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Latest changes to the SPC Regulation - manufacturing waiver


United Kingdom

The new SPC manufacturing waiver allows companies to manufacture generics and biosimilars prior to the expiry of an SPC for export to a non-EU country where protection has expired or never existed, or for stockpiling during the final six months of an SPC ahead of entry into the EU market.

On 1 July 2019, amendments ((EU) 2019/933) to the SPC Regulation ((EC) 469/2009) introducing a manufacturing waiver came into effect.

These amendments allow EU-based companies to manufacture a generic or biosimilar version of an SPC protected drug, during the term of the relevant SPC, for the specific purposes of:

  • exporting to a non-EU market where protection has expired or never existed, or
  • stockpiling during the final six months of an SPC, in order to facilitate entry into the EU market immediately upon expiry of the SPC.

Manufacturers will need to provide the SPC holder and the intellectual property office which granted the SPC with details regarding its proposed activities three months prior to manufacture, or any other act which would otherwise be prohibited by the SPC. They will also need to affix the following logo to drugs manufactured for export to a non-EU market:

The manufacturing waiver will apply to all SPCs applied for on or after 1 July 2019. In the case of SPCs applied for before that date, the waiver will only apply from 2 July 2022 onwards. SPCs which took effect before 1 July 2019 remain unaffected.

The European Commission hopes that the waiver will "help EU-based pharmaceutical companies tap into fast-growing global markets" and prevent generic and biosimilar manufacturers from moving out of the EU. It predicts that the waiver could generate more than €1 billion net additional sales per year and up to 25,000 new jobs over 10 years, and improve patients' access to a wider choice of medicines, therefore alleviating public budgets.

However the introduction of the manufacturing waiver was not without opposition. Certain member states, such as Denmark, expressed concerns regarding the potential impact of the waiver on drug research and development in the EU. The UK also voted against the amendments.

No-deal legislation

If the UK leaves the EU without a deal, these amendments to the SPC Regulation will automatically be incorporated into UK law on exit day (like all EU law in force in the UK). Certain of the amendments will require fixing to continue working as UK law, and the UK IPO is currently seeking views on how it proposes to make those fixes. The consultation runs until 9 August 2019.

For further information on SPCs generally in the event of a no-deal, see our earlier blog: No-deal patents and SPCs: latest government guidance - the picture is not as clear as it might at first seem.

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