The changes to EU medicine regulations

The European Union is now promoting a waiver to all manufacturers of generic drugs. This could mean that bigger pharmaceutical companies will adversely object to allowing more generic manufacturers of protected specials medicines to market outside the bloc. The European commission is proposing that the patent protection rules which currently squash competition for medicine in the markets anywhere outside of the EU should change.

The patent protection rules are not under scrutiny after the European Union has advocated for them to be changed. This would increase competitive prices for protected medicines that circulate in markets outside of the EU. The commission in question itself says that it hopes to welcome an “export manufacturing waiver”.

This would protect the pharmaceuticals sector that we know better as the supplementary protection certificates or the SPC. An SPC is known to be something of an EU-wide intellectual property whose rights reach out to include the protection of patented medicine for a maximum of five years. Supplementary protection certificates will adequately make up for patent holders’ lost time waiting to receive the standard regulatory approval that is needed for all medicines.

The current EU legislation means that any manufacturers who were based in Europe were being prevented in producing any medicine. This legislation hindered the production even if they were manufacturing products to places outside of the EU at a time where the SPC was in place. Even though these areas were not subject to the supplementary protection certificate at the time it happened, or if it had expired already, they were still prevented from moving forward.

The Irish Pharmaceutical Healthcare have been extremely forthcoming around these issues and have spoken out publicly to say that the changed that are being proposed “would be a setback for an industry centred on innovation when the focus should remain on creating the best conditions required for the discovery and delivery of new medicines and the attraction of fresh investments to Ireland”.

They furthered this by adding that “Patients rely on industry innovation for the discovery and delivery of new medicines… we must guard against any moves, including the proposed introduction of manufacturing waivers, that could weaken our ability to support the work of the originator companies in the biopharma sector.” as the regulations have only been proposed at this stage, there is remaining speculation that the changed won’t end up happening and things will stay the same as they currently are.

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