Competent Authority Policy Statement - Genetically Modified Organisms

This policy statement relates to the EU Regulation 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19).

Below you will find a joint statement on EU Regulation 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19) from HSENI and DAERA.

Policy Statement

EU Regulation 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19):

1.  EU Regulation 2020/1043 came into force in July 2020. This Policy Statement is intended to help stakeholders in scope of the EU Regulation understand how it impacts on the obligations contained in the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015, which implements EU Directive 2009/41 - on the contained use of genetically modified micro-organisms

2,  This Policy Statement does not address areas outside the remit of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015, such as the Deliberate Release of Genetically Modified Organisms (GMOs)

Clinical Trials

3.  Article 2 of Regulation 2020/1043 states that:

All operations related to the conduct of clinical trials, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19, with the exception of the manufacturing of the investigational medicinal products, shall not require a prior environmental risk assessment or consent in accordance with Articles 6 to 11 of Directive 2001/18/EC or Articles 4 to 13 of Directive 2009/41/EC when these operations relate to the conduct of a clinical trial authorised in accordance with Directive 2001/20/EC.

4.  For the purposes of the GMO (Contained Use) Regulations (Northern Ireland) 2015, HSENI interprets Article 2 to mean the following:

(a)  All operations related to the conduct of a clinical trial on a human medicine containing or consisting of GMOs intended to treat or prevent COVID-19, with the exception of the manufacturing of the human medicine, shall be exempt from certain requirements of the GMO (Contained Use) Regulations (Northern Ireland) 2015, as long as the clinical trial has been authorised under the Medicines for Human Use (Clinical Trials) Regulations 2004.

5.  Annex 1 lists the requirements that a clinical trial authorised under the Medicines for Human Use (Clinical Trials) Regulations 2004 is exempt from. The Annex contains details of the specific GMO (Contained Use) Regulations 2015 that are exempted and the corresponding EU Directive 2009/41 requirements referred to in this EU Regulation.  Users affected by this EU Regulation will be able to use this table to determine what they are currently exempted from with regards to their work with genetically modified micro-organisms and the GMO (Contained Use) Regulations (Northern Ireland) 2015.

6.  Users affected by this exemption should be reminded that:

• (a) the Competent Authority expects the requirements of the GMO (Contained Use) Regulations (Northern Ireland) 2015 not listed in Annex 1 to continue to be followed.
• (b) broader health and safety and environmental requirements are still in place

Authorisation of Human Medicines

7.  Article 3 pertains to the disapplication of certain requirements of the GMO (Contained Use) Directive 2009/41 if the human medicine in question has the requisite authorisation in place to be used as a human medicine.

8.  As Regulation 3(2)(b)(i) of the GMO (Contained Use) Regulations (Northern Ireland) 2015 already exempts human medicines with the requisite authorisation in place, no further action is required by those with the requisite authorisations to deliver compliance with EU Regulation 2020/1043 with regards to the contained use of GMOs.

Period of time the EU Regulation will apply

9.  Article 4 of EU Regulation 2020/1043 states that the Regulation shall apply either:

• (a) as long as the World Health Organisation has declared COVID-19 to be a pandemic; or
• (b) as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19 in accordance with Article 12 of Decision No 1082/2013/EU of the European Parliament and of the Council applies

10,  The Northern Ireland Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 Competent Authority shall take steps to keep this situation under review, and are committed to keeping stakeholders appropriately informed.

Annex 1a

Regulatory Requirements of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 within scope of the exemptions referred to in Article 2(1) of the EU Regulation (Articles 4-13 of EU Directive 2009/41 - on the contained use of genetically modified micro-organisms):

Annex 1b

Regulatory Requirements of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 that are exempted as a consequence of Article 2(1) of EU Regulation 2020/1043.

There are certain requirements contained within the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 that rely upon the outputs of other regulatory requirements that have been exempted by Article 2(1) of EU Regulation 2020/1043, for example – risk assessments and notifications.

The following GMO (CU) regulations are therefore also exempted:

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