Clinical trials are a universally recognised method of performing research and development activities. The COVID-19 pandemic has made clinical trials even more important, particularly to bring effective drugs to combat the disease to the market as soon as possible. The National Authority for Medicines and Healthcare Products has published various measures which aim to mitigate the risks that the pandemic may pose to patients who participate in clinical trials.
In Portugal, those who wish to place cannabis-based medicinal preparations and substances on the market must obtain a marketing placement authorisation (MPA) from the National Authority for Medicines and Healthcare Products. The preparations or substances may then be sold in pharmacies subject to medical prescription. This article answers questions regarding how to obtain an MPA.
In the past three years, significant changes have been made to the legislation that governs the medicinal use of products, substances and preparations based on the cannabis plant. This article answers some of the most important questions regarding the licensing of certain activities involving these products, substances and preparations.
The rapid spread of COVID-19 has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. In view of this and the circumstances of the pandemic, Decree-Law 14-E/2020 was published to establish exceptional and temporary arrangements for the manufacture, import, placement and availability on the market of MDs and PPE.
The recently published act to transpose the General Data Protection Regulation into Portuguese law was expected to provide specific grounds for the processing of health data for insurance purposes. However, the act was approved without any exemptions or provisions regarding the legitimate basis on which insurers can process health data (or any other special category of data) for insurance purposes. This article examines the implications of the new law for the insurance industry.
The Arbitral Court recently issued a landmark decision regarding value added tax (VAT) deductions for holding companies. The court's approach is notable for its analysis of European Court of Justice guidance on VAT deductions for holding companies set out in several relevant decisions and its innovative approach of combining the relevant reasoning behind these decisions to provide a comprehensive legal overview.
The Lisbon Court of Appeal recently found that the trademark BELCANTO, used by the Belcanto restaurant in Lisbon, was a "trademark with a reputation" and another party's application to register the trademark to sell wines. The judgment shows that Portuguese case law is departing from the mere quantitative parameters of assessing the reputation of a trademark to focus on the relevance of a mark's national and international recognition.
The new Industrial Property Code recently entered into force with a number of amendments resulting from the implementation of the EU Trademark Regulation. Most of the changes represent a real break with the previous legal framework. The main changes concern trademark registration, the scope of rights conferred by patents and limitations on the subject matter of utility models.
In a time when corporate investment is struggling with the legal uncertainty deriving from systematic changes to the Portuguese tax system, the Constitutional Court has an important role in reassuring corporate taxpayers that the most basic constitutional principles are respected, thus protecting their investments. Three recent cases brought before the court were ultimately decided in favour of the protection of the legitimate expectations of investors and the judicial interpretation and application of the law.
The South Administrative Central Court recently discussed the problem of the admissibility, for accounting and tax purposes, of the depreciation and amortisation of submerged lands within a concession agreement between a company and the Portuguese state relating to the use of a public hydro domain for watering and hydroelectric exploitation. The court concluded that no contradiction existed between the applicable accounting and tax rules.
A recent Portuguese Supreme Administrative Court jurisprudence uniformising decision held that the statute of limitation period of an insurer's subrogated right had started only when it had paid the damages incurred by the insured due to a motor accident. The decision is a relevant milestone in administrative jurisprudence, as there are divergent opinions in this regard.
The government recently presented its 2019 Budget Law Proposal, which includes several measures for the energy sector. As per the proposal, energy sector extraordinary contributions will be levied on generators operating renewable energy power plants licensed under the guaranteed remuneration scheme, which to date had been exempted from paying such contributions.
The Portuguese Tax Administration recently concluded that payments received for the sale of 'standard software' (ie, software not subject to any customisations) do not fall within the scope of Article 12 of the Organisation for Economic Cooperation and Development (OECD) Model Convention. Instead, the right to tax income deriving from such payments falls within the purview of the beneficiary of such payments' state of residence under Article 7 (business income) of the OECD Model Convention.
The Portuguese insurance regulator recently entered into an agreement with Portugal Fintech – a network focused on start-ups that connects fintech founders, investors, academics, consultants and legal advisers – to establish Portugal Finlab. From an insurance regulatory perspective, Portugal Finlab will be a useful tool to ensure an appropriate balance between innovation and consumer protection in the insurance sector.
Although the 2008 financial crisis triggered further legislation to protect banking clients and investors, the relationship between banks and customers had been a focus of legislators and regulators long before the banking collapse. Rules and regulations in this regard concern deposit compensation, bank-client relationships, consumer complaints, breaches of contract, residential mortgage loans and minimum information duties.
A number of amendments were recently made to the Insurance Supervision Act in the context of transposing the EU Markets in Financial Instruments Directive. The main amendments concern the protection of communications to the Portuguese insurance regulator regarding violations, the imposition of fines on insurers that violate the EU Benchmarking Regulation and the rules applicable to insurers' marketing of insurance products linked to investment funds.
Pursuant to the State Budget 2017, the liquefied petroleum gas, petroleum-derived products and biofuels sectors, which were previously under the National Fuels Market Authority's supervision, are now subject to the Energy Services Regulatory Entity's (ERSE's) supervision. Minor changes have also been made to the ERSE's consulting bodies.
The Banking Law establishes that the management and supervisory bodies of credit institutions in Portugal are responsible for defining, overseeing and implementing adequate governance to ensure the institutions' effective and prudent management, including the segregation of duties and the prevention of conflicts of interest. Further, banks must disclose information regarding the remuneration of corporate bodies and employees to the Bank of Portugal or the Single Supervisory Mechanism.
Following the 2008 banking crisis, the Banking Law was amended to protect depositors of all credit institutions and safeguard the stability of the EU banking system as a whole. Under the law, the Bank of Portugal may apply a number of resolution measures to failing institutions which do not involve obtaining prior consent from their shareholders or a third party. It can also create a resolution fund, which aims to provide financial support for the implementation of measures to help failing credit institutions.
Under the General Data Protection Regulation, the processing of health data for insurance purposes requires the data subject's 'explicit consent', which poses enormous challenges for the insurance industry. Portugal has no specific legislation concerning the processing of health data for insurance purposes. However, it is hoped that the anticipated Data Protection Act will provide specific grounds for the processing of such data in this context.