Document No. No of Pages Description Decision Basis of Refusal 1 2 Index Release 2 2 Abortion ...

376 Pages·2011·2.12 MB·English

Schedule for FOI Briefing for Ministers Reilly and Fitzgerald
Document No. No of Pages Description Decision Basis of Refusal
1 2 Index Release
2 2 Abortion Release
3 2 Administration of Morning After Pill Release
4 2 Assisted Human Reproduction Release
5 3 Briefing Material Arrangements Release
6 52 Brief for Minister of Children Part Release Section 11(1)(b)
7 2 Business Plan Overviews: Primary Care Release
8 3 BPO: Acute Hospitals, Cancer Release
9 4 BPO: CMO Release
10 3 BPO: Finance Release
11 2 BPO: National HR Release
12 2 BPO: Office of Older People Release
13 3 BPO: Parliamentary and Corporate Affairs Release
14 3 Cancer Services Release
15 5 Chronic Diseases Release
16 20 Note on Department Release
17 5 Disability Release
18 5 Drugs Release
19 2 Early Childhood Care and Education Release
20 2 Female Genital Mutilation Release
21 3 Food Safety Release
22 24 Governance of HSE Part Release Sections 20(1), 21(1)(c), 27(1)(c)
23 2 Head Shops Misuse of Drugs Release
24 2 Health Behaviours Release
25 3 Health Protection Release
26 1 Health Research Part Release Section 20(1)(a)
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Schedule for FOI Briefing for Ministers Reilly and Fitzgerald
Document No. No of Pages Description Decision Basis of Refusal
27 2 Human Tissue and Organ donation Release
28 5 Medicines Release
29 5 Mental Health Release
30 1 Palliative Care Release
31 10 Patient Safety Part Release Section 27(1)(c)
32 24 Private Health Insurance Detailed Part Release Sections 20(1), 22(1)(a), 27(1)(b), 32(1)(a)
33 13 Public Health Release
34 1 Rare Diseases Release
35 28 Acute Hospitals Part Release Section 20(1)
36 16 Child Welfare and Protection Unit Part Release Section 11(1)(b)
37 7 Office for Older People Part Release Sections 20(1), 31(1)(b)
38 16 Primary Care Part Release Sections 20(1), 21(1)(b)
39 4 Social Inclusion Release
40 2 Sun bed Legislation Release
41 2 Tobacco Control Release
42 46 Enablers Part Release Sections 19(1)(a), 20(1), 21(1)(c), 22(1)(a), 27(1)(b)
43 15 Letter to Michael Scanlan from Sean McGrath Release
44 2 Blood Safety Release
45 17 Significant Issues document for MAC Part Release Sections 19(1)(a), 20(1), 22(1)(a), 31(1)(b), 46(1)(b)
46 3 Co Location Withheld Section 20(1)
47 2 National Plan for Oncology Withheld Sections 20, 27
48 3 Private Health Insurance Withheld Section 27
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ABORTION

Background

The European Court of Human Rights heard in December 2009 an application by
three women that it is a breach of their rights under the Council of Europe
Convention on Human Rights for the Irish State not to provide abortion in
circumstances where a woman wishes to undergo an abortion (the A, B and C case).
The object of the application was stated to be to demonstrate that the constitutional
and criminal law of the Irish State breaches the Applicants’ rights. The Government
submitted that the application be deemed inadmissible primarily on the basis that the
Applicants failed to exhaust their domestic remedies.

The judgement of the Court confirms that Article 40.3.3 of the Constitution is in
conformity with the European convention on Human Rights.

The Court held:
 In the case of the first and second applicants, Ms A and Ms B, the Court
dismissed their applications, finding that there had been no violation of their rights
under the Convention.
 In the case of the third applicant, Ms C, the Court found that Ireland had
failed to respect the applicant’s private life contrary to Article 8 of the Convention,
as there was no accessible and effective procedure to enable her to establish
whether she qualified for a lawful termination of pregnancy in accordance with
Irish law.

The Court ruled that "no criteria or procedures have been... laid down in Irish law...
by which that risk is to be measured or determined, leading to uncertainty…" and
held that further legal clarity was required. The Court acknowledged that the
implementation of Article 40.3.3 "would be a sensitive and complex task" and
confirmed that it was not for that Court to indicate the most appropriate means for
Ireland to achieve this.

The judgement of the European Court of Human Rights is binding on Ireland.
Supervision of Ireland’s execution of the judgment falls to the Committee of Ministers
of the Council of Europe. The Council of Europe have proposed that supervision of
the judgement in A, B and C v Ireland would be under a new enhanced procedure for
supervision of judgements rather than the standard procedure of simplified
supervision. Enhanced supervision concerns complex cases to which the Committee
of Ministers give priority and which would also entail more intensive involvement of
the Secretariat. Enhanced supervision will not add to our existing obligation to
implement the judgement.

Action Plan

Steps will need to be taken to ensure no future similar violations of Article 8 occur.
Ireland is required to submit an action plan to the Committee of Ministers within six
months of the judgement (in this case by the 16th of June 2011). The action plan
must set out the measures Ireland intends to take to implement the judgement.
Where it is not possible to identify all the measures immediately, the plan must set
out the steps to be taken to determine the measures required, including an indicative
timetable for such steps.
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The Social Inclusion Unit is currently preparing a paper on viable options for the
implementation of the judgement with the Department’s legal advisors. This paper will
then be submitted for managerial and Ministerial approval.

 This is one of two issues pertaining to the remit of the Social Inclusion Unit to
appear on the Risk Register, along with Assisted Human Reproduction (AHR). The
Unit is hoping to be able to prepare options for an Action Plan in relation to the ABC v
Ireland ruling as well as policy proposals for AHR. However, in light of current
resources, a decision will then have to be made as to which of these issues will be
prioritised for the development of regulations/legislation.

Social Inclusion Unit
24th February 2011
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Briefing Material for the Minister

Administration of Morning-After Pill by Pharmacists

Background
In January, 2011, Boots Ireland wrote to the former Minister advising of their
intention to offer a pharmacist-led Emergency Contraception Service to women over
18.

This involved the Boots medical director setting out in a formal protocol or “patient
group direction” the specific patient types, circumstances and procedures to be
followed by a Boots pharmacist in determining whether an emergency hormonal
contraceptive would be appropriate for the patient presenting at the pharmacy. The
protocol required the patient to be interviewed by a Boots pharmacist in the private
consultation area to determine whether it was appropriate for the patient to be
administered the product.

(By way of background, in July 2010, Minister Harney launched the Boots Ireland
Patient Group Direction Services and in particular its seasonal influenza vaccination
service which commenced in October 2010).

Patient Group Directions under Irish Medicines Legislation

The initiatives taken by Boots relied on Regulation 4A(1)(c) of the Medicinal
Products (Prescription and Control of Supply) Regulations 2003-2009. This provides
that it is not a contravention of the Regulations for any person to administer a
prescription medicine to a patient in accordance with the directions of a medical
practitioner.

During the Swine Flu Pandemic in Autumn/Winter 2009/2010 this provision was used
by the HSE to allow the administration by nurses and other health professionals at
HSE clinics of pandemic vaccines (which are prescription medicines) to patients in
accordance with the directions of a HSE medical officer, without the requirement for
that practitioner to assess every patient and write a prescription in each case.

Patient Group Directions have been used in the UK for some time and are used for
managing single treatment episodes rather than chronic illnesses.

Legal Advice in relation to Regulation 4A(1)(c)

Legal advice was sought by the Irish Medicines Board in regard to the emergency
hormonal contraception service provided by Boots. This opinion concluded that the
scheme operated by Boots did not comply with Regulation 4A(1)(c). Boots were so
advised and have suspended the Emergency Contraception Service launched in
January.

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The Department’s Legal Unit has been consulted and, in summary, it concurs with the
advice obtained by the IMB. In view of the potential implications of this advice for
patient group directions generally, further legal clarification is being been sought.

Current Position with regard to Emergency Hormonal Contraceptive Products

On 15th February, 2011 the Irish Medicines Board announced its decision to allow the
sale of NorLevo without prescription. It is one of two emergency contraception pills
currently licensed for use in Ireland. It may now be supplied from pharmacies
without a prescription.

On 17th February the Pharmaceutical Society of Ireland issued guidelines to
pharmacists under the Pharmacy Act 2007 requiring that the emergency hormonal
contraceptive may only be supplied by the pharmacist personally and following a
private consultation between the patient and pharmacist. This is to ensure that the
pharmacist can determine the appropriateness of the supply and to provide an
opportunity to undertake appropriate patient counselling.

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ASSISTED HUMAN REPRODUCTION

Current Work on Legislation

The Department of Health and Children is currently developing policy proposals to
regulate the area of Assisted Human Reproduction. Patients are currently availing of
these services in a legal vacuum, as there is no specific legislation in Ireland
governing AHR. As indicated in the Supreme Court ruling in the frozen embryos
case (see overleaf) and by the Attorney General following the same, legislation is
urgently required in order to regulate this area appropriately.

The legislative framework must protect, promote and ensure the health and safety of
parents, donors and children born as a result of assisted reproductive technologies.
The legislation will outline what practises are prohibited, what practices are allowed
and how they should be regulated. The work involved in developing these proposals
will examine and consider - among other things - the issues arising from the frozen
embryos Supreme Court judgment.

Current Position

The handling, processing, storage, etc, of human tissue, including gametes and
embryos, is currently regulated under the European Communities (Quality and Safety
of Human Tissues and Cells) Regulations (Statutory Instrument No.158 of 2006)
came into law on 7 April, 2006. The Regulations apply to tissues establishments that
are involved in the donation, procurement, testing, processing, preservation, storage
and distribution of human tissues and cells intended for human applications. The aim
of the Regulations is to ensure a high level of protection of human health. The
Regulations include criteria for assessing the status of prospective donors, inspection
and control measures, traceability of donations and qualifications and training for
persons working in tissue establishments.

Fertility clinics are tissue establishments under the Regulations and thus, they must
be inspected and authorised by the Irish Medicines Board (IMB), which is the
competent authority under the Regulations, to ensure that they meet quality and
safety standards.

The Medical Council include specific guidance in the area of AHR in the ethical
guidelines issued periodically to registered medical practitioners for application in the
clinical situations in which they work. Section B (20.1-20.4) of the 7th Edition of the
Medical Council Guidelines provide as follows:

20.1 Assisted human reproduction treatments, such as In Vitro Fertilisation
(IVF), should only be used after thorough investigation has shown that no
other treatment is likely to be effective. You should ensure that appropriate
counselling has been offered to the patient and that the patient has given
informed consent before receiving any treatment.

20.2 Assisted reproduction services should only be provided by suitably
qualified professionals, in appropriate facilities, and according to
international best practice. Regular clinical audit and follow-up of outcomes
should be the norm.

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20.3 If you offer donor programmes to patients, you must consider the
biological difficulties involved and pay particular attention to the source of
the donated material. Such donations should be altruistic and non-
commercial. You should keep accurate records for future reference.

20.4 You should not participate in creating new forms of life solely for
experimental purposes. You should not engage in human reproductive
cloning.

Frozen Embryo Case

The background to the frozen embryos case is that the Plaintiff (wife) sought an order
from the High Court to have three frozen embryos stored in an Irish fertility clinic
released to her against the wishes of her estranged husband. The woman argued that
the embryos had a right to life under Article 40.3.3 of the Constitution. The High Court
found that such frozen embryos did not constitute the unborn for the purposes of
40.3.3. The Plaintiff then appealed against the High Court judgment and the Supreme
Court decided last December that the frozen embryos at issue in the case did not have
the constitutional protection of Article 40.3.3 of the Constitution.

In effect, the appeal of Mrs. R from the High Court was dismissed by all five judges
and the Court was unanimous in deciding that the frozen embryos did not enjoy the
protection of Article 40.3.3 of the Constitution. The judges agreed that, on an analysis
of the text of the Constitution, the language describes a foetus which is adversely
affecting the right to life of the mother. This can only arise in the situation where they
are in a physical relationship with each other, in other words, where the embryo has
implanted in the uterine wall and there is a pregnancy.

Mr. Justice Geoghegan acknowledged that it is not an easy task to provide guidance
on these matters. Indeed the Commission on Assisted Human Reproduction itself
recognized that using technology to assist human reproduction raises important ethical
issues for our society.

 This is one of two issues pertaining to the remit of the Social Inclusion Unit to
appear on the Risk Register, along with Abortion. The Unit is hoping to be able to
prepare policy proposals for AHR as well as options for an Action Plan in relation to
the ABC v Ireland ruling on abortion. However, in light of current resources, a
decision will then have to be made as to which of these issues will be prioritised for
the development of regulation/legislation.

Social Inclusion Unit
18th February 2011
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Briefing arrangements

Minister

1. I attach a set of briefing papers which have prepared on a thematic basis as
follows:

(1) Primary care including primary care teams, GPs, pharmacy, medical
cards, community drug schemes and oral/dental health;

(2) Acute hospitals including activity/capacity, reconfiguration, EDs, waiting
times for elective surgery, ambulance/patient transport, maternity, the national
paediatric hospital, the Lourdes Hospital redress scheme, symphysiotomy, the
Drogheda review, cystic fibrosis and co-location;

(3) Cancer including cancer services and the national plan for radiation
oncology;

(4) Social care including services for children, disability, mental health and
older people, and other work of the Office of the Minister for Children &
Youth Affairs, the Office for Disability & Mental Health, and the Office for
Older People;

(5) Public health including health protection, health promotion, chronic
disease management, social exclusion, food, medicines, head shops, dugs and
tobacco control;

(6) Patient safety/quality including the Madden Commission, licensing and
other legislative proposals, HIQA, professional regulation, the Patient Safety
First initiative, the national framework for clinical effectiveness, healthcare
associated infections, blood safety and organs/tissue issues;

(7) Governance including HSE accountability arrangements, estimates and
expenditure management, capital funding, employment control, pensions and
the Department’s direct funded agencies;

(8) Private health insurance;

(9) Enablers including Croke Park, clinical programmes, information, ICT,
research and workforce planning;

(10) The Department including its mandate, staffing, administrative budget,
legislative programme, parliamentary work and international work; and

(11) Other topics including assisted human reproduction, abortion, female
genital mutilation, the early childhood care and education scheme, other
childcare schemes, palliative care, rare diseases.
2. I am also attaching the following documents:

(a) a copy of Health in Ireland Key Trends 2010;

(b) an organisation chart for the Department;

(c) a summary of each Division’s business plan for this year;

(d) a copy of the HSE’s National Service Plan for 2011;

(e) a copy of the Public Service (Croke Park) Agreement 2010 – 2014;

(f) the latest sectoral plan for the health service; and

(g) a copy of the latest “Significant Issues” (a document which is prepared
each month for the MAC).

3. I propose, if you agree, to arrange a series of early meetings with each member
of the MAC (management advisory committee) so you can meet their senior
management teams and they can provide you with more detailed briefing on their
work areas. Indeed, I think a regular schedule of such meetings – at least twice a year
– is a useful/necessary way of allowing you to update yourself in a pro-active and
structured way on developments in the Department.

4. The MAC meets every week – generally on a Monday morning. We have a
separate “Min/MAC” meeting every two months attended by the Minister, Ministers
of State and the MAC.

5. I recommend you also have an early meeting with the HSE chairman and
CEO. You may also want to have an initial meeting with the HSE senior management
team. You are likely to have regular contact with the chairman/CEO (and individual
members of the senior management team) but I think you would find it useful to
continue a previous practice of regular (every two months) scheduled meetings
between yourself, myself and the chairman and CEO.

6. Heretofore, there was a similar arrangement (meeting every two months) with
the chairman and CEO of HIQA which you might also like to maintain.

7. As you know, the Government generally meets on a Tuesday morning when
the Dáil is in session and a Wednesday morning when the Dáil is in recess. I think it
would be useful to keep a regular slot in your diary for us to meet briefly (30 minutes
or so) on either Monday evening or early Tuesday morning ahead of the weekly
cabinet meeting.

8. From time to time, I meet the CEOs of the agencies under the Department’s
remit as a group to discuss issues of mutual interest. You might like to attend the next
such meeting which will take place around the end of March.

Michael Scanlan