The Plenary passed a resolution calling for more affordable prices and full access to cure for all
by Emanuele Bonini
It is time to put and end to the high cost of medicines, said the European Parliament in a resolution approved in latest session of the Plenary by 568 votes to 30, with 52 abstentions. Pharmaceutical products have no-limits in price increase, making more and more difficult for people to get access to cures. The EU body thus decided to respond the needs of people by passing a text calling for measures to improve the traceability of R&D costs, public funding and marketing expenditure in name of transparency. Members of the Parliament adopted a non-legislative resolution, whose political message is however strong: medicines must be more affordable.
Barriers to medicines access. The resolution denounced how «in many cases the prices of new medicines have increased during the past few decades to the point of being unaffordable to many European citizens». All this happened despite ensuring patient access to essential medicines be one of the core objectives of the EU and the WHO. However the possibility of medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination. Such conditions are not met, the MEPs complained. «Certain essential medicines are not available in many Member States, which can lead to problems with regard to patient care». This lack of basic pharmaceutical product is supposed to be due to «illegitimate business strategies, such as "pay for delay" in the pharmaceutical sector, or political, manufacturing or distribution issues, or parallel trade».
Legal changes for the sector. The European Parliament called for changes of the EU legislation and European practices in order to fix affordable prices. First, more transparency is needed since the high level of public funds used for researche and development (R&D) is not reflected in the pricing of medicines, preventing a fair return on public investment. Secondly, there is a problem of a growth in pharmaceutical spending and «the clear» asymmetry between pharmaceutical companies and Member States in negotiating capacity which requires further European cooperation and new policy measures at both EU and national levels. Furthermore, MEPs noted «with concern» that data supporting the assessment of the added value of innovative medicines «is often scarce and not sufficiently convincing» to support solid decision-making on pricing. Again, there is in Europe an eccessive number of litigation cases aiming to delay generic entry. According to the final report of the Commission’s Pharmaceutical Sector Inquiry, the number of litigation cases quadrupled between 2000 and 2007, with almost 60% of the cases concerned second generation patents taking on average, two years to be resolved. It is time all that be over.
Recommendations. There are several recommendations in the resolution approved by the Parliament. Some of them are both for the Commission and the Council together, some others are tailor made. Starting from the "common" calls, the Council and the Commission were asked to reinforce the negotiation capacities of Member States in order to ensure affordable access to medicines across the EU. Both institutions should adopt strategic plans to ensure access to life-saving medicines. In this regards the European Parliament called for the coordination of a plan to eradicate hepatitis C in the EU using tools such as European joint procurement. About "instituion specific recommendations", the Commission was asked to propose a new directive on transparency of price-setting procedures and reimbursement systems, «taking into account the challenges of the market». At the same time the Commission should reinforce the EU competition legislation and its competencies on the pharmaceutical market in order to counter abuse and promote fair prices for patients. The Council was asked to increase cooperation between the Member States as regards price-setting procedures.
Hidden gifts to corporations? According to the Italian MEP Piernicola Pedicini (M5S/EFDD), concessions were made to the big producers by approving an amendment which allow the practice known as "incremental innovation". As he explained in his public intervention, according to the rules, when a drug patent expires companies lose their intellectual property rights. Under the incremental innovation regime, «thanks to small innovations which change the composition of the pharmaceutical product, such as for example, the addition of an excipient, the manufacturers obtain an extension of the patent which makes them monopolists "de-facto"».
It is time to put and end to the high cost of medicines, said the European Parliament in a resolution approved in latest session of the Plenary by 568 votes to 30, with 52 abstentions. Pharmaceutical products have no-limits in price increase, making more and more difficult for people to get access to cures. The EU body thus decided to respond the needs of people by passing a text calling for measures to improve the traceability of R&D costs, public funding and marketing expenditure in name of transparency. Members of the Parliament adopted a non-legislative resolution, whose political message is however strong: medicines must be more affordable.
Barriers to medicines access. The resolution denounced how «in many cases the prices of new medicines have increased during the past few decades to the point of being unaffordable to many European citizens». All this happened despite ensuring patient access to essential medicines be one of the core objectives of the EU and the WHO. However the possibility of medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination. Such conditions are not met, the MEPs complained. «Certain essential medicines are not available in many Member States, which can lead to problems with regard to patient care». This lack of basic pharmaceutical product is supposed to be due to «illegitimate business strategies, such as "pay for delay" in the pharmaceutical sector, or political, manufacturing or distribution issues, or parallel trade».
Legal changes for the sector. The European Parliament called for changes of the EU legislation and European practices in order to fix affordable prices. First, more transparency is needed since the high level of public funds used for researche and development (R&D) is not reflected in the pricing of medicines, preventing a fair return on public investment. Secondly, there is a problem of a growth in pharmaceutical spending and «the clear» asymmetry between pharmaceutical companies and Member States in negotiating capacity which requires further European cooperation and new policy measures at both EU and national levels. Furthermore, MEPs noted «with concern» that data supporting the assessment of the added value of innovative medicines «is often scarce and not sufficiently convincing» to support solid decision-making on pricing. Again, there is in Europe an eccessive number of litigation cases aiming to delay generic entry. According to the final report of the Commission’s Pharmaceutical Sector Inquiry, the number of litigation cases quadrupled between 2000 and 2007, with almost 60% of the cases concerned second generation patents taking on average, two years to be resolved. It is time all that be over.
Recommendations. There are several recommendations in the resolution approved by the Parliament. Some of them are both for the Commission and the Council together, some others are tailor made. Starting from the "common" calls, the Council and the Commission were asked to reinforce the negotiation capacities of Member States in order to ensure affordable access to medicines across the EU. Both institutions should adopt strategic plans to ensure access to life-saving medicines. In this regards the European Parliament called for the coordination of a plan to eradicate hepatitis C in the EU using tools such as European joint procurement. About "instituion specific recommendations", the Commission was asked to propose a new directive on transparency of price-setting procedures and reimbursement systems, «taking into account the challenges of the market». At the same time the Commission should reinforce the EU competition legislation and its competencies on the pharmaceutical market in order to counter abuse and promote fair prices for patients. The Council was asked to increase cooperation between the Member States as regards price-setting procedures.
Hidden gifts to corporations? According to the Italian MEP Piernicola Pedicini (M5S/EFDD), concessions were made to the big producers by approving an amendment which allow the practice known as "incremental innovation". As he explained in his public intervention, according to the rules, when a drug patent expires companies lose their intellectual property rights. Under the incremental innovation regime, «thanks to small innovations which change the composition of the pharmaceutical product, such as for example, the addition of an excipient, the manufacturers obtain an extension of the patent which makes them monopolists "de-facto"».
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