Documents considered by the Committee on 25 November 2009, including the following recommendations for debate: Security of gas supply Mutual legal assistance in criminal matters between the EU and Japan - European Scrutiny Committee Contents


5  PREVENTION FROM SHARP INJURIES IN THE HOSPITAL AND HEALTHCARE SECTOR

(31086)
15305/09
COM(09) 577
Draft Council Directive implementing the Framework Agreement on prevention
from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM
and EPSU


Legal base Article 139(2)EC; QMV
Document originated26 October 2009
Deposited in Parliament 5 November 2009
DepartmentWork and Pensions
Basis of consideration EM of 16 November 2009
Previous Committee Report None
To be discussed in Council No date set
Committee's assessmentPolitically and legally important
Committee's decisionNot cleared; further information requested

Background

5.1 According to the Commission, injuries caused by needles and other sharp instruments (such as scalpels) are one of the most common[10] and serious risks to healthcare workers in Europe, and represent a high cost for health systems and society in general: and it adds that the workers in certain departments and activities, notably emergencies, intensive care, and surgical operations, are particularly at risk, with potentially serious consequences in relation to such blood-borne diseases as viral hepatitis and AIDS, and that, even if an infection is not confirmed in the majority of cases, those affected suffer considerable stress and anxiety, and usually have to take antiretroviral drugs with unpleasant side-effects.

5.2 It points out that, although existing Community legislation[11] lays down general preventive principles and measures, the European Parliament called upon it in July 2006 to submit an appropriate legislative proposal, amending Directive 2000/54/EC on biological agents at work. It says that, before doing so, it embarked — as required under Article 138(2) of the Treaty — on a consultation with management and labour (the European social partners[12] in the hospital and healthcare sector, recognised by the Commission in 2006) on the possible direction and content of such a measure, asking them also if they intended to negotiate a framework agreement. It notes that the workers' organisations favoured more specific legislation to reinforce protection, whereas the employers were opposed to any such initiative. However, it says that HOSPEEM and EPSU signed an Agreement in July 2009 establishing minimum provisions for the prevention of sharp injuries, and that, in accordance with Article 139(2) of the Treaty, they had subsequently requested it to put this forward for a Council Decision to underpin its application within the Community. The Commission adds that, in the context of Article 139, the term "Council Decision" can be interpreted as referring to either a directive, regulation or decision, and that it has decided that a Council Directive would be the most appropriate approach to pursue.

The current proposal

5.3 The draft of such a Directive is set out in this document, and its effect would be to make the Agreement between the social partners legally binding across the Community, and to provide both for its transposition into Member States' law and for penalties. However, the Council cannot amend a proposal of this kind, and can only accept or reject it.

5.4 The Agreement itself is annexed to the proposal, with the stated aim of achieving the safest possible working environment, and provides for an integrated approach to risk assessment and prevention, training, information and awareness-raising and monitoring. In particular, it would:

  • apply to all workers in the sector;
  • establish certain basic principles, including the role of a well-trained, adequately resourced workforce, and the key need to prevent exposure; the role of health and safety representatives; the duty of employers and the responsibilities of individual workers; the participation of workers in the development of policy and practice; the need for collaboration between employers and workers representatives; and the need for reporting to focus on systemic factors rather than individual mistakes;
  • set out risk assessment procedures, including the hazardous situations to be covered, and the factors to be taken into account in eliminating exposure and considering alternative systems.
  • address the measures needed to eliminate the risk of injuries, reduce the risk of exposure, and the protection to be afforded where effectives vaccines exist.

The Government's view

5.5 In his Explanatory Memorandum of 16 November 2009, the Parliamentary Under-Secretary of State at the Department for Work and Pensions (Lord McKenzie of Luton) says that the proposed Directive gives an option of implementation through national legislation or through social partners agreement, and that the Government will explore both approaches to see which is most suitable.

5.6 He notes that the scope is limited to the hospital and healthcare sectors, and "directly related services/activities", and is supported by key stakeholders, representing employers and employees, and by pressure groups,[13] whose membership is drawn from a range of organisations representing health care workers, individual clinicians, and manufacturers of the safer needles technology (including the Association of British Healthcare Industries). He adds that many of the measures are already covered by existing health and safety legislation, as well as by healthcare specific legislation, codes of practice and guidelines. (For example, employers are already required to ensure that exposure to biological agents including blood-borne viruses, is prevented or adequately controlled, and that staff receive sufficient training and instruction, and where appropriate vaccination, whilst National Institute for Clinical Excellence (NICE) guidelines state that "needle safety devices must be used where there are clear indications that they will provide a safer system of working for healthcare professionals".) Also, the Health and Social Care Act 2008 (Registration Requirements) Regulations 2009 and supporting codes of practice require that staff be protected from infection through the implementation of a range of procedures, many of which are covered by the proposed Directive.

5.7 The Minister points out that similar legislation has already been introduced in the United States, requiring all hospitals and healthcare facilities to introduce needle protective devices, although he notes that research in the UK shows that these alone will not reduce the numbers of injuries, unless combined with training on universal precautions, handling and disposal of sharps, and effective reporting systems. He says that all these are included in the proposed Directive, and are supported by NHS employers and public sector unions.

5.8 The Minister says that, although the Commission is not required to do an Impact Assessment on proposals to implement social partner agreements, the Government carried out a preliminary Impact Assessment in 2008 on draft proposals to amend the Biological Agents Directive to prevent the risk of sharp injuries to workers, and that this showed that these would be effectively cost-neutral, with the benefits from a reduction in injuries balancing out the additional costs involved in implementing procedures and additional training for staff. He adds that the Government is currently in the process of updating that Assessment, and will provide this as soon as it is ready. However, the Department of Health estimates that the costs to the NHS and others, such as social care, should be minimal because much of the proposed Directive is simply requiring compliance with existing good practice.

Conclusion

5.9 This strikes us as a useful initiative, but we have considerable doubt whether it is consistent with the provisions of the EC Treaty to use a Directive to implement it. Our concerns mirror those raised in our Report of 19 November on the draft Directive implementing the revised Framework Agreement on parental leave,[14] which we ask the Minister to consider.

5.10 Despite what the Commission says in its explanatory memorandum, neither Article 249 nor any other provision of the EC Treaty gives it discretion to set aside the express requirement of Article 139(2) that agreements between the social partners are to be implemented either by a collective agreement or by "a Council decision on a proposal from the Commission". A Decision is mentioned because a Decision, not a Directive, is the means by which a separate agreement made at Community level is made binding on those to whom it is addressed.

5.11 In addition, Article 139(2) does not refer to the adoption of "measures", which would be expected if the choice of legal instrument was intended to be left open, as can be seen from other Articles under this Title of the EC Treaty. Nor does it refer to cooperation of any kind with the European Parliament, stating simply that the Council shall act by QMV and, by clear inference, alone. A reference to the role of the European Parliament would be expected under this Title of the EC Treaty if a Directive had been contemplated by Article 139(2) EC, as Article 137(2) EC and many other provisions under this Title attest. Indeed, Article 137(2) EC would be the correct legal base for a Directive on the prevention from sharp injuries in the hospital and healthcare sector. The Directive on "the protection of workers from risks related to exposure to biological agents at work"[15] is a clear precedent for this.

5.12 Our concern goes wider than the present proposal. Article 155 of the Treaty on the Functioning of the European Union (TFEU) re-enacts Article 139 EC word for word except for cross-references to Article 153 of the TFEU rather than to Article 137 EC. So it is important that the meaning of Article 155 TFEU be clarified.

5.13 We would be grateful to the Minister for a response to our concerns on the legal base before considering this proposal further. In the meantime, we will continue to hold the document under scrutiny.




10   Some studies suggest that each year there are about 1.2 million such injuries number in Europe. Back

11   Notably Council Directive 89/391/EEC, Council Directive 89/655/EEC, Council Directive 93/42/EEC and Directive 2000/54/EC. Back

12   The European Hospital and Healthcare Employers' Association (HOSPEEM) and the European Federation of Public Services Unions (EPSU). Back

13   Such as the Safer Needles Network. Back

14   HC 5-i (2009-10), chapter 5 (19 November 2009) Back

15   2000/54/EC Back


 
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