Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear.  Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators.  To address this, the Commission’s proposal introduces a new classification mechanism that aims to clarify early in the development process whether a product is potentially a medicine. 

EMA will be able to give scientific recommendations on the regulatory status of products under development

The draft Regulation introduces a new “borderline” mechanism which allows a developer or a national competent authority to request a scientific recommendation from the EMA on the regulatory status of a product under development.  Such a recommendation will only be available for products that may fall within the mandatory scope of the centralised procedure.  Upon a “duly justified request,” the EMA will determine whether a product in question is potentially a medicinal product, including an advanced therapy medicinal product (“ATMP”).

To ensure that the recommendations given by the EMA take into account other legal frameworks, the EMA should consult relevant advisory or regulatory bodies in related fields.  For products based on substances of human origin (“SoHO”), the proposal specifically identifies the SoHO Coordination Board, a new body that will be established by the SoHO Regulation.

But the European Commission will have the final ‘say’

If a Member State disagrees with a recommendation issued by the EMA, it will be able to request the Commission to decide whether the product is potentially a medicinal product, including an ATMP.  The Commission may also do so on its own initiative.  The Commission decision will be adopted by means of implementing acts, taking into account the scientific recommendations from the EMA.

The Commission will be able also to ask the EMA for clarifications or send the recommendation back to the Agency for further consideration.  According to the proposal, the Commission may do so where a “substantiated request” from a Member State raises new scientific or technical questions or on its own initiative.

Member States will need to ensure that there is communication between medicines and SoHO authorities

The draft Directive explicitly obligates Member States to ensure that when questions arise regarding the regulatory status of a medicinal product in relation to their link to SoHO, the national competent authorities consult the relevant SoHO authorities.

How do other frameworks deal with borderline cases?

Medical Devices — Under Article 4 of the Medical Device Regulation 2017/745, the Commission upon a “duly substantiated request” from a Member State or on its own initiative may decide, by means of implementing acts, whether a specific product (or a category or group of products) is a medical device or an accessory for a medical device.  In doing so the Commission consults the Medical Device Coordination Group (“MDCG”) that was established by the Medical Devices Regulation.  If a product at issue involves, for example, a medicinal product, the Commission should ensure “an appropriate level of consultation” with the EMA.

SoHO — The Commission proposal for a SoHO Regulation introduces an obligation on national competent authorities to consult authorities established in other relevant EU legislation (i.e., medical devices, medicines, food) in cases where questions arise as to the regulatory status of a substance, product or activity.  During the consultation, national competent authorities may request the SoHO Coordination Board (“SCB”) to give its opinion on the regulatory status.  They must do so, if they are not in the position to take a decision on the regulatory status themselves. When requesting the SCB for its opinion, national competent authorities may indicate whether there is a need to consult the equivalent advisory authorities. 

Upon a “duly substantiated request” from a Member State or on its own initiative, the Commission may decide, by means of implementing acts, on the regulatory status of a substance, product or activity under the SoHO Regulation, in particular when the questions on the regulatory status cannot be resolved at the national level or in discussions between the SBC and the advisory bodies established in other relevant EU legislation.

The possibility of a Classification Advisory Council or a joint EMA-SCB panel have been floated in the ENVI Committee

The Commission Proposal for the SoHO Regulation is currently in the hands of the ENVI Committee, which is busy with agreeing on compromise amendments.  Several amendments relating to borderline issues have been tabled (see here, here, here and here), including a proposal to establish a Classification Advisory Council.  It would include representatives of the SCB, the EMA and the MDCG.  The Classification Advisory Council would assist Member States and the Commission in determining the regulatory status of a substance, product or activity covered by the SoHO Regulation. Another amendment proposes to introduce a joint permanent EMA-SCB panel that would consult, when needed, the MDCG.

The proposed amendments reflect the need to have a unified approach in borderline classification cases. The proposal for the SoHO Regulation is still going through the legislative process, so it is not clear how the borderline issues will be tackled in the final text.  Since the proposal for the SoHO Regulation and the proposals for the revision of the pharmaceutical rules are linked, the debate over the SoHO Regulation proposal should be closely monitored to anticipate possible changes to the proposed mechanism for medicinal products.

This blog is based on the wording of the EU’s proposal published on 26 April 2023.  This wording could significantly change during the legislative process.  Our Dublin, Brussels, Frankfurt and London teams will continue to monitor this legislation. We will be hosting a webinar to discuss the impact on 9 May. To sign up for the webinar please click here.