New rules that will boost the export of generic medicines and biosimilar products to third countries got the stamp of approval from the EU’s 28 ambassadors after they agreed to adopt the European Council’s draft regulation on manufacturing waivers that allow EU-based companies to manufacture generic or biosimilar versions of pharmaceuticals if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed.
The exception, according to the agreement reached between the EU’s 28 members, will operate only where generics or biosimilars are produced exclusively for export to third countries where the protection of original medicine does not exist or has expired.
If the maker has provided the information required by the regulation to both the authorities where it is produced. If the producer has duly informed all those involved in the commercialisation of the product, it can then be put on the market only outside the EU.
The maker should also affix to the packaging a specific logo provided by the regulator indicating clearly that it is only for export.
The draft regulation aims to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets.
The regulation will affect only those pharmaceuticals that are applied for on or after the date of entry when the regulation comes into force. The regulation also applies to products that have become effective after the regulation became official.
The European Parliament is expected to agree on negotiating a mandate and grant the Romanian presidency the right to start negotiations. Both the Council and the Parliament want to adopt the regulation at first reading, before the European elections in May.