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Spanish authorities back plans to promote patent-free medicines

Drugs packet

Competition authorities in Spain have backed plans to introduce more generic and biosimilar medicines with the aim of increasing competitiveness in the pharmaceuticals market.

In a new report (32-page / 706KB PDF), the National Commission on Markets and Competition (CNMC) has endorsed an action plan published by the Spanish Ministry of Health in April. It has, however, made several recommendations to improve the Ministry of Health's proposals, with a particular focus on improving competition in the market as a whole, with greater involvement from patients and civil society as well as healthcare personnel.

"The CNMC believes that the introduction of generic and biosimilar medicines is essential in a market with a limited competitive margin, strongly regulated and with a tendency towards concentration," said regulatory law expert Javier Alagόn of Pinsent Masons, the law firm behind Out-Law.

Javier Alagόn


Biosimilar and generic medicines promote reduced health expenditure with the same guarantees of quality, safety and efficacy, as well as pharmaceutical innovation.

"Biosimilar and generic medicines promote reduced health expenditure with the same guarantees of quality, safety and efficacy, as well as pharmaceutical innovation. This makes them useful tools to regulate the market," he said.

In its original report, the Ministry of Health recommended decreasing the minimum term for which Spain's national health system must use any particular medicine, and increasing its use of generic and biosimilar medicines. The report also recommended developing incentives to promote the production of generic and biosimilar medicines, and increasing the amount of published scientific testing and evidence about generic and biosimilar alternatives in order to increase public confidence in their use.

The CNMC has backed these proposals, concluding in its own report that generic and biosimilar medicines create a great change to boost competition and cut prices. However, it has recommended that the Ministry of Health take a more holistic approach to improving competition, in order to target the pharmaceuticals market as a whole.

The CNMC would like to see less of a focus on price regulation, with any price regulation mechanisms imposed made more flexible in order to better respond to the market and allow for greater discounts. Price caps should also be kept under review, and the potential to discourage further innovation considered. It has also recommended aggregating the purchasing power of the public sector in order to obtain better prices for patients and promoting the commercialisation of generic and biosimilar medicines in cases of price equality with branded medicines.

Doctors should be provided with more information about generic alternatives, to assist them when prescribing to patients, according to the CNMC. Measures aimed at pharmacists and dispensers should refer to drugs by their generic names rather than brand names according to the CNMC, which noted that established brands have a competitive advantage in the marketplace.

More research into the current market situation and use of generic and biosimilar medicines is also required before interventions can take place, so that the effectiveness of those interventions can be better measured. This review should include analysis of market structure, operator sizes, concentration levels, competitive dynamics, the innovation cycle and the impact of past regulatory interventions, according to the CNMC.

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