Annexes to COM(2022)338 - Standards of quality and safety for substances of human origin intended for human application - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)338 - Standards of quality and safety for substances of human origin intended for human application. |
|---|---|
| document | COM(2022)338  |
| date | June 13, 2024 |
In order to ensure the effectiveness, efficiency and economy of the Commission controls, the control strategy will be oriented towards a balance of ex-ante and ex-post checks and focus on three key stages of grant/contract implementation, in accordance with the Financial Regulation:
- selection of proposals/tenders that fit the policy objectives of the Regulation
- operational, monitoring and ex-ante controls that cover project implementation, public procurement, pre-financing, interim and final payments, management of guarantees
- ex-post controls at the beneficiaries/contractors’ sites will also be carried out on a sample of transactions. The selection of these transactions will combine a risk assessment and a random selection.
2.2.2.Information concerning the risks identified and the internal control system(s) set up to mitigate them
The implementation of the new Regulation on standards of safety and quality for SoHOs focuses on the attribution of public procurement contracts as well as a number of grants for specific activities and organisations.
The public procurement contracts will mainly be concluded in areas such as digitalisation, provision of consulting/expertise and training (to support uptake).
Grants will mainly be awarded for support activities to non-governmental organisations, respective competent authorities of the Member States, health and healthcare professional organisations, national agencies, etc. The period of execution of the subsidised projects and activities varies from one to three years mostly.
The main risks are the following:
• Risk of not fully achievening the objectives of the Regulation due to insufficient uptake or quality/delays in the implementation of the selected projects or contracts;
• Risk of inefficient or non-economic use of funds awarded, both for grants (complexity of funding rules) and for procurement (limited number of economic providers with the required specialist knowledge entailing insufficient possibilities to compare price offers in some sectors);
• Reputational risk for the Commission, if fraud or criminal activities are discovered; only partial assurance can be drawn from the third parties' internal control systems due to the rather large number of heterogeneous contractors and beneficiaries, each operating their own control system.
The Commission put in place internal procedures that aim at covering the risks identified above. The internal procedures are in full compliance with the Financial Regulation and include anti-fraud measures and cost-benefit considerations. Within this framework, the Commission continues to explore possibilities to enhance the management and to realise efficiency gains. Main features of the control framework are the following:
Controls before and during the implementation of the projects:
• An appropriate project management system will be put in place focusing on the contributions of projects and contracts to the policy objectives, ensuring a systematic involvement of all actors, establishing a regular project management reporting complemented by on-site-visits on a case by case basis, including risk reports to senior management, as well as maintaining appropriate budgetary flexibility.
• Model grant agreements and service contracts used are developed within the Commission. They provide for a number of control provisions such as audit certificates, financial guarantees, on-site audits as well as inspections by OLAF. The rules governing the eligibility of costs are being simplified, for example, by using unit costs, lump sums, contributions not linked to costs and other possibilities offered by the Financial Regulation. This will reduce the cost of controls and put the focus on checks and controls in high risk areas.
• All staff sign up to the code of good administrative behaviour. Staff who are involved in the selection procedure or in the management of the grant agreements/contracts (also) sign a declaration of absence of a conflict of interest. Staff is regularly trained and uses networks to exchange best practices.
• Technical implementation of a project is checked at regular intervals at the desk on the basis of technical progress reports of the contractors and beneficiaries; in addition contractors'/beneficiaries' meetings and on-site-visits are foreseen on a case by case basis.
Controls at the end of the project: Ex-post audits are performed on a sample of transactions to verify on-the-spot the eligibility of cost claims. The aim of these controls is to prevent, detect and correct material errors related to the legality and regularity of financial transactions. With a view to achieving a high control impact, the selection of beneficiaries to be audited foresees to combine a risk based selection with a random sampling, and to pay attention to operational aspects whenever possible during the on-site audit.
2.2.3.Estimation and justification of the cost-effectiveness of the controls (ratio of "control costs ÷ value of the related funds managed"), and assessment of the expected levels of risk of error (at payment & at closure)
The yearly costs of the suggested level of controls under the third Health programme 2014-2020 represented approximately 4 to 7% of the yearly budget of the operational expenditure. This is justified by the diversity of transactions to be controlled. Indeed, in the area of health, direct management involves the attribution of numerous contracts and grants for actions of very small to very large sizes, and the payment of numerous operating grants to non-governmental organisations. The risk related to these activities concerns the capacity of (especially) smaller organisations to effectively control expenditure.
The Commission considers that the average costs of controls is likely to be the same for the actions proposed under this Regulation.
Under the third Health Programme 2014-2020, on a 5 years basis, the error rate for the on-the-spot audits of grants under direct management was 1.8% while for procurement contracts it was below 1%. This level of error is considered acceptable, as it is under the materiality level of 2%.
The proposed actions will not affect the way the appropriations are currently managed. The existing control system proved to be able to prevent and/or to detect errors and/or irregularities, and in case of errors or irregularities, to correct them. It will be adapted to include the new actions and to ensure that residual error rates (after correction) remain below the threshold of 2%.
2.3.Measures to prevent fraud and irregularities
As for its activities in direct management, the Commission shall take appropriate measures ensuring that the financial interests of the European Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportional and deterrent penalties. To this effect, the Commission adopted an anti-fraud strategy, latest update of April 2019 (COM(2019) 196), covering notably the following preventive, detective and corrective measures:
The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and on-the-spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds. OLAF shall be authorised to carry out on-the-spot checks and inspections on economic operators concerned directly or indirectly by such funding.
The Commission also implements a series of measures such as:
- decisions, agreements and contracts resulting from the implementation of the Regulation will expressly entitle the Commission, including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and inspections and to recover amounts unduly paid and, where appropriate, impose administrative sanctions;
- during the evaluation phase of a call for proposals/tender, the applicants and tenderers are checked against the published exclusion criteria based on declarations and the Early Detection and Exclusion System (EDES);
- the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation ;
- regular training on issues related to fraud and irregularities is given to all staff involved in contract management as well as to auditors and controllers who verify the beneficiaries' declarations on the spot.
3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
3.1.Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
·Existing budget lines
In order of multiannual financial framework headings and budget lines.
| Heading of multiannual financial framework | Budget line | Type of expenditure | Contribution | |||
| Number | Diff./Non-diff. 37 | from EFTA countries 38 | from candidate countries 39 | from third countries | within the meaning of Article 21(2)(b) of the Financial Regulation | |
| 2b | 06 06 01 - EU4Health Programme | Diff. | YES | YES | YES | NO |
3.2.Estimated financial impact of the proposal on appropriations
3.2.1.Summary of estimated impact on operational appropriations
– The proposal/initiative does not require the use of operational appropriations
–X The proposal/initiative requires the use of operational appropriations, as explained below. Appropriations will be redeployed within the financial envelope allocated to the EU4Health programme in the MFF 2021-27.
EUR million (to three decimal places)
| Heading of multiannual financial framework | 2b |
| DG: SANTE | Year 2024 40 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | ||
| □ Operational appropriations | |||||||
| 06 06 01 - EU4Health Programme | Commitments | (1a) | 15.691 | 11.600 | 9.650 | 11.650 | 48.592 |
| Payments | (2a) | 7.846 | 13.646 | 10.625 | 16.475 | 48.592 | |
| Budget line | Commitments | (1b) | 15.691 | 11.600 | 9.650 | 11.650 | 48.592 |
| Payments | (2b) | 7.846 | 13.646 | 10.625 | 16.475 | 48.592 | |
| TOTAL appropriations for DG SANTE | Commitments | =1a+1b +3 | 15.691 | 11.600 | 9.650 | 11.650 | 48.592 |
| Payments | =2a+2b +3 | 7.846 | 13.646 | 10.625 | 16.475 | 48.592 |
□ TOTAL operational appropriations | Commitments | (4) | ||||||
| Payments | (5) | |||||||
| □ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes | (6) | |||||||
| TOTAL appropriations under HEADING 2b of the multiannual financial framework | Commitments | =4+ 6 | 15.691 | 11.600 | 9.650 | 11.650 | 48.592 | |
| Payments | =5+ 6 | 7.846 | 13.646 | 10.625 | 16.475 | 48.592 |
Heading of multiannual financial framework | 7 | ‘Administrative expenditure’ |
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes.
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | |||
| DG: SANTE | |||||||
| □ Human resources | 0.804 | 0.804 | 0.804 | 0.804 | 3.216 | ||
| □ Other administrative expenditure | 0.901 | 0.901 | 0.901 | 0.901 | 3.603 | ||
| TOTAL DG SANTE | Appropriations | 1.705 | 1.705 | 1.705 | 1.705 | 6.819 |
| TOTAL appropriations under HEADING 7 of the multiannual financial framework | (Total commitments = Total payments) | 1.705 | 1.705 | 1.705 | 1.705 | 6.819 |
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | |||
| TOTAL appropriations under HEADINGS 1 to 7 of the multiannual financial framework | Commitments | 17.396 | 13.305 | 11.355 | 13.355 | 55.411 | |
| Payments | 9.550 | 15.350 | 12.330 | 18.180 | 55.411 |
3.2.2.Estimated output funded with operational appropriations
Commitment appropriations in EUR million (to three decimal places)
| Indicate objectives and outputs | Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | |||||||||||||
| OUTPUTS | ||||||||||||||||||
| Type | Average cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | Total No | Total cost | |
| SPECIFIC OBJECTIVE No 1 Protect citizens | ||||||||||||||||||
| Number of technical standard updates | 0.400 | 1.962 | 2.141 | 2.141 | 6.644 | |||||||||||||
| Subtotal for specific objective No 1 | 0.400 | 1.962 | 2.141 | 2.141 | 6.644 | |||||||||||||
| SPECIFIC OBJECTIVE No 2 Optimise access | ||||||||||||||||||
| Numbers of donations, human applications, cross-border exchanges, imports and exports of critical BTC by Member state | 1.791 | 3.219 | 3.255 | 3.255 | 11.520 | |||||||||||||
| Subtotal for specific objective No 2 | 1.791 | 3.219 | 3.255 | 3.255 | 11.520 | |||||||||||||
| SPECIFIC OBJECTIVE No 3 . Foster innovation | ||||||||||||||||||
| The number of BTC processes authorised /shared and accepted at EU level | 13.500 | 6.419 | 4.254 | 6.254 | 30.427 | |||||||||||||
| Subtotal for specific objective No 3 | 13.500 | 6.419 | 4.254 | 6.254 | 30.427 | |||||||||||||
| TOTALS | 15.691 | 11.600 | 9.650 | 11.650 | 48.592 |
3.2.3.Summary of estimated impact on administrative appropriations
– The proposal/initiative does not require the use of appropriations of an administrative nature
–X The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
EUR million (to three decimal places)
| 2024 | 2025 | 2026 | 2027 and subsequent years | TOTAL |
| HEADING 7 of the multiannual financial framework | ||||||||
| Human resources | 0.804 | 0.804 | 0.804 | 0.804 | 3.216 | |||
| Other administrative expenditure | 0.901 | 0.901 | 0.901 | 0.901 | 3.603 | |||
| Subtotal HEADING 7 of the multiannual financial framework | 1.705 | 1.705 | 1.705 | 1.705 | 6.819 |
| Outside HEADING 7 of the multiannual financial framework | ||||||||
| Human resources | ||||||||
| Other expenditure of an administrative nature | ||||||||
| Subtotal outside HEADING 7 of the multiannual financial framework |
| TOTAL | 1.705 | 1.705 | 1.705 | 1.705 | 6.819 |
The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
3.2.3.1.Estimated requirements of human resources
– The proposal/initiative does not require the use of human resources.
–X The proposal/initiative requires the use of human resources, as explained below:
Estimate to be expressed in full time equivalent units
| 2024 | 2025 | 2026 | 2027 and subsequent years | Total | ||
| □ Establishment plan posts (officials and temporary staff) | ||||||
| 20 01 02 01 (Headquarters and Commission’s Representation Offices) | 4 | 4 | 4 | 4 | 4 | |
| 20 01 02 03 (Delegations) | ||||||
| 01 01 01 01 (Indirect research) | ||||||
| 01 01 01 11 (Direct research) | ||||||
| Other budget lines (specify) | ||||||
| □ External staff (in Full Time Equivalent unit: FTE) 41 | ||||||
| 20 02 01 (AC, END, INT from the ‘global envelope’) | 2 | 2 | 2 | 2 | 2 | |
| 20 02 03 (AC, AL, END, INT and JPD in the delegations) | ||||||
| XX 01 xx yy zz 42 | - at Headquarters | |||||
| - in Delegations | ||||||
| 01 01 01 02 (AC, END, INT - Indirect research) | ||||||
| 01 01 01 12 (AC, END, INT - Direct research) | ||||||
| Other budget lines (specify) | ||||||
| TOTAL | 6 | 6 | 6 | 6 | 6 |
06 is the policy area or budget title concerned.
The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Description of tasks to be carried out:
| Officials and temporary staff | AD for leading audits, central coordination and chairing of SoHO Coordination Board and sub-groups and AST for logistics and administrative tasks |
| External staff | SNEs with sector expertise |
3.2.4.Compatibility with the current multiannual financial framework
The proposal/initiative:
–X can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).
Appropriations will be redeployed within the financial envelope allocated to the EU4Health programme in the MFF 2021-27
– requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
– requires a revision of the MFF.
3.2.5.Third-party contributions
The proposal/initiative:
–X does not provide for co-financing by third parties
– provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | Total | |||
| Specify the co-financing body | ||||||||
| TOTAL appropriations co-financed |
3.3.Estimated impact on revenue
–X The proposal/initiative has no financial impact on revenue.
– The proposal/initiative has the following financial impact:
on own resources
on other revenue
please indicate, if the revenue is assigned to expenditure lines
EUR million (to three decimal places)
| Budget revenue line: | Appropriations available for the current financial year | Impact of the proposal/initiative | ||||||
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| Article …………. |
For assigned revenue, specify the budget expenditure line(s) affected.
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
(1) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
(2) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3) Evaluation of the Union legislation on blood, tissues and cells {SWD (2019) 376 final} https://ec.europa.eu/health/system/files/2019-10/swd_2019_376_en_0.pdf
(4) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
(5) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67), Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121), and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(6) Revision of the EU general pharmaceuticals legislation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12963-Revision-of-the-EU-general-pharmaceuticals-legislation_en .
(7) Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control. COM/2020/726 final.
(8) https://ec.europa.eu/health/system/files/2019-10/swd_2019_376_en_0.pdf .
(9) IIA: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12734-Blood-tissues-and-cells-for-medical-treatments-&-therapies-revised-EU-rules_en .
(10) This concerns establishments that only do procurement of haematopoietic stem cells, lab testing, import or distribution, and are currently authorised as standard tissue/blood establishment.
(11) Individual NAT test for West Nile Virus can be replaced by pooled NAT test, which is EUR 7 cheaper per tested donation. Applicable to around 300 000 blood donations per year in countries affected by West Nile Virus, saving estimated based on 2016 calculation by NHSBT (UK blood service), see table 1 of the Evaluation {SWD (2019) 376 final}, section 5.3.1.2, p. 59.
(12) Council of Europe Committee on Bioethics (DH-BIO) Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors , available at: https://rm.coe.int/guide-financial-gain/16807bfc9a .
(13) Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).
(14) OJ C , , p. .
(15) OJ C , , p. .
(16) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
(17) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(18) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
(19) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(20) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(21) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(22) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(23)
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
(24) Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial-gain/16807bfc9a .
(25) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
(26) Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
(27) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).
(28) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46).
(29) OJ L 123, 12.5.2016, p. 1.
(30) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(31) OJ C , , p. .
(32) Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1).
(33)
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(34) As referred to in Article 58(2)(a) or (b) of the Financial Regulation.
(35) Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).
(36) Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx
(37) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(38) EFTA: European Free Trade Association.
(39) Candidate countries and, where applicable, potential candidates from the Western Balkans.
(40) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(41) AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JPD= Junior Professionals in Delegations.
(42) Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).