February 18, 2013 | By Márcio Barra
It looks like, while I was away, that some new changes occured in the Portuguese regulatory landscape. The law that governs medicinal products in Portugal – the Estatuto do Medicamento, or Decree-law nº 176/2006 – underwent its seventh revision, published last Wednesday in the Diário da República, and entered into force last Friday.
The revision, upheld by Decree-law n.º 20/2013, was prompted by the new European pharmacovigilance directive, which brought a lot of changes on how Member States should conduct their pharmacovigilance activities. The new revision took the feedback from major Portuguese stakeholders and players in the pharmaceutical industry, such as the order of pharmacists, order of physicians, order of nurses, the Portuguese pharmaceutical industry association, the generic drug association, amongst others. Here are the main changes:
- New definitions and clarifications on previous definitions: Mostly concerned with the new changes brought forth by the new European pharmacogivilance directive, such as the new adverse reaction definition, risk management systems, and post authorization studies. Homepathic drugs are also further explained.
- Earnings transparency: This is the biggest change. All agents of the health sector, be it physicians, scientific societies, patient associations, etc. are now obliged to publicly declare to Infarmed (the portuguese competent authority on human drugs), in a period of 30 days, all financial support, either direct or indirect, provided by the pharmaceutical industry. Failing to do so may carry fines from 2.000 to 3.750 euros if it’s an individual, or up to 45.000 euros if it’s a group of people. These details have to be sent to Infarmed through the Comunication Platform (through here), and all this information will be published online.
- More power to Infarmed: Infarmed may now, after giving a market authorization to a drug, request the market authorization holder to conduct a post marketing study, whenever there are concerns about the pharmaceutical product. After a request, the markething authorization holder has to present to Infarmed a project for a clinical trial protocol. Based on the results of the trial, Infarmed conducts proper action.
Infarmed can also, besides regular fines, enforce further, “accessory” penalties whenever the situation and the offender warrants. These accessory penalties include:
The loss of objects, equipment and devices to the State;
Suspension of all activities for a maximum of two years;
Denial up to two years of the right to participate in public contracts;
The suspension of any market authorization or other rights for a maximum of two years.
The Decree-law also states that a national drug portal, managed by Infarmed and connected to the European drug portal will be created. In this website, Infarmed will publish, among other things, each portuguese SmPC, reports of public evaluations, summaries of the risk management plans for authorized drugs and information on the different ways available both to health professionals and patients to report adverse reactions.
- Markething authorizations: All requests for a MA now have to be accompanied by a summary of the proposed pharmacovigilance system, alongside a suitable risk management plan and the schedule of the Periodic Safety Reports (PSUR). All holders of MA’s granted before July 21, 2012 are exempted from applying said system, unless Infarmed so demands.
Seems like busy days are ahead for the Portuguese competent authority. More new jobs maybe?