Parliament is calling on the European Union to improve access to medicines, including paediatric, orphan and generic medicines. In a non-legislative resolution adopted on Thursday 2 March, which reiterates the conclusions of the Council (see EUROPE 11574), MEPs presented a variety of options to tackle issues such as research and innovation, competition and transparency.
Soledad Cabezon Ruiz (S&D, Spain), who drafted the resolution, explained, “Medicines are not a consumer good. This is a question of rights and ethics. We need a legislative framework and economic and social criteria”. Her Italian colleague Piernicola Pedicini (ELDD) was outraged by some of the disproportionate prices for some innovative medicines, “Sofosbuvir costs 277 times more than its production price, while anti-whooping cough medicines cost 120 times this price”.
The 45-page resolution calls for “universal, affordable, effective, safe and swift access” to essential and innovative treatments. It calls on the Council to strengthen cooperation between member states in the area of price setting procedures, so that they can share information regarding negotiation agreements and good practices and avoid unnecessary administrative requirements and delays. At the same time, it calls on the Commission to revise the 89/105/EC directive on the transparency of measures governing the setting of prices for medicines for human use, following the 2015 withdrawal of the draft proposal. It also called for guarantees on the bringing onto the market of generic and similar biological medicines within an appropriate timeframe.
The resolution explores the issue of technological health assessments and a mechanism that can help identify the efficiency of a new technology compared to technologies that already exist and upon which the Commission is currently working (see EUROPE 11641). It calls for a legislative proposal on a European system as soon as possible, together with assessment criteria for “harmonised and transparent” medical technologies. It also requests “compulsory efficiency assessments at a European level during the first stages of the conceptualisation of new medicines” as well as “a European system for classifying the added therapeutic value of medicines”.
MEPs are also getting to grips with the difficult issue of patents and are warning against possible inappropriate use of intellectual property protection rules that help perpetuate the “evergreening” of patent rights, to avoid competition. In response, Commissioner Vytenis Andriukaitis indicated that the Commission was preparing a study on incentive schemes for pharmaceutical companies, the results of which should be available at the end of the year. He also announced a public consultation about the mechanism for extending additional protection certificates.
It should be pointed out that the report has scrapped the idea of a “contribution system in favour of an innovation fund” as this provision was rejected during the vote. (Original version in French by Sophie Petitjean)