Neutral Citation No [2013] NIQB 101 | Ref: | TRE9009 |
Judgment: approved by the Court for handing down | Delivered: | 11/10/2013 |
(subject to editorial corrections)* |
TREACY J
Introduction
Background
Relief Sought
(i) An order of certiorari to quash the lifetime ban and/or the decision of the Minister of 22nd September 2011 whereby the lifetime ban was upheld;
(ii) A declaration that the lifetime ban is unlawful, ultra vires and of no force or effect;
(iii) A declaration that, as the competent authority for the purposes of Directive 2002/98/EC and designated by the Blood Safety and Quality Regulations 2005 ("the 2005 Regulations"), the Secretary of State for Health is responsible for the determination of the appropriate deferral periods in Northern Ireland and, accordingly, the maintenance (or otherwise) of the lifetime ban;
(iv) In the alternative, an order of mandamus requiring the Minister and the Department forthwith to lift the lifetime ban and align the blood donation policy in Northern Ireland with that employed in England, Scotland and Wales.
(i) That the ban/decision are Wednesbury unreasonable because:
(a) The maintenance of the current lifetime ban fails to give any or adequate weight to the latest expert medical and scientific evidence, including that set out by the Advisory Committee on the Safety of Blood, Tissues and Organs ('the Advisory Committee'), which recently reviewed the policy pertaining to the current lifetime ban and concluded that there was no additional risk attaching to a 12 month deferral period, as opposed to the previous lifetime ban;
(b) The maintenance of the current lifetime ban is unsupported by evidence. Indeed, the evidence suggests that a lesser deferral period would be safer, given that there is a lesser risk of non-compliance.
(c) The maintenance of the current lifetime ban is illogical having regard to the acknowledged fact that Northern Ireland, when required to, calls upon the blood supply of Great Britain where the lifetime ban has now been lifted.
(d) The maintenance of the current lifetime ban is further illogical in that an individual who has had and continues to have heterosexual relations with a vast number of partners remains freely eligible to donate blood, whilst a male individual who has had homosexual relations with only one partner is precluded from blood donation, which is irrational in that the risk of HIV infection is far greater in relation to the heterosexual individual in such circumstances.
(e) The maintenance of the current lifetime ban fails to give any or adequate regard to the common legal framework for blood safety throughout the United Kingdom, pursuant to the 2005 Regulations, which apply throughout the four jurisdictions, such that it is irrational that the policy should be applied inconsistently throughout the United Kingdom.
(ii) The Minister's decision and the lifetime ban are contrary to directly effective EU law and/or the general enforceable principles of EU law and/or the relevant transposing provisions of domestic law in that:
(a) Article 4.1 of the European Directive 2002/98/EC provides for designation of a competent authority to implement the requirements of the Directive as to blood safety. By regulation 2(1) of the 2005 Regulations, the competent authority with the responsibility for determining policy is the Secretary of State for Health in England. The Northern Ireland Minister has acted in a field in which, by virtue of the provisions of the Directive and the 2005 Regulations, he has no authority to act.
(b) The lifetime ban, and its maintenance, are contrary to the EU principles of non-discrimination and proportionality; and/or the EU principle of protection of fundamental human rights, including the right not to be discriminated against on grounds of sexual orientation, the said rights having effect as general principles of EU law by virtue of Article 6(3) of the Treaty of European Union.
(c) The lifetime ban, and its maintenance, is further contrary to Article 21 of the Charter of Fundamental Rights of the European Union, having effect by virtue of the Article 6(1) of the Treaty of European Union.
(iii) In the alternative, the Minister has misdirected himself as to his ability to set policy in this area for the reasons set out at paragraph (i)(a) above.
(iv) The Minister's decision was unlawful pursuant to section 28A(10) of the Northern Ireland Act 1998 (as amended) by virtue of his having failed to secure Executive approval for the decision, contrary to the requirements of the Ministerial Code and by section 20(3) and/or section 20(4) of the 1998 Act as (i) the decision was a controversial decision and/or (ii) the decision was in respect of a cross-cutting matter.
(v) The Minister's decision was taken without any or adequate consultation;
(vi) The Minister's decision is infected by apparent bias;
(vii) The Minister has failed to give appropriate reasons for his decision.
Relevant Reports
The Advisory Committee on the Safety of Blood, Tissues and Organs (the "Advisory Committee" or "SaBTO") – Donor Selection Criteria Review – April 2011 (the "Advisory Committee Report")
"…The Terms of Reference for the Steering Group… includes reviewing deferral criteria related to sexual behaviour which has the potential to put transfusion recipients at increased risk of TTIs [transfusion transmitted infections] and the appropriateness of existing deferral criteria in the light of technological advances, specifically:
1. The appropriateness of continuing lifetime exclusion of men who have had sex with men (MSM)…" [pp8 and 9]
Behavioural Risk | Duration | |
1 | Sex with a sex worker | 1 Year |
2 | Accepting money or drugs for sex | Permanent |
3 | Sex with an intra-venous drug user (IVDU) | At least 1 year after last sexual contact |
4 | Sex with anyone who may ever have had sex in parts of the world where HIV/AIDS is common | At least 1 year after last sexual contact |
5 | Sex with anyone infected with HIV, Hepatitis B or C | At least 1 year after last sexual contact |
6 | Females who have sex with a man who had sex with a man | At least 1 year after last sexual contact |
7 | Anyone who thinks they may be HIV positive | 1 Year |
8 | Men who have ever had oral or anal sex with a man (MSM) | Permanent |
"Since 1985, men who have ever had oral or anal sex with another man (MSM) have been permanently deferred from donating blood in the UK. Similarly, individuals who have ever accepted money or drugs in exchange for sex are permanently deferred from donating blood. In 2006, a review of the permanent deferral of MSM found that there were insufficient data regarding compliance to determine the impact of any changes. Recently, data has become available on the level of compliance with the current donor deferral criteria. These data, together with advances in the testing and processing of donated blood, changes in the epidemiology of sexually transmitted infections (STIs) and improved scientific knowledge have prompted a review of donor deferral on the basis of sexual behaviour…
The review noted that process improvements and automation have significantly reduced the chance of errors in blood testing such that the modelled risk of a HIV infectious donation being released into the blood supply is 1 per 4.4 million donations. The introduction of either a 12 month or a 5 year deferral would not significantly affect this figure if the number of non-compliant individuals remained unchanged. Under the current permanent deferral, it was shown that 11 % of MSM had donated blood since becoming ineligible, although the majority of non-compliers had not had a risk exposure (ie oral or anal sex with a man) within the 12 months prior to donation. Upon investigation, non-compliers were shown to be supportive of a change to a 12 month deferral…
In the UK population as a whole, where risk factors were reported for new diagnoses of blood borne viruses, heterosexual sex was the most commonly reported risk factor for both acute Hepatitis B infection (63%) and human immunodeficiency virus (54%) during 2009…" [emphasis added] [p7]
"...There have been a number of incremental improvements in the ability to detect infection in donors and reduce the potential for transfusion transmission. These improvements are the result of scientific and technological advances in donation testing, notably i) Reduction of the window period through the introduction of nucleic acid technology (NAT) testing; ii) Effective use of Information Technology to reduce the number of human errors in the testing laboratory environment and product release errors; iii) Introduction of automated sample handling and tracking systems to reduce testing errors; iv) increased information surrounding compliance with the current deferral…" [p8]
"There were 79 new diagnoses of HIV in Northern Ireland in 2010. The highest ever annual figure of 91 new diagnoses of HIV was recorded in 2008. Previously, there were around 60 new cases annually in Northern Ireland. The trend in the number of new HIV cases is increasing in Northern Ireland, the UK and Europe, although compared with the rest of the UK, Northern Ireland had the largest proportional increase – around 300% - of new HIV diagnoses between 2000 and 2009. HIV/AIDS prevalence remains lower in Northern Ireland."
21. Regarding the reduction of the risk of transfusion transmitted HIV, the Advisory Committee Report provides:
"The risk of transfusion transmitted HIV has been reduced by improved screening using 4th generation EIA assays that detect HIV antibody/antigen. In addition, early HIV infection can be detected by p24 antigen specific assays however these have lower sensitivity compared to HIV NAT testing of mini-pools which was introduced in the early 2000s. Individuals in the early stage of HIV infection (window infections) without detectable HIV antibody/antigen may transmit infection, however HIV NAT testing reduces the window period to nine days". [p19]
"Great improvements in donation testing have been implemented since the last review of blood donor selection in relation to sexual behaviour." [p40]
"…When HIV was first discovered in the 1980s it was predominantly associated with homosexual men and as no rapid test was available all MSM were excluded from donating blood. Concern has been expressed by some commentators that a new sexually-transmitted infection could emerge in a similar way and that any change to MSM deferrals should take this into account." [p22]
"In addition to these technological advances and quality control there have been significant social, cultural and legal changes since 2001, which need to be considered when reviewing blood donor selection. The Equality Act 2010 prohibits discrimination on grounds of sexual orientation, but includes a provision which permits blood donor deferral if the refusal is a reasonable judgement made on the basis of available data." [p8]
Briefing Paper provided to the Minister from the Health Protection Branch of the Department – 1 July 2011 (the "Briefing Paper")
"Timescale: Urgent – DH would like to make a UK agreed announcement before 19th July 2011.
…
Recommendation(s): That you consider SaBTO's recommendations and based on their advice agree to a UK-wide response in a change in policy from a lifetime to a 12 month deferral period for men who have sex with men."
"12. In the UK population in 2009, where risk factors were reported for new diagnoses of blood-borne viruses, heterosexual sex was the most commonly reported risk factor for both acute Hepatitis B infection (63%) and HIV (54%). The intravenous drug user population had the highest risk of Hepatitis C virus (> 90% of new diagnoses)." [para 12]
"…The key determining factor for permanent deferral on the basis of sexual activity is that it would include persons whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood. DH has received legal advice that there is no bar on the face of the legislation which would prevent those currently subject to a permanent deferral criteria – such as MSM – from being moved to a relevant temporary deferral group if their sexual behaviour is no longer considered to be high risk. This would permit the application of a 12 month deferral period for MSM." [para15]
Draft Official Report (Hansard) from meeting of the Committee for Health, Social Services and Public Safety (the "Health Committee") which took place on 26 October 2011 on the issue of the lifetime ban (the "Hansard Report")
"…The Advisory Committee on the Safety of Blood, Tissues and Organs … advises the four UK Health Ministers on how to ensure the safety of blood, cells, tissues and organs for transfusion and transplantation…". [p17]
"[The Minister] has said that blood will be taken from England, Scotland and Wales under the system that they will implement… There are higher incidences of HIV in England, Scotland and Wales than in Northern Ireland. Therefore, in order for the Minister's argument to be consistent with the lifetime ban on the grounds of safety, he would have to apply the ban to blood from England, Scotland and Wales as well. However, that is not the case." [p5]
"…424 people access HIV specialist care in Northern Ireland, less than half of whom are men who have sex with men; in England the figure is 1.23 people per thousand; in Scotland 0.59 people per thousand; and it is 0.40 per thousand in Wales. Taking those figures together, 1.12 people per thousand of the population in England, Scotland and Wales are in that category, in Northern Ireland, the figure is 0.24 per thousand. There is a much greater risk in England, Scotland and Wales, although, as the experts say, it is still insignificant, and the system that they have put in place is more than robust. The argument that the ban is on safety grounds does not stack up if you are going to take blood from England, Scotland and Wales. In theory, the system there will be much more unsafe." [p9]
"…The trend in the number of new HIV cases is increasing in Northern Ireland, the UK and Europe, although compared with the rest of the UK, Northern Ireland had the largest proportional increase – around 300% - of new HIV diagnoses between 2000 and 2009. HIV/AIDS prevalence remains lower in Northern Ireland." [p18]
"It is normally fewer than 100 units a year. So, last year, for example, I think that we received two lots of 40 units. Blood was provided at the time of the bus crash, because it was thought that there might have been considerably higher requirement as it transpired, this year we did not need additional blood. It happens primarily when a major incident takes place... However, there could be a major incident, in which case we would be very glad to receive blood from either the UK or the Republic of Ireland." [p34]
"The Chairperson: Do you request that such blood is not derived from the MSM community?
Mr Poots: No." [p34]
"The Chairperson: So whatever the risk is, it is safe enough. The very low risk is low enough.
Mr Poots: If you are looking at the relative risks involved, they are diminished greatly by the small amounts we receive." [p35]
"…I want to make it clear at the outset that I have not made the final decision on blood donation by men who have had sex with men and that I will consider carefully all the relevant issues…
My first duty today is to provide reassurance to the public, recipients of blood donations and, indeed, the Committee on the robustness of the arrangements to maintain the safety and integrity of the blood supply in Northern Ireland. Appropriate donor selection, including compliance with deferral criteria, and accurate donation testing form the twin pillars that ensure the safety of our blood supply. That is the most important point for me in relation to this issue. As Minister, I will consider all the relevant evidence. I must also take into account the issue of wider public confidence…
...
The Department of Health announced on Thursday 8 September that England, Scotland and Wales were changing their blood donations policy for MSM and that the change would be implemented at blood donation sessions on 7 November 2011. Until 7 November, the permanent exclusion will continue to apply. I have not made any decision to change that at this point.
As the Committee is aware, SaBTO has considered advice from its review group on the issue of donations from men who have sex with men. SaBTO concluded that there was no longer a reason to maintain the lifetime ban on donations from men who have had sex with men. The details are set out in the briefing note, which was sent to the Committee. I have asked my officials to clarify a number of important issues around the circumstances and context of Northern Ireland in relation to the procedure for decision-making. I also intend to seek further information from SaBTO on the relative risks arising from potential donations. Until that work is complete, I am not in a position to finalise my views on those issues and to consider what response to the analysis of the SaBTO review group would be most appropriate in all circumstances.
…
In conclusion, I am sure that the Committee will understand that, given the complexity of the issue, I have asked for further advice and will be seeking further meetings to inform my decision. I will take whatever time is necessary to consider all aspects before reaching a final decision…[pp17 - 19]
…
There was perhaps an urgency in the question about what we were doing. At this stage, we do not intend to change anything. We will take all advice on this matter. As I indicated, there are things that have come to light even since then that would lead us to ask further questions." [p24]
"So, there is a range of things that I have to do before reaching a conclusion. We have to ask SaBTO a series of questions. Those questions are not about MSM but about people in general who give blood. For example, currently, people who have had sex with a prostitute can give blood after a year, as can people who have had sex in Africa. We want to pose questions about those issues, because I have concerns about them…" [p22]
"…if the 12-month referral were introduced, the risk would be 0.228 per million donations. The current risk is 0.227 per million donations, so that would be a rise of 0.001 per million donations…" [emphasis added] [p24]
"…The paper goes on to state that, if there is enhanced compliance with having a 12-month ban instead of the lifetime ban, the risk could be reduced... If the lifetime ban were scrapped and a 12-month deferral put in place, it could actually reduce the risk of infection considerably – probably by one third – if the figures in your paper are anything to go by." [emphasis added][p25]
"Even the figures from the Department show that compliance rates would be much enhanced if we were to go down that route." [p8]
"There are a number of views on that, and we are looking at all the legal perspectives on it". [p21]
"…Am I right in thinking that you have the power to not just follow GB standards but to actually go for a higher level of public protection than that which exists in the rest of the United Kingdom? Do you have the power to do that?
Mr Poots: It is certainly something that I am investigating. I will be raising with SaBTO my concern about some of the other categories that are currently giving blood." [p32]
Position of the Northern Ireland Blood Transfusion Service
"no particular issues about this change…"
and it was
"well linked into the UK work…and will be ready to implement the change from the beginning of September [2011]."
Relevant material in relation to whether the Minister made a decision in September 2011
"…It is the responsibility of each Health Minister to consider the recommendations provided by advisory committees such as SaBTO, and take the final decision on the policy implications for their country.
Today… the Department of Health, London, is announcing that the lifetime blood donation ban is lifted for men who have had sex with men… The change of policy will apply in England, Scotland and Wales. In Northern Ireland the Minister for Health, Social Services and Public Safety is considering whether the lifetime deferral should be changed…"
"Following the Minister's decision to keep the ban on blood donation by men who have sex with men, attached is a revised answer to AQO 331/11-15." [emphasis added]
"At the Minister's briefing session for oral questions… the Minister advised that…he had decided to keep the lifetime ban on blood donations by men who have had sex with men…" [emphasis added]
"I take the view that the current position in Northern Ireland should not be altered.
The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) has confirmed that the risk of HIV infection would, although by a small margin, increase as a result of a relaxation in the present lifetime deferral.
Safety must be my primary concern and I want to ensure the maximum public confidence." [emphasis added]
"Absence of decision
The Minister has not made any decision to refuse to lift the lifetime ban on men who have had sex with men from giving blood. His answer to the Assembly question asked by Mr Kinahan MLA as to whether he would consider lifting the ban was, "I take the view that the current position in Northern Ireland should not be altered…" This is no more than an expression of current opinion and the Minister, in his appearance before the Committee for Health, Social Services and Public Safety ("the Committee") on 26 October 2011, said that he had not made a final decision on the issue. The Minister also said that he was awaiting further advice from the UK Government Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO") on the relative risks arising from potential donations and he continues to await further information on this to inform his decision. Given that no substantive decision has been taken on this matter, there is simply, pending the Minister's further consideration, a continuation of existing policy and any challenge now falls foul of the requirements in RSC Order 53 rule 4.
The Minister's position on this issue was also made clear in the letter issued on 8 September by the Deputy Chief Medical Officer to the NI Blood Transfusion Service…which states that "The official line to take is: The change of policy will apply in England, Scotland and Wales. In Northern Ireland the Minister of Health, Social Services and Public Safety is considering whether the lifetime deferral should be changed.""
Legal Context
The Treaty on the functioning of the European Union
"1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.
Union…"
4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:
(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures…"
Background to the relevant Directives
(i) European Directive 2002/98/EC of the Parliament and Council (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) (the "2002 Directive"); and
(ii) Commission Directive 2004/33/EC (implementing the 2002 Directive as regards certain technical requirements for blood and blood components) (the "2004 Directive").
The 2002 Directive
"Whereas
(1) The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order to prevent in particular the transmission of diseases.
(2) .... all precautionary measures during their collection, processing, distribution and use need to be taken making appropriate use of scientific progress in the detection and inactivation and elimination of transfusion transmissible pathogenic agents
(3) ... It is essential ... that whatever the intended purpose, Community provisions should ensure that blood and its components are of comparable quality and safety throughout the blood transfusion chain in all Member States, bearing in mind the freedom of movement of citizens within Community territory. The establishment of high standards of quality and safety, therefore, will help to reassure the public that human blood and blood components which are derived from donations in another member State nonetheless meet the same requirements as those in their own countries."
"(5) In order to ensure that there is an equivalent level of safety and quality of blood components, whatever their intended purpose, technical requirements for the collection and testing of all blood and blood components including starting materials for medicinal products should be established by this Directive."
"According to Article 152(5) of the Treaty, the provisions of this Directive cannot affect national provisions on the donations of blood. Article 152(4)(a) of the Treaty states that Member States cannot be prevented from maintaining or introducing more stringent protective measures as regards standards of quality and safety of blood and blood components."
"Blood and blood components used for therapeutic purposes or for use in medical devices should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation and that any risk of transmission of infectious diseases is minimised; each and every blood donation should be tested in accordance with rules which provide assurances that all necessary measures have been taken to safeguard the health of individuals who are the recipients of blood and blood components."
"This Directive lays down standards of quality and safety of human blood and of blood components, in order to ensure a high level of human health protection."
(e) 'blood establishment' shall mean any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion.
(j) 'Deferral' shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary.
"1. Member States shall designate the competent authority or authorities responsible for implementing the requirements of this Directive."
"2. This Directive shall not prevent a Member State from maintaining or introducing in its territory more stringent protective measures which comply with the provisions of the Treaty."
"3. The competent authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply." [emphasis added]
"1. Blood establishments shall ensure that there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation referred to in Article 29(d) are met…"
"…The following technical requirements and their adaptation to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2):
…
(d) requirements concerning the suitability of blood and plasma donors and the screening of donated blood including
— permanent deferral criteria and possible exemption thereto
— temporary deferral criteria…" [emphasis added]
The 2004 Directive
"Whereas
Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when for transfusion so as to ensure a high level of human health protection
...Directive 2002/98/EC calls for the establishment of specific technical requirements.
This Directive lays down those technical requirements which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood..., "
"Blood establishments shall ensure that donors of whole blood and blood components comply with the eligibility criteria set out in Annex III."
"Persons whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood."
"Persons whose behaviour or activity places them at risk of acquiring infectious diseases that may be transmitted by blood."
"Defer after cessation of risk behaviour for a period determined by the disease in question, and by the availability of appropriate tests."
"Under exceptional circumstances, individual donations from donors who do not comply with the following criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of Directive 2002/98/EC."
Blood Safety and Quality Regulations 2005 ("the 2005 Regulations")
"2.—(1) The Secretary of State is designated the competent authority for the purpose of the Directive…"
"7.—(1) A blood establishment shall—
…
(c) ensure that all testing and processes of the blood establishment which are referred to in Parts 2 to 5 of the Schedule are validated…"
"(d) apply eligibility criteria for all donors of blood and blood components in accordance with Part 3 of the Schedule…"
"(3) A blood establishment shall ensure that, in relation to the blood and blood components which it collects, processes, stores or distributes—
(a) each donation of blood and blood components (including blood and blood components which are imported into the European Community) is tested in conformity with—
(i) the basic testing requirements for whole blood and apheresis donations, specified in paragraph (7)…"
"(7) The basic testing requirements with which blood establishments must ensure compliance pursuant to paragraph (3)(a)(i) are—
(a) testing to establish ABO Group, except in respect of plasma intended only for fractionation;
(b) testing to establish Rh D Group, except in respect of plasma intended only for fractionation; and
(c) testing for the following infections of donors—
(i) Hepatitis B (HBs-Ag);
(ii) Hepatitis C (Anti-HCV);
(iii) HIV 1 and 2 (Anti-HIV 1 and 2)."
Northern Ireland Act 1998
"Technical standards and requirements in relation to products in pursuance of an obligation under Community law but not standards and requirements in relation to food, agricultural or horticultural produce, fish or fish products, seeds, animal feeding stuffs, fertilisers or pesticides." [emphasis added]
"(3) The Committee shall have the functions set out in paragraphs 19 and 20 of Strand One of the Belfast Agreement.
(4) The Committee shall also have the function of discussing and agreeing upon—
(a) significant or controversial matters that are clearly outside the scope of the agreed programme referred to in paragraph 20 of Strand One of that Agreement;
(b) significant or controversial matters that the First Minister and deputy First Minister acting jointly have determined to be matters that should be considered by the Executive Committee."
"(1) A Minister or Northern Ireland department has no power to make, confirm or approve any subordinate legislation, or to do any act, so far as the legislation or act—
(a) is incompatible with any of the Convention rights;
(b) is incompatible with Community law;
…"
"(10) Without prejudice to the operation of section 24, a Minister or junior Minister has no Ministerial authority to take any decision in contravention of a provision of the Ministerial Code made under subsection (5)."
Ministerial Code
"Any matter which:-
(i) cuts across the responsibilities of two or more Ministers;
...
(v) is significant or controversial and is clearly outside the scope of the agreed programme referred to in paragraph 20 of Strand One of the Agreement;
...
shall be brought to the attention of the Executive Committee by the responsible Minister to be considered by the Committee.
Regarding (i), Ministers should, in particular, note that:-
- the responsibilities of the First Minister and deputy First Minister include standards in public life, machinery of government (including the Ministerial Code), public appointments policy, EU issues, economic policy, human rights, and equality. Matters under consideration by Northern Ireland Ministers may often cut across these responsibilities..." [emphasis added]
EU Charter of Fundamental Rights (the "EU Charter")
"(1) Any discrimination based on any ground such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited."
Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community, signed at Lisbon, 13 December 2007 (the "Lisbon Treaty 2007")
"6(1) The Union recognises the rights, freedoms and principles set out in the Charter of Fundamental Rights of the European Union of 7 December 2000, as adapted at Strasbourg, on 12 December 2007, which shall have the same legal value as the Treaties…"
"1. Any limitation on the exercise of the rights and freedoms recognised by this Charter must be provided for by law and respect the essence of those rights and freedoms. Subject to the principle of proportionality, limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the Union or the need to protect the rights and freedoms of others."
Arguments
Applicant
Respondent
Notice Party
Discussion
Was a Decision Made?
Wednesbury Unreasonable/Irrationality
'UAPMP data from 2008 for previously undiagnosed HIV infections ... shows that the prevalence was higher in MSM (3.1%; 291/9473) compared with heterosexual attendees (0.35%; 322/92,694)'
(a) Continue to maintain the position that MSM donors, by virtue of their behaviour are in the high risk category. In this scenario no additional analysis of risks passed to the blood recipient is necessary as permanent deferral is mandated; or
(b) Accept the alternative analysis in which MSM donors are placed in the less risky category and based on that to assume a temporary deferral period in relation to such donors of at least 12 months.
Discrimination
The Minister's Competence under EU Law
Directions as to functions of special agency
4. (1) The Department may direct a special agency to exercise on its behalf such functions with respect to the administration of such health and social care as are specified in the directions.
(2) The Department may give directions to a special agency with respect to the exercise of any functions exercisable by virtue of paragraph (1).
The Competent Authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply.
Requirements concerning the suitability of blood and plasma donors and the screening of donated blood including
- Permanent deferral criteria and possible exemption thereto;
- Temporary deferral criteria.
Breach of the Ministerial Code etc
"28A Ministerial Code
(1) Without prejudice to the operation of section 24, a Minister or junior Minister shall act in accordance with the provisions of the Ministerial Code.
(5) The Ministerial Code must include provision for requiring ministers or junior ministers to bring to the attention of the Executive Committee any matter that ought by virtue of section 20(3) or (4) to be considered by the Committee.
(6) The Ministerial Code must include provision for a procedure to enable any Minister ... to ask the Executive Committee to determine whether any decision that he is proposing to take or has taken relates to a matter that ought by virtue of section 20(3) or (4) to be considered by the Committee.
(10) Without prejudice to the operation of section 24 a Minister... has no ministerial authority to take any decision in contravention of a provision of the Ministerial Code made under subsection 5."
Paragraph 2.4 of the Ministerial Code provides:
"Any matter which:-
(i) cuts across the responsibilities of two or more Ministers;
...
(v) is significant or controversial and is clearly outside the scope of the agreed programme referred to in paragraph 20 of Strand One of the Agreement;
...
shall be brought to the attention of the Executive Committee by the responsible Minister to be considered by the Committee.
Regarding (i), Ministers should, in particular, note that:-
- the responsibilities of the First Minister and deputy First Minister include standards in public life, machinery of government (including the Ministerial Code), public appointments policy, EU issues, economic policy, human rights, and equality. Matters under consideration by Northern Ireland Ministers may often cut across these responsibilities..." [emphasis added]
Conclusion
(i) as the competent authority for the purposes of Directive 2002/98/EC and designated by the Blood Safety and Quality Regulations 2005 the Secretary of State for Health is responsible for the determination of the appropriate deferral periods in Northern Ireland and whether to maintain or not the impugned lifetime ban. Accordingly the Minister was not empowered to give any directions in relation to the implementation or interpretation of the Directives;
(ii) Para 38 of Schedule 3 to the Northern Ireland Act 1998 provides that technical standards and requirements in relation to products in pursuance of an obligation under Community law are reserved matters. Under para (d) of Art 29 of the 2002 Directive deferral criteria are included as a technical requirement. By virtue of Section 24(1) of the 1998 Act the Minister has no power to act incompatibly with Community law;
(iii) the lifetime ban is both controversial (it has generated much publicity and public debate, and views on the issue are highly polarised) and cross-cutting (it is acknowledged in the SaBTO report that it touches on equality issues, it further deals with the implementation of EU Directives) and as such the Minister had no authority to act without bringing them to the attention of the Executive Committee which he failed to do. In doing so the Minister breached the Ministerial Code and by virtue of Section 28A(10) of the 1998 Act he had no legal authority to take a decision in breach of the Ministerial Code;
(iv) for the reasons set out at paras 126-140 above the decision of the Minister was irrational.
[153] Accordingly, the application for judicial review is allowed.