Since 1 July 2019, the protection that an SPC gives to medicines no longer extends to manufacturing for export outside the EU or for storage in the 6 months preceding the expiry of the SPC, under certain conditions.
What are the limits and conditions of application of the exemptions introduced by the entry into force of the Regulation amending EU Regulation 469/2009?
EU Regulation 2019/933 of the European Parliament and the Council of 20 May 2019, published in the EU Official Journal on 11 June 2019, came into force 20 days later, on 1 July 2019. Voted on 17 April 2019 by the European Parliament, it was the result of discussions and a legislative process, which we told you about here.
The stated objective of this regulation is to foster innovation in the European Union (EU) and to promote the competitiveness of the EU. Manufacturers of generic and biosimilar medicines established in the EU are now entitled, under certain conditions, to manufacture or to store products or medicines covered by an SPC (supplementary protection certificate) for export to non-EU countries.
According to the EU Council press release, the regulation “will help new pharmaceutical companies start up and scale up in high growth areas, and is projected to generate, over the next 10 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 ».
Regulation EU 469/2009 relating to the SPC aims to compensate for the delay between filing a patent protecting a medicine and obtaining the Marketing Authorisation which reduces the duration of the patentee’s actual operating monopoly. The SPC extends the protection of a product (active ingredient or composition of active ingredients) by a maximum of five years from the expiry of the maximum period of validity of the patent. This period may be extended by a maximum of 6 additional months if the medicinal product is authorised for a paediatric indication (EC Regulation no. 1901/2006 ).
In its Article 5, EU Regulation 2019/933 introduces two exceptions to the effects of the SPC, which does not give protection to :
- The manufacture of a product or a medicine containing it for the purposes of export to non-EU countries;
- The manufacture, during the 6 months preceding the expiry of the SPC, for the purposes of storage in the Member State where the manufacture takes place, in order to a bringing to market in the Member States after the expiry of the corresponding SPC.
These exceptions extend to the related acts that are strictly necessary for carrying out the above manufacturing actions.
However, the exception does not apply to the import of products in the EU merely for the purpose of repackaging, re-exporting or storaging.
Management of the exception: Mandatory information relating to the manufacturing actions by the manufacturer wishing to benefit from it, the holder of the SPC and authorities in the Member State
- The manufacturer must notify the authority in the Member State (namely the competent department of the industrial property for which the SPC has been filed) at least 3 months before the start of manufacture or before the first related action prior to manufacture. Notification forms provide that the information communicated shall include the identity of the manufacturer, the Member State or States in which the manufacture (and, where appropriate, storage) takes place, the references of the relevant SPCs and those of the MA for the countries where the export is planned.
This information will be published as soon as possible by the authority.
- The manufacturer must directly communicate the information to the holder of the SPC
- If this information is modified, the holder must inform the competent authority and the holder of the SPC
The information provided will be used by the holder of the SPC to verify compliance with the requirements of the Regulation and, where appropriate, to initiate legal action in the event of non-compliance.
A logo will have to be affixed onto the packaging of the product or medicinal product manufactured for export.
Gradual entry into force of the exceptions: the new provisions do not apply to SPCs which took effect before 1 July 2019.
SPCs that took effect before the entry into force of the Regulation are not affected by these exceptions.
In addition, a transitional period of 3 years is planned for SPCs already deposited but that have not yet taken effect on 1 July 2019. The new provisions will apply from 2 July 2020.
The amended regulation applies to all SPCs filed from 1 July 2019 (entry into force of the scheme).
An evaluation of the impact of these provisions is planned for 5 years’ time, then every 5 years thereafter.
The new Article 21a inserted in the SPC Regulation stipulates that the Commission shall carry out an evaluation of the impact of the exception of making for the purposes of storing or export , on access to medicines and public health expenditure after the expiry of the corresponding certificate.
In particular, the evaluation will focus on whether the 6 month period preceding the expiry date to authorise the storage with a view to a bringing to market in the Member States is sufficient for achieving the objectives set, in particular the market entry from the 1st day after certificate lapses taking into account the impacts on public health.
As part of the evaluation, the Commission will have to ascertain whether the generic and biosimilar manufacturing that took place previously outside the Union is transferred to the territory of the Union. It will also have to study the impact of the exception on the research and production of innovative medicines in the EU by SPC holders and consider the balance between the different interests at stakes.
The proposed amendment to the regulation was supported by the “Medicine for Europe” association, which groups together manufacturers of generics and was subject to negotiations that sought a compromise between the interests of the various stakeholders. This therefore removes the risk of the SPC and the duration of its protection being called into question and the safeguards (notifications, logo affixing) should reassure rights holders. Nevertheless, the introduction of the exception for storage purposes, which was not included in the draft regulation published in May 2018, gives rise to strong reservations by associations such as LEEM in France or EFPIA (European Federation of Pharmaceutical Industries and Associations). On the other hand, GEMME (French manufacturers of generic and biosimilar medicines) welcomed the announcement of the vote for the regulation by the European Parliament.
There is no doubt that the parties whose interests – sometimes contradictory – are at stake, will be mindful of the consequences of these measures and to their assessment by the Commission, which may lead to some of the exceptions or deadlines being called into question.