Portugal has stepped forward to house the European Medicines Agency (EMA) currently located in London, once Brexit becomes a reality. “Portugal has technical, scientific and regulatory conditions to receive the Agency" said recently the Portuguese Health Minister Adalberto Campos Fernandes during a visit to the EMA’s headquarters in London. 

The Minister highlighted the merits of Lisbon promising the national commitment to a rapid transition that would minimize the impact on the regular activities of the EMA. “This is a logistics operation of many thousands of people. What the Agency wants is a good building, with good conditions and space to work. This is the easiest to do. But in 30 days people have to be accommodated, the kids ' school must be set and the employability for spouses/partners. There has to be a package of integration, to make life easier.”

The Minister considered that “the climate, the cost of accommodation, the existence of international schools and infrastructures in Portugal are strong arguments”, believing that it will not be easy to find equivalent conditions in other cities, namely the combination of life quality and cost of living itself, such as Lisbon provides. Other strong advantages of Lisbon are its hotel capacity, cosmopolitan culture and overall safety.

The importance of being EMA

The EMA acts as the regulatory agency deciding if pharmaceutical products are safe for the European single market as well as in the countries of the European Economic Area. Set up in 1995, EMA employs about 900 highly skilled staff, making it one of the biggest EU agencies. With its annual budget of €300 million and some 65,000 visitors to more than 500 international meetings every year it is expected that the relocation of EMA brings a positive effect for any country’s medical and pharmaceutical industry. The decision on where to move EMA is a political one and will be made by the European Council, presumably until 2019.

Other competitors

A very lively competition for the EMA relocation after Brexit is already in place.  Other countries such as the Netherlands, Germany, Ireland, Sweden, Austria, Denmark and Spain are preparing to make formal bids for the EMA. In addition to Portugal, according to the information known, for over 13 countries that have also publicly expressed their interest in hosting the headquarters of the EMA. The Portuguese Minister, however, is optimistic: “Portugal and the Portuguese have come to give evidence of their resistance, resilience and competence”.

The Decree Law 5/2017, of 6 January, approves the general principles of advertising for medicinal products and medical devices based on the European Commission guidelines established on the List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector. The principles are core ethical values for all stakeholders which aim at contributing to ensure good governance in the Health System.

According to the Decree Law 5/2017, companies that produce, distribute or sell medicinal products or medical devices should observe the principles of integrity, respect, responsiveness, accountability, moderation, transparency and collaboration.

This new law also provides for specific rules for entities of the National Health Service (NHS) and the Ministry of Health (MS), concerning the promotion, fund raising and receiving of benefits from suppliers of goods and services in the areas of drugs, medical devices and health technologies, equipment and services in the area of IT or other related matters. Exceptionally NHS and MS bodies may receive benefits from suppliers provided that such benefits are proven to not compromise their impartiality and exemption or have been duly authorised by the MS.

 The new law comes into force on 5 February 2017.

 In April 2016 INFARMED started publishing a set of Therapeutic Recommendations (TR) seeking to contribute to rationalize and increase the quality of medical prescription. The TRs will be published on a regular basis and shall focus on particular areas such as those where new scientific evidence arise or specific treatment trends that could be improved. The first TR covers the prescription of statins.

Statins are indicated for the treatment of hypercholesterolemia (high cholesterol), for the prevention of cardiovascular diseases associated to atherosclerosis. The ability to reduce total cholesterol and LDL-c differs between the various statins and depends on the dose administered. According to the TR issued by Infarmed:

- multiple studies have made it possible to establish the equivalence of LDL-c reduction of statins;
- the option of prescribers for statins that have generics reduces costs for the patient and for the Health System maintaining the same therapeutic efficacy. In particular, if half the patients currently treated with rosuvastatin and pitavastatin are treated with other generic drugs statins it would be possible to obtain savings of about 25ME in a total of 119ME spent in 2015 (over 13ME for patients and the remainder to the Health System).