Critical SoHO supply sufficiency
1. Member States shall, within their territories and in collaboration with SoHO national authorities, SoHO competent authorities and SoHO entities, each within their respective competence, consider all reasonable efforts for achieving a sufficient, adequate and resilient supply of critical SoHO with a view to appropriately meet recipients’ needs, and to contribute to European self-sufficiency.
2. Member States shall make all reasonable efforts to:
(a)
facilitate public participation in SoHO donation activities for critical SoHO, with a view to ensuring a broad SoHO donor-base and SoHO donor-base resilience built on the standards concerning voluntary and unpaid donation in accordance with Article 54;
(b)
ensure that SoHO donor recruitment and retention strategies are put in place for critical SoHO, including communication campaigns and education programmes;
(c)
carry out the activities as referred to in paragraph 1 of this Article through preparedness and response measures, with due regard to Article 54; and
(d)
ensure optimal use of critical SoHO, taking into account therapeutic alternatives.
Accordingly, Member States shall encourage the collection of SoHO with a strong public and non-profit sector involvement.
3. Critical SoHO entities shall establish appropriate mechanisms for the continuous monitoring of their stocks of critical SoHO and shall be able, in the event of shortages or upon request, to communicate such information to their SoHO competent authorities.
SoHO competent authorities shall, in turn, establish appropriate mechanisms to receive such information referred to in the first subparagraph and shall be able to get an overview of the availability of critical SoHO in their territories, when needed.
4. In cases where the availability of critical SoHO depends on commercial interests, each Member State shall seek that the critical SoHO entities, within the limit of their responsibilities, provide an appropriate and continuous supply of critical SoHO for recipients in their territory.
National SoHO emergency plans
1. Member States, in collaboration with SoHO national authorities, shall draw up national SoHO emergency plans setting out measures to be applied without undue delay when the demand or the supply situation for critical SoHO presents, or is likely to present, a serious risk to human health.
2. In developing national SoHO emergency plans, Member States shall ensure cooperation and consultation, as appropriate, with their health surveillance bodies, military medical services, civil protection services and other services routinely involved in emergency responses. Member States shall implement national SoHO emergency plans in coordination with other response actions at national or Union level, if adopted, and, where relevant, in a manner consistent with the national prevention, preparedness and response plans developed in accordance with Article 6 of Regulation (EU) 2022/2371 and with Directive (EU) 2022/2557 of the European Parliament and of the Council ( 20 ) .
3. Member States shall draw up the plans referred to in paragraph 1 of this Article, setting out the following elements:
(a)
potential risks to the supply of critical SoHO;
(b)
the designation of critical SoHO entities and any other relevant third party to be involved in the supply of critical SoHO;
(c)
a consolidated national overview of critical SoHO entity emergency plans referred to in Article 67;
(d)
the powers and responsibilities of SoHO competent authorities in situations of emergency as referred to in paragraph 1 of this Article;
(e)
procedures for sharing information, where appropriate, via the EU SoHO Platform, as well as elements of information to be exchanged with the SoHO national authorities of the other Member States and with other parties concerned, as appropriate, including in cases of shortages of critical SoHO with cross-border impact;
(f)
preparedness and response measures for specific identified risks, in particular those concerning communicable disease outbreaks, war or terrorist attacks and environmental disasters;
(g)
a procedure for the assessment and authorisation, in the context of a health emergency situation and in accordance with Article 65, of requests from SoHO entities for derogations from the obligation to have a SoHO preparation authorisation pursuant to Article 38(1);
(h)
a mechanism to ensure that in a health emergency situation, critical SoHO are prioritised according to specific medical needs.
4. Member States shall take into account the guidance of the ECDC, for emergencies related to epidemiological outbreaks, and the guidelines published by the EDQM, for emergency planning in general.
5. Member States shall involve relevant stakeholders in the elaboration of their national SoHO emergency plans, in particular by cooperating with their critical SoHO entities, as well as with the EDQM and the ECDC. Member States shall review at least every 4 years such plans in order to take into account changes in the designation of critical SoHO entities, the organisation of SoHO competent authorities and the experience gained from implementing the plans and simulation exercises.
6. Member States shall present a summary of their national SoHO emergency plans, and major reviews of those plans, within the SCB.
7. The SCB, in cooperation with the Commission, shall support a coordinated approach to ensure the implementation of the national SoHO emergency plans in cases where an emergency affects more than one Member States or in the case of emergencies with an effect beyond the Union, to communicate and collaborate with relevant international organisations and authorities.
Supply alerts for critical SoHO
1. Critical SoHO entities shall, without undue delay, send a SoHO supply alert to their SoHO competent authorities in the event of significant shortages of supply of critical SoHO, indicating the underlying reasons, the expected impact on recipients and any mitigating actions taken, including in relation to possible alternative supply channels if appropriate.
Shortages shall be considered significant when:
(a)
the human application of critical SoHO or the distribution of critical SoHO for the manufacture of products regulated by other Union legislation, as referred to in Article 2(6), is cancelled or postponed, or there is a significant risk of being cancelled or postponed, due to unavailability; and
(b)
the situation referred to in point (a) poses a serious risk to human health.
2. SoHO competent authorities that receive a SoHO supply alert referred to in paragraph 1 of this Article shall:
(a)
communicate that SoHO supply alert to their SoHO national authority;
(b)
implement appropriate measures to mitigate the risks, to the extent possible; and
(c)
take into account the information received in accordance with paragraph 1 of this Article in the review of the national SoHO emergency plans referred to in Article 63.
3. The SoHO national authorities shall submit, without undue delay, to the EU SoHO Platform the SoHO supply alert received in cases where the supply interruption might affect other Member States and may do so where such interruption might be addressed through cooperation, including through exchange of SoHO, between Member States as referred to in Article 63(3), point (e).
Derogation from the obligations to authorise SoHO preparations in health emergency situations
1. By way of derogation from Article 19, SoHO competent authorities may permit, at the request of a SoHO entity as referred to in Article 38(3) and duly justified by a health emergency situation, the distribution, or preparation for immediate human application, of SoHO preparations within their territory even if the procedures referred to in Article 19 have not been carried out, provided that:
(a)
the human application of those SoHO preparations is in the interest of public health;
(b)
the SoHO preparations have a level of quality and safety that is acceptable considering the requirements of this Regulation or the available data indicate a positive benefit-risk assessment; and
(c)
the SoHO preparation is for immediate human application to a defined group of SoHO recipients, who have no therapeutic alternative, the treatment cannot be postponed, the prognosis is life-threatening and the expected benefit outweighs the risks.
The intended SoHO recipients or, where applicable, persons granting consent on their behalf, shall be informed of the derogation and shall give their consent to the immediate human application of that SoHO preparation, in accordance with national legislation, prior to the human application itself.
2. SoHO competent authorities shall:
(a)
indicate the period of time for which the permission referred to in paragraph 1 is granted and if such SoHO preparations may be distributed to other Member States;
(b)
instruct the requesting SoHO entity to submit an application for a SoHO preparation authorisation pursuant to Article 39 and collect retrospectively data on the human application of the SoHO preparation during the health emergency situation;
(c)
inform the SoHO national authority of the permission referred to in paragraph 1, provided for the SoHO preparation concerned.
3. The SoHO national authority shall inform the Commission and the other Member States via the EU SoHO Platform of any decision to permit the distribution, or preparation for immediate human application, of SoHO preparations in accordance with paragraph 1.
4. In cases where such SoHO preparations might be distributed to other Member States, the SoHO national authority of the receiving Member State shall confirm the validity of the permission within its territory before the distribution takes place.
Emergency derogations in man-made or natural disasters
1. Insofar as necessary to ensure supply of critical SoHO, Member States may allow for derogations from certain standards and obligations set out in this Regulation when large scale life-threatening situations in the context of man-made or natural disasters, in particular in the context of armed conflicts, pose a risk to human life, and such derogations are the only measure available to mitigate the risk. Derogations shall not be granted from the provisions of this Regulation that concern voluntary and unpaid donation and SoHO donor consent. The derogations shall be applied in a manner that ensures the protection of SoHO donors and SoHO recipients to the maximum extent possible in the circumstances of the crisis.
2. Member States granting such derogations shall inform the other Member States and the Commission without undue delay and provide reasons for the measures taken.
SoHO entity emergency plans
Each critical SoHO entity shall draw up a SoHO entity emergency plan that implements the national SoHO emergency plan as referred to in Article 63.
Member States may consider that the measures set out in this Chapter are at least equivalent to the obligations laid down in Directive (EU) 2022/2557.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
