main private and public entities, both domestic and international, in the Portuguese-speaking legal markets and in all the most significant economic sectors. It houses a roster of lawyers that are fully capable of facing all of the challenges that may arise at any time and in any field of the law. SÉRVULO’s practice areas are recognised by the main legal directories.

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