Regulation (EU) 2019/933 (MW-Regulation) amending the SPC Regulation EC/469/2009 to introduce a manufacturing and stockpiling waiver for EU-based generic and biosimilar manufacturers has now been in force for almost a year. In previous articles, we have examined the privileged activities and questioned the (real) possibility of a day-1 entry under the MW regulation. Nevertheless, many questions remain unanswered. This overview examines the information obligations under the MW-Regulation and its consequences. 

Who is in charge?

The "maker" is responsible for the timely provision of the necessary information to the respective persons or authorities under the MW Regulation. The MW Regulation defines the "maker" as the person established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing is carried out (Art. 1 MW-Regulation). Therefore, the "maker" according to the MW Regulation is typically the holder of the respective marketing authorization but not others in the supply chain. 

Who is to be informed and how?

According to the MW Regulation (Art. 2, para. 2 (b), para. 5):

"…the maker, through appropriate and documented means, notifies the industrial property office of the Member State which granted the basic patent and in which the authorisation to place the product on the market as a medicinal product was obtained ("authority"), unless the Member State designates another authority for the purpose, and informs the certificate holder no later than three months before the start date of the making in that Member State, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier, (a) the name and address of the maker; (b) an indication of whether the making is for the purpose of export, storing, or both;(c) the Member State in which the making, storing and, if any, the first related act, prior to that making is to take place; (d) the number of the certificate granted in the Member State of making, and of the first related act, if any, prior to that making; and (e) for exports to third countries: the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available."

If there are changes in the information to be provided, the maker has to inform the authority as well as the certificate holder of the changes before those changes take effect (Article 2, para. 2, no. 2 (c)). 

For notifications to the authority (including information on changes), the maker has to use a standard notification form contained in Annex –Ia MW Regulation (Article 2, para. 6). It is also possible to use this form for notifications towards the certificate holder (Recital 15 MW Regulation). Where making takes place in more than one Member State, a notification is required in each of those Member States (Recital 14 MW Regulation).

In addition, the authority is required to publish, as soon as possible, the information received, together with the date of notification of that information (Recital 14 MW Regulation). Member States are also allowed to require that notifications, and updates to notifications, are subject to the payment of a one-off fee (Recital 14 MW Regulation).

Further due diligence requirements

The maker's information obligations are not limited to authorities and the certificate holder; the MW Regulation also imposes information obligations on the maker concerning its own contracting parties.

In that regard, the maker has to ensure, through appropriate and documented means, that any person having a contractual relationship with them and performing privileged acts under the MW Regulation is fully informed and aware that these acts are privileged under the MW Regulation and that the placing on the market, import or re-import of the respective products or medicinal products could infringe the relevant certificate (Art. 2, para. 9). 

According to Recital 20 MW Regulation, the "maker" has to inform persons within its supply chain in the EU, including the exporter and the person carrying out the storing, through appropriate and documented means, in particular contractual means, that the product, or the medicinal product containing that product, is covered by the exception provided for in the MW Regulation and that the making is intended for the purpose of export or storing. 

Consequences of non-compliance

As set out in Recital 14 MW Regulation, the acts mentioned in the MW Regulation are only privileged if the maker complies with the notification and information obligations regarding the authority and the certificate holder under the MW Regulation.

Failure to comply with the requirement that for exports to third countries the reference number of the marketing authorisation (or its equivalent) in each third country of export has to be provided however only affect export to that country, so that only those exports do not benefit from the exception.

A maker who fails to comply with the due diligence requirements regarding the persons having a contractual relationship with them and performing privileged acts under the MW Regulation does not benefit from the exception, nor does any third party performing a related act in the Member State of making or in a different Member State in which a certificate conferring protection for the product is in force (Recital 20 MW Regulation). 

In this case, the certificate holder may enforce its rights arising from the certificate (Recital 20 MW Regulation). This may allow the certificate holder to take legal action against both, the maker as well as against persons in his supply chain or contract workers for a mere breach of this information obligation within the supply and/or manufacturing chain for infringement of the certificate.

Open questions

Despite this extremely small-scale and detailed design of the provisions on notification and information obligations, many questions remain open and will probably only be answered by the courts. 

For example, the MW Regulation does not say anything about whether the notification and information obligations can already be fulfilled before the expiry of the basic patent of the respective SPC. If this would not be the case, the MW Regulation would be useless, at least for SPCs with a duration of less than three months, and the mere notification would not affect the rights of the patent holder. Whether courts see this in the same way remains to be seen in the future.

The courts will also have to answer the question how exactly the maker can meet its due diligence obligations in the supply chain, that is whether for example contractual guarantees or even penalty clauses are necessary or contractual (counter-signed) information is sufficient.

In any case, the current situation with the corona virus has shown how important it is to have fundamental possibilities for the production of pharmaceuticals in Europe.