BIOCIDES
‣ resources for companies , and to companies having to drop support for some products due to the unforeseen investment demands . On top of all these challenges is that many CAs have , overtly or tacitly , applied the July 2019 guidance retrospectively . In the worst cases , companies that have already been waiting for their authorisation decision for years may now be confronted with a rejection because the strict new guidance is applied . That may entail them having to restart the authorisation process , while no longer being able to benefit from the transitional provisions keeping their products on the market . In other words , products might temporarily have to be taken off market , not necessarily because of risk or efficacy concerns , but merely because of the very narrow way in which CAs interpret the BPF concept . However , it is not all doom and gloom . On the positive side , and hopefully increasingly so in the future , if the process is successfully completed , an authorised BPF provides fast and cheap marketability for new products ( to be added to the BPF ).
Legal aspects
Within all this uncertainty , the law can provide some stability . Firstly , now that the 2019 BPF guidance note is agreed , CAs should in principle apply that guidance . The note states that CAs should apply it to applications submitted from 1 October 2019 and only retrospectively if the applicant agrees . Do the authorities have to follow the guidance ? Although it is a wellestablished principle of EU law that EU guidance may be binding upon the EU institutions , provided that the guidance contains directions on the approach to be followed by the EU institutions and do not depart from the rules in the EU Treaties , CAs are not EU institutions and the July 2019 guidance comes with a clear disclaimer that they are not obliged to follow it .
“ Despite the laudable intention and efforts , the BPF rollout was beset by inherent problems from the beginning ”
However , it is trite law that EU MSs must nonetheless exercise their competence in accordance with EU law and not thus render the application impossible or excessively difficult . Furthermore , the principle of patere legem quam ipse fecisti ( Latin for ‘ Obey the law that you have yourself made ’) can be found in the national legal framework of several MSs . This again infers that MSs should stick to the guidance . Can a company challenge the July 2019 guidance or its retrospective application ? Is guidance normally challengeable ? Industry could variously refer to the legal principles of non-retroactivity , legal certainty and legitimate expectations when appropriate . They should also prevent the misuse of guidance and the retrospective application of guidance . On the latter point , as can be seen in the minutes from the CA July 2019 meeting , not all the MSs appear to agree only to apply the guidance to new dossiers .
Regardless of the above legal principles , things can still turn out badly . If that happens , it may be wise for a company or their technical consultant to first pick up the phone to the relevant CA . Asking for or providing clarification , or proposing a pragmatic way forward , can often help to resolve matters . If that does not work , it may be wise to get legal advice promptly . Any action against a rejected authorisation could be brought before the respective national administrative body , national court , or the EU ’ s General Court in Luxembourg ; it all depends on the type of BPF application ( national or Union ) and the stage of the evaluation .
Conclusion
In sum , while an authorised BPF has many advantages , the concept is still suffering from some ongoing complications since its introduction in 2012 . It has been narrowed since 2012 : by the BPR itself in 2014 , by CA guidance documents and by the limits of practical implementation . If you find yourself blindsided by a surprise rejection decision , or frustrated by the process of a BPF evaluation , you can always consult your lawyer to understand the lay of the land and to assist ( behind the scenes ) with your CA discussions . Legal action is always possible , but any problems should ideally be resolved before getting to that stage . •
Gerard McElwee
PARTNER IN EU REGULATORY LAW
FIELDFISHER - BRUSSELS k + 32 2 742 70 00 J gerard . mcelwee @ fieldfisher . com j www . fieldfisher . com
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