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SPC waiver in operation from 1 July 2019

SPC waiver in operation from 1 July 2019

Posted on 17 June 2019

Generic and biosimilars manufacturers will soon find it easier and quicker to launch their products following publication of an EU Regulation which provides an exception to infringement of a supplementary protection certificate (SPC), known as the 'SPC waiver'. The SPC waiver will allow EU-based generic and biosimilars manufacturers to make a product in the EU for the purposes of exporting it to third countries where it may not be subject to protection. Significantly, it will also allow them to make and stockpile medicines in the six months period before an SPC expires, to allow for a Day One EU launch on that expiry date. The EU anticipates that the waiver will generate over ten years additional annual export sales of more than EUR 1 billion, leading to 20000-25000 jobs.

When will it apply?

The waiver will apply to SPCs applied for on or after 1 July 2019. It will not apply to SPCs that take effect before 1 July 2019. However, where an SPC application was filed before 1 July 2019 but does not take effect until after 1 July 2019, it will apply after a period of three years, i.e., from 2 July 2022.

How will the waiver operate?

There will be an exception to SPC infringement for acts of making a product, or a medicinal product containing that product, for the purposes of export to third countries where protection has expired or does not exist, and strictly related acts.

Further, in the six month period prior to expiry of the SPC, it will be possible to make and store (stockpile) medicinal products in a Member State - plus any strictly related acts - for the purposes of entering the market of any EU Member State on expiry of the SPC: EU Day One Entry. 

There are, however, some safeguards for SPC holders:

  • An information obligation: No later than three months before starting to make a product under the waiver, the maker must notify the relevant authority in the Member State where the making is to take place, and importantly the SPC holder. This notification will be in standard form, and will be published by the relevant authority.

The information required is:

  1. Name and address of maker
  2. Indication of whether the making is for the purpose of export, storing or both
  3. The Member State where the making/storing is to take place, and of any first related act prior to the making
  4. The number of the SPC in the Member State of making / first related act prior to making
  5. For exports, the MA reference number or equivalent in each third country of export and any updates where this information is not yet available

Obvious concerns are that this information obligation will involve disclosure of commercially sensitive information and potentially lead to speculative litigation. 

  • Labelling requirements: Where products are to be exported to third countries, the maker must ensure the required logo is affixed.
  • Due diligence requirements: The maker must comply with certain due diligence requirements. These include ensuring that those in its supply chain are fully informed and aware - including through contractual means - that the product is covered by the waiver and is intended for the purpose of export/storing as applicable, and that any acts of placing the product on the market/import/re-import might infringe the SPC.

What about Brexit?

On 5 July, the UKIPO issued a consultation (closing on 9 August 2019) which deals with the scenario of a No Deal Brexit.  In such a situation, the SPC waiver legislation will be retained as UK law on exit day but will need revising to work properly after the UK leaves the EU.  The consultation proposes to allow UK based manufacturers to make SPC-protected medicines for export outside of the UK or, in the last six months of the SPC, for storage in the UK ready for sale on the UK market after the SPC expires.  There are also proposals in relation to related acts, the notification and information requirements, and the wording to be affixed to packaging (in place of the EU's logo) etc.  There will also need to be transitional provisions to deal with the small number of SPCs which may have been applied for before 1 July 2019, and which take effect before the proposed legislation enters into force.

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