Belgian Body Welcomes Clawback Exemption For Generics/Biosimilars Amid Price Cuts
Belgian body Medaxes is content with the latest pharmaceutical pricing legislation in the country, which cuts generics and biosimilars prices but also exempts such drugs from pharmaceutical clawback taxes.
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Belgium is to impose new reporting obligations on pharmaceutical companies that become aware of drug supply interruptions, in a move that is seen by suppliers as less draconian than measures taken in other European countries.
Legislation that has just been adopted by the Belgian parliament is aiming to tackle shortages by requiring companies to notify local authorities of supply interruptions within three working days, as well as giving pharmacists the option to substitute equivalent alternatives to products in short supply. The new measures limit the risk of excessive sanctions for suppliers, according to local industry association Medaxes.
Accord Healthcare has garnered the first positive opinion recommending granting a pan-European marketing authorization for a generic version of rivaroxaban from the EMA’s CHMP. However, originator Bayer claims that no generic competition will be possible for another three years.