Proposed Negative Statutory Instruments under the European Union (Withdrawal) Act 2018
Instruments recommended for upgrade to the affirmative procedure
Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019
Date laid: 18 June 2019
Sifting period ends: 4 July 2019
1.The two instruments which these Regulations amend were considered by Sub-Committee B when they were laid by the Department for Health and Social Care (DHSC) as draft affirmative instruments.1 DHSC says that this proposed negative instrument is made to “correct drafting defects and omissions” in the original regulations. However, it makes substantive amendments, including inserting provisions to provide a mechanism for companies affected by proposed decisions of the licensing authority in relation to rare diseases medicines (orphan) and paediatric matters to have those decisions reviewed by the Commission on Human Medicines, and creating a transitional period relating to the pharmacovigilance system master file. These amendments are sufficient to indicate that the amending instruments should also be made using the affirmative procedure. As such, the Committee recommends that this proposed negative instrument should be upgraded to the affirmative resolution procedure.
Proposed negatives about which no recommendation to upgrade is made
Pesticides (Amendment) (EU Exit) Regulations 2019
2.The purpose of this proposed negative instrument, laid by the Department for Environment, Food and Rural Affairs (Defra), is to amend retained direct EU legislation which underpins the regulatory regimes for plant protection products and maximum residue levels, so that oversight can continue to operate effectively after the UK’s withdrawal from the EU. Defra explains that the technical amendments are needed following the change in the EU exit date to 31 October, as further new EU legislation has come into force during the Article 50 extension and due to a number of errors in earlier EU exit instruments. One of the proposed changes would revoke a provision which currently allows Member States to require the payment of fees or charges to recover the costs of any work they carry out when dealing with applications for the renewal of approvals for active substances used in pesticides. Asked about the impact of this proposal, Defra told us that the fee charging provision will be “redundant post-exit […] as the UK will no longer need permission in order to make provision for the charging of fees and charges” and that, with regard to potential costs arising from the renewal of active substance approvals, “the existing fee system which operates under the [Plant Protection Product (Fees and Charges) Regulations 2011 (SI 2011/2132)] will continue to operate without any practical impact.”
3.The Committee notes that, in practice, the proposed revocation of a fee charging provision does not appear to impact on the UK’s existing fee charging regime, which will continue to operate under separate domestic legislation. At the same time, the Committee is of the view that the revocation may be regarded as triggering the affirmative procedure under the broad provision of Schedule 7 paragraph1(2)(b) of the European Union (Withdrawal) Act 2018 (“the EUWA”), according to which a statutory instrument should be subject to the affirmative procedure if it “relates to a fee in respect of a function exercisable by a public authority” in the UK. While, in line with the Committee’s policy remit, we do not express a definitive view on what is essentially a legal issue, it is arguable that the effect of the proposed revocation of the fee charging provision is to trigger the requirement under the EUWA for the affirmative resolution procedure to apply.
- Aviation Safety (Amendment etc.) (EU Exit) (No.2) Regulations 2019
- European Grouping of Territorial Cooperation (EU Exit) Regulations 2019
- REACH etc. (Amendment etc.) (EU Exit) (No. 3) Regulations 2019
1 Secondary Legislation Scrutiny Committee (Sub-Committee B), 16th Report, Session 2017-19 (HL 286).