A wind of change in Hungarian pharmaceutical regulations — a welcome breeze of fresh air or an unpleasant gale?

On 8 July 2013, a new Hungarian law entered into force affecting the pharmaceutical sector. The new law brings about substantial changes for the industry and has sparked some heated debate.

On the one hand, policymakers stress the need for enhanced safety and quality control of medicines as well as reduction of costs in the healthcare system. On the other hand, the industry will be subject to wider-reaching powers of the Hungarian regulator to conduct unannounced inspections, allowing for only limited means of defence. Marketing authorisation holders will be put under a new obligation to supply wholesalers whenever necessary to satisfy national demand. Also, and in most cases, they must offer the lowest EEA price in order to secure a place for its medicines in the reimbursement system. Failure to comply with the new rules exposes pharmaceutical companies to substantial fines amounting up to HUF500m (approximately €1.7m).

This alert discusses whether this ‘wind of change’ in pharmaceutical regulation in Hungary is a welcome breeze of fresh air or whether it represents a more of an unpleasant gale that will lead to more confusion than certainty…

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