Representatives of the European Commission, Council and Parliament have reached agreement on a compromise text relating to an exception to infringement of an SPC for the purposes of exporting to third countries, and also, significantly, for the purposes of stockpiling medicines in the six month period before the SPC expires to allow for a Day One EU launch. The text will now be subject to final approval by the Council and the Parliament, but should then come into force fairly quickly after that approval is obtained.
In summary:
- There will be an exception to infringement of an SPC 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.
- 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). This is a shorter period than the two years proposed by the Parliament, whereas the Council had proposed no provision for EU Day One Entry.
There are some safeguards for SPC holders including:
An information obligation: The maker must notify the relevant authority in the Member State where the making is to take place, and importantly the SPC holder, no later than three months before the start date of making (or related act). The information required is in a standard form (annexed to the draft Regulation), and it will be published by the relevant authority. The authority may charge a fee for filing the notification.
The information required is:
- Name and address of maker
- Indication of whether the making is for the purpose of export, storing or both
- The Member State where the making/storing is to take place, and of any first related act prior to the making
- The number of the SPC in the Member State of making / first related act prior to making
- For exports, the MA reference number or equivalent in each third country of export
Medicines for Europe has criticised the requirement to notify the SPC holder as "unnecessary and redundant", and is concerned that it will mean disclosure of commercially sensitive information and potentially lead to frivolous litigation. The draft Regulation states: "the information is limited to what is necessary and appropriate for the certificate holder to assess whether the rights conferred by the [SPC] are being respected, and does not include confidential or commercially sensitive information".
Labelling requirements: Where products are to be exported to third countries, the maker must ensure the required logo is affixed (annexed to the draft Regulation).
Due diligence requirements: The maker must comply with certain due diligence requirements including ensuring those in its supply chain are fully informed and aware (including through contractual means) that the product is covered by the exception 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.
When will it apply:
- The exception will not apply to an SPC that has already taken effect at the date of entry into force of the proposed Regulation.
- It will apply to SPCs applied for on or after the date of entry into force of the proposed Regulation.
- It will also apply, as from 1 July 2022 (this date is intended to be three years after the date of entry into force of the proposed Regulation so may change), to SPCs applied for before the date of entry into force of the new Regulation but which have not taken effect before the date of the new Regulation entering into force. The point behind this is to allow the holder of a granted SPC that has not yet taken effect by the date the new Regulation enters into force a period of transition to adapt, whilst also allowing makers of generics/biosimilars to benefit, without excessive delay, from the exception.
As noted in the Council's press release, the draft regulation is projected to generate, over the next ten years, "additional net annual export sales of well in excess of EUR 1 billion, which could translate into 20 000 to 25 000 new jobs over that period."