Two reforms to redesign the pharma market

Two fundamental reforms by the EU Commission, if approved, could redesign the scenario for the development, production and sale of drugs in Europe. The former concerns the review of pharmaceutical legislation and a European Council’s recommendation about antimicrobial resistance. The latter regards intellectual property, in particular the unity of the SPC (supplementary protection certificates) and the activation of compulsory licenses in the event of public health emergencies. The two reforms have various interconnections and must in any case be submitted to the scrutiny of the Parliament (which will be renewed in 2024) and the European Council. But the debate is already underway, especially among insiders, who have already expressed comments and a few criticisms through the main industrial associations, although with different positions on individual issues. One of the main objectives of the draft regulation reform is to boost a truly unique pharmaceutical market, for instance by rewarding companies that launch a new product simultaneously in all member states, thus overcoming the current fragmentation, largely due to the choice of manufacturers to focus on the most profitable markets or where there are the best conditions in terms of prices and reimbursements. The new measures, which also try to provide answers to the needs arisen in times of pandemic, aim at speeding up the arrival of new drugs on the market, reducing the EMA evaluation times from the current aver age of 400 days to 180 and 150 in case of health emergencies. Monitoring of possible shortages of critical med icines and vulnerabilities in sup ply chains is also being pushed. The experience of the pandemic has also affected the propos als on intellectual property, with the introduction of compulsory licenses in the event of public health emergencies, which would come into play as a last resort and in a centralized way in Europe, again in the per spective of less regulatory fragmentation. Some industrial associations, while highlight ing positive aspects, underline the risks for the future of continental research and devel opment due to the reduction of the regulatory protection period, as well as the difficulty of simultaneously launching products in all EU countries. Compulsory licenses are also under scrutiny, which according to Efpia would not al low companies to choose the partners deemed most reliable. The path of reforms has therefore begun, but it promises to be certainly not with out pitfalls. covers, covers and joint covers, which are tailored with types of materials and fabrics that are suitable not to be contaminated and degraded by fluids passing inside the plant.

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