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The EU is implementing policies to give patients easier access to cheaper, generic medicines, which could cut the revenues of big pharmaceutical firms.
According to an EU document yet to be published, the European Commission (EC) will consider targeted policies that support a greater generic and biosimilar competition to make drugs more affordable and preventing dramatic shortages.
The EU will apply its antitrust rules more strictly to stop patent-holding pharmaceutical firms from hindering the entry or expansion of generic and biosimilar competitors who offer more affordable medicines.
Among the EU’s possible actions, expected in 2022, is the implementation of clearer provisions for the conduct of trials on patented products to support generic marketing authorization applications.
The EU will also renew incentives and obligations for pharma firms to allow wider distribution and greater competition.
This could require drugmakers to make their patented drugs available in all 27 states in the EU, including smaller countries that big drugmakers find less profitable, or risk shortening the period of their intellectual property rights.
Among medicines that are in short supply or unavailable in the EU are antibiotics and drugs for children and rare diseases.
Shortages in the bloc worsened during the first phase of the pandemic amid export bans and other trade restrictions and when India curbed the export of paracetamol.
