The eighth amendment to the Medicinal Products Act was published in the Official Gazette, on September 5, through Decree-Law 128/2013, being this the second amendment in 2013 to the Medicinal Products Act.
This Decree-Law transposes into Portuguese law two directives: Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, which aims to prevent the entry into the legal supply chain of falsified medicinal products and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 on pharmacovigilance.
With the transposition of the Directive on falsified medicinal products, the legislature introduced two new legal concepts, "counterfeit medicinal products" and "brokering of medicinal products". The first is defined as any medicinal product, except for the unintentional quality defects, including a misrepresentation of its identity, its origin or its history. The brokering of medicinal products is defined as any activity related to the sale or purchase of medicinal products, except for wholesale distribution, which does not include the physical manipulation and that consists of negotiating independently on behalf of another person or entity. The brokering of medicinal products must be registered within Infarmed.
The transposition of the Directive on falsified medicinal products also introduced new rules on the safety of medicinal products. Indeed, with the entry into force of the new law, the outer packaging or primary packaging of a product must contain safety devices that allow wholesale distributors and persons authorized or entitled to supply medicinal products to (i) verify the authenticity of the product and to (ii) identify each package as well as a device to check whether the outer packaging has been tampered with.
It shall also be noted within the transposition of the Directive on Falsified Medicinal Products, the amendments to the legal framework of Pharmacies2 on the sale of medicinal products on the internet, which is a matter that demands a separate regulation for a long time. Rules were established regarding the minimum information to be contained in websites offering medicinal products for sale, and also the creation of a common logo, which is recognized throughout the European Union, which must appear on all sites where medicinal products are sell to the public, which is an activity that requires prior notice to Infarmed. Additionally, it is reinforced the content of the information to be provided by Infarmed through its website, for the sale of medicinal products at distance through services of the information society and the entities that have such activity.
Regarding changes in the context of pharmacovigilance, we note the ones relating to strengthening of Infarmed‘s powers under the urgent procedure of the European Union and the rules governing the wholesale distribution to third countries. The amendment to the Medicinal Products Act in February 2013, through Decree-Law n. º 20/2013, reformed the pharmacovigilance system.
The legislature also took this opportunity to introduce the so-called "third list" of medicinal products. Indeed, a new subcategory was created of medicinal products not subject to medical prescription that may only be supplied in pharmacies, given its safety profile and its therapeutic indications. The reclassification of medicinal products subject to medical prescription into this new subcategory depends on Infarmed’s authorization. Upon approval of this measure by the Council of Ministers in June 2013, the Government released a list of 17 active substances that could be classified as Non-prescription Medicinal Products exclusively sold in pharmacies, being the these active substances still classified as Medicinal Products Subject to Prescription. The new law provides that Infarmed can define, by regulation, the medicinal products subject to medical prescription, as well as the therapeutic indications, that can be temporarily supplied exclusively in pharmacies, provided that the following conditions are met: (i) if the medicinal product is reimbursed, in this situation, it will not be reimbursed, being the product sold under a maximum price, (ii) if the medicinal products is not reimbursed, the sale shall be made under the regime of free price and (iii) the pharmacy only can supply the medicinal products without prescription for therapeutic indications, and according to the instructions that appear on protocols for the supply of medicinal products at stake, to be determined by Infarmed, having consulting the orders of Physicians and Pharmacists.
Finally, we highlight the clarification made in relation to the duty of disclosure to Infarmed on the grant and receiving of subsidies sponsorships or any other value by the pharmaceutical industry. The new law now excludes from this obligation the regular remuneration and other benefits payable under a labor agreement or a services agreement, where a services provider depends economically on the pharmaceutical company.