HEALTH & PHARMACEUTICAL INDUSTRY
Being a sector of activity under the jurisdiction of regulatory entities, such as INFARMED, Directorate-General for Economic Activities, the Competition Authority and INPI, it becomes a very complex sector, where we have consolidated experience in very different matters linked to this sector, where we intervene in all relevant topics in this area, namely the responsibility of Healthcare Professionals (medical liability, among others) in the civil, contractual, extra-contractual and criminal aspects.
The provision of legal services in the area of Health and Pharmaceuticals encompasses a transversality of knowledge in different areas of knowledge of Law, such as competition, patents and trademarks, tax, public contracting, labor, regulatory, Arbitrations required under Law no. 62/2011, of December 12th.
In the pharmaceutical industry, our Clients range from the area of medicines and medical devices, to their distributors, through the cosmetics industry, or even in the production, research and development of preparations and substances based on the cannabis plant for medicinal purposes, Public Hospitals and Private, companies and groups of companies in the pharmaceutical, health and biotechnology sectors and foundations.
We provide legal advice on:
- public procurement
- support advice
- advice on hospital subsidies and funding
- patent and trade mark protection
- patent infringement proceedings
- nullity actions
- data protection and privacy
- tax advice
- representation and defence in judicial and administrative proceedings
- competition law
- drafting and reviewing manufacturing and distribution contracts
- obtaining strategic international patents
- acquisitions
- spin-offs
- mergers
- restructuring of groups of companies
- venture capital investments
- public offerings of securities
MAIN AREAS OF INTERVENTION
- Regulation and Regulation with the Regulatory Authorities (INFARMED, National Authority for Medicines and Health Products, National Institute of Industrial Property, Competition Authority and General Directorate of Economic Activities)
- Pharmaceutical Industry (Pharmaceutical Sector Associations)
- Cosmetics & Food Supplement Industry
- Licensing of activities
- Commercial Policies
- Producer Civil
- Responsibility Pharmaceutical
- Patent Law
List of services
Extraordinary contribution to the pharmaceutical industry - OE 2024
The extraordinary contribution on the pharmaceutical industry, whose regime was approved by article 168 of Law no. 82-B/2014, of December 31, remains in force.
Pursuant to article 168 of Law no. 82-B/2014, the following is provided:
Contribution to the pharmaceutical industry
The regime that creates the extraordinary contribution on the pharmaceutical industry is approved with the following wording:
«Article 1.
Object
1 - This regime creates an extraordinary contribution on the pharmaceutical industry, hereinafter referred to as contribution, and determines the conditions of its application.
2 - The contribution focuses on the volume of sales and aims to guarantee the sustainability of the National Health Service (SNS) in terms of expenditure on medicines.
Article 2.
Subjective incidence
Entities that carry out the first disposal for consideration, in national territory, of medicines for human use, whether they are holders of authorization, or registration, for placing on the market, or their representatives, intermediaries, wholesale distributors or just sellers of medicines under authorization for exceptional use, or exceptional authorization, of medicines.Article 3. Objective incidence1 - The contribution is levied on the total sales of medicines made in each quarter, in relation to:a) Medicines reimbursed by the State in their price;b) Medicines subject to restricted medical prescription;c) Medicines that have authorization for exceptional use or exceptional authorization;d) Medicinal gases and derivatives of human blood and plasma;e) Other medicines whose packaging is intended for consumption in hospitals;f) Orphan medicines.2 - For the purposes of the previous paragraph :a) In the case of reimbursed medicines, the sales value subject to the contribution corresponds to part of the sale price to the public, deducted from the value added tax (VAT) and the tax on the marketing of medicines (TSCM), corresponding to the State's contribution to this price;b) In the case of medicines referred to in paragraphs b) to f) of the previous paragraph, the value of sales subject to the contribution corresponds to the price, deducted from VAT and TSCM, which is lowest among the following:i) Public sale price, when applicable;ii) Maximum price considered appropriate for the medicine, in accordance with paragraph c) of paragraph 4 of article 4 of Decree-Law no. 195/2006, of October 3 , amended by Decree-Law no. 48-A/2010, of May 13, when applicable;iii) Lowest sales price, net of discounts and other commercial conditions, effectively and demonstrably practiced, by the taxpayer, in the sale to SPMS - Shared Services of the Ministry of Health, EPE, regional health administrations, hospitals and other establishments and services of the SNS, in the 12 months immediately preceding.3 - The taxpayer must create conditions at all times, upon request from the authority competent authority and within the deadline set by it, present proof of the fact provided for in subparagraph iii) of paragraph b) of the previous number. 4 - The research and development expenses to which they refer are deducted from the value of the contribution referred to in this article. paragraphs 3 and 4 of article 5 of Decree-Law no. 23/2004, of January 23, as long as they are carried out in national territory and owed and paid to Portuguese taxpayers and up to the limit of the contribution.