US IPO Lays Into EU Plans To Cut Data Protection & Extend ‘Bolar’ Exemption
The IPO says some provisions in the EU pharma revision could contravene the TRIPS agreement, including plans to suspend regulatory data protection on products subject to a compulsory licence in times of health emergencies.
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Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.
Members of the European Parliament were told that once the list was out, work would begin on identifying the products most vulnerable to supply chain problems.
Members of the European Parliament committee charged with leading the negotiations on the review of the EU pharmaceutical legislation have been presented with a study backing cuts in data protection and wider joint procurement of medicines outside emergency situations.