QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| The Queen (on the application of Zagorski and Baze)
|- v -
|Secretary of State for Business, Innovation
Archimedes Pharma UK Ltd
WordWave International Limited
A Merrill Communications Company
165 Fleet Street, London EC4A 2DY
Tel No: 020 7404 1400, Fax No: 020 7404 1424
Official Shorthand Writers to the Court)
Mr. Martin Chamberlain and Ms. Victoria Wakefield (instructed by the Treasury Solicitor) for the Defendant
Ms. Kelyn Bacon (instructed by Arnold & Porter (UK) LLP) for the Interested Party
Hearing dates: 17th and 22nd November 2010
Crown Copyright ©
The Hon. Mr. Justice Lloyd Jones:
The history of the proceedings.
"It follows that, as things stand, I have no power to prevent individual shipments of Sodium Thiopental. I have considered in the light of your letter whether I should exercise my power under the Export Control Act 2002 to make an Order controlling the export of Sodium Thiopental, whether to the United States or generally. The effect of such an order would be to require any exporter of Sodium Thiopental to seek a licence where the conditions of the Order apply. However, I have reached the conclusion that this would not be justified.
My reasoning for this is as follows. Sodium Thiopental is a medicine. Its primary use is as an anaesthetic. Indeed it appears on the World Health Organisation's Model List of Essential Medicines. It follows from this that legitimate trade of medical value would be affected by any restriction on the export of this product from the UK. Furthermore, I have considered the fact that an export restriction imposed by the United Kingdom is very unlikely to be effective in preventing any execution from taking place in the United States, given that the drug is generally available and traded globally."
"The application to vacate the order by the district court granting a temporary restraining order, presented to Justice Kennedy and by him referred to the Court is granted. There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe. The district court granted the restraining order because it is left to speculate as to the risk of harm. See order granting Motion for a Temporary Restraining Order in Landrigan v Brewer, No. CV/10/02246/PHX/ROS (D Ariz.), Doc. 21, p. 15 ("[T]he Court is left to speculate…whether the non-FDA approved drug would cause pain and suffering"). But speculation cannot substitute for evidence that the use of the drug is "sure or very likely to cause serious illness and needless suffering". Baze v Rees, 553 US 35, 50 (2008) (quoting Helling v McKillney 509 US 25, 33 (1993)). There was no showing that the drug was unlawfully obtained, nor was there an offer of proof to that effect."
"Archimedes Pharma holds a marketing authorisation for Sodium Thiopental, an anaesthetic licensed in the UK for general anaesthesia and other indications. The Company supplies the product in the UK, in accordance with regulations, through the recognised pharmaceutical supply chain, primarily to wholesalers and hospital pharmacies. Consistent with applicable regulations the Company does not have information on specific end purchases or users of its products. The Company neither exports the product to the US for any purpose nor is it aware of any exports of the product."
(1) Archimedes does not itself manufacture Sodium Thiopental. Rather it is the marketing authorisation holder for Sodium Thiopental in the United Kingdom. The product itself is manufactured on behalf of Archimedes in Austria by Sandoz, a division of Novartis.
(2) Sodium Thiopental is an anaesthetic listed on the World Health Organisation Model List of Essential Medicines. It is indicated in the United Kingdom for use in particular in status epilepticus, a life-threatening condition where the patient suffers repeated epileptic fits in a short period of time. Archimedes understands it is used regularly in the United Kingdom for this purpose.
(3) In the United States, Sodium Thiopental was until recently manufactured by Hospira. The package insert for Hospira's version of the product lists uses very similar to the uses indicated in the United Kingdom.
(4) Archimedes does not itself sell or export to the United States and has no knowledge of any exports to the United States by United Kingdom customers that have purchased the product (directly or indirectly) from Archimedes. Archimedes' main customer in the United Kingdom is a major pharmaceutical distributor who sells the product to third parties who are mainly NHS customers, but also includes some secondary wholesalers. Archimedes is able to trace its product to the customers of its major distributor, but once the product is in the hands of a secondary wholesaler Archimedes is not able to trace where and for what purpose the product is subsequently sold by that wholesaler.
(5) Archimedes has a very small direct export business in Sodium Thiopental.
(6) In relation to the reports relating to the source of the Sodium Thiopental used in a recent execution in Arizona, the lot and batch numbers of the product have not been reported. For that reason, together with Archimedes' lack of knowledge generally as to the final destination of the product when sold to a secondary wholesaler, Archimedes is not able to confirm whether it was indeed the ultimate source of the Sodium Thiopental that was used in Arizona.
(1) The fact that it now appeared that the State of Tennessee had obtained enough Sodium Thiopental to execute the First Claimant.
(2) The intention of Leigh Day to apply to join the Second Claimant.
(3) The evidence as to the shortage of Sodium Thiopental in the United States and the possibility that the State of Kentucky may try to obtain the drug in the United Kingdom.
(4) The evidence lodged as to the extent of the clinical use of Sodium Thiopental in the United States.
(5) The fact that Archimedes took a neutral stance on the claim and would not contest the relief sought by the Claimant.
(1) One way in which, in principle, export controls could be imposed on Sodium Thiopental would be to add the drug to the list of goods subject to export control either generally or in relation to the United States in particular. This would have the effect that whenever a person in the United Kingdom wished to export it (or export it to the United States) he would have to apply for and obtain a licence before doing so. However, this process would give rise to difficulties.
(a) This would impose a serious regulatory burden on those seeking to export the drug (or export it to the United States) for legitimate medical purposes.
(b) Imposing an export control order in relation to Sodium Thiopental would set a precedent and it would be necessary to consider imposing similar controls in relation to a range of other medicines which might be used in executions.
(2) An alternative form of export control would be "end-use" control. This operates by reference not to specific goods but to any goods exported which the exporter knows or suspects may be used for a particular purpose. It would be open to the Secretary of State to stipulate in relation to a particular end-use control whether actual knowledge or mere suspicion would be sufficient to trigger the application of the control.
(3) The United Kingdom supports the introduction of an end-use control for torture equipment at the European level as a concerted EU initiative, as this is more likely to be effective. Even at the EU level the United Kingdom's position is that such a control would only be appropriate if it were triggered by actual knowledge by an exporter that the goods were likely to be used for the purposes of torture or other inhuman and degrading treatment. There would be few cases in which the exporter would have such knowledge on its own. In most cases, it would be put on notice by the UK authorities notifying it (on the basis of intelligence or other information) that a particular shipment was intended for a particular proscribed end-use. The United Kingdom would not support an end-use control based on suspicion because it would run the risk of generating licence applications from responsible exporters in respect of large numbers of goods in circumstances which do not really generate concern. As such it would be unduly burdensome.
(4) A unilateral end-use control in relation to goods which could be used for the purposes of capital punishment would be undesirable for two reasons
(a) A unilateral export control would be likely to be ineffective because it would not stop exports from other parts of the EU to third countries such as the United States.
(b) A knowledge-based end-use control would not be effective to achieve the First Claimant's aim. In particular, it would not prevent the export of a medicine to a US wholesaler, either directly or indirectly, unless the exporter was put on notice of the intended end use. The circumstances of the present case suggest that it would be difficult to say, in respect of any particular shipment, that it was intended for any particular end-use. If, on the other hand, the control were framed so as to apply whenever the exporter knew or suspected that the goods would be used for execution, a responsible exporter might consider itself obliged routinely to refer export orders for a variety of goods including medically useful products which could be used for capital punishment.
(5) "Against these disadvantages, you may consider that the advantage of imposing an export control – either on sodium thiopental or on goods whose end-use is for capital punishment – is slight. You should assume that it is possible (though far from certain) that the imposition of such a control might delay one or more executions. Even in that case, it is unlikely that any delay attributable to your decision would be for more than a few months. It remains very unlikely that the decision to impose a unilateral export control would prevent any execution from taking place given that the UK is by no means the only source of the drug."
The statutory powers of the Defendant.
"5. General restriction on control powers.
(1) Subject to Section 6, the power to impose export controls, … may only be exercised where authorised by this section.
(2) Controls of any kind may be imposed for the purpose of giving effect to any Community provision or other international obligation of the United Kingdom.
(3) In subsection (2) "international obligation" includes an obligation relating to a joint action or common position adopted, or a decision taken, by the Council under Title V of the Treaty on European Union (provisions on a common foreign and security policy).
(4) Export control may be imposed in relation to any description of goods within one or more of the categories specified in the Schedule for such controls.
"6. Exceptions from the general restriction.
(1) Section 5 does not apply to the power to impose any controls if the control order which imposes them provides for its expiry no later then the end of the period of twelve months beginning with the day on which it is made."
"D The carrying out anywhere in the world of (or of acts which facilitate)
(d) Breaches of human rights."
EU law on export controls.
"The exportation of products from the European Community to third countries shall be free, that is to say, they shall not be subject to any quantitative restriction, with the exception of those restrictions which are applied in conformity with the provisions of this regulation."
"Without prejudice to any other Community provisions, this Regulation shall not preclude the adoption or application by a Member State of quantitative restrictions on exports on grounds of public morality, public policy or public security; the protection of health and life of humans, animals and plants; the protection of national treasures possessing artistic, historic or archaeological value, or the protection of industrial and commercial property."
"(3) Article (2) of the Charter of Fundamental Rights of the European Union states that no one shall be condemned to the death penalty or executed…
a. Article 4 of the Charter states that no one shall be subjected to torture or to inhuman or degrading treatment or punishment.
[The "Guidelines to the EU policy toward third countries, on torture and other cruel, inhuman or degrading treatment or punishment"] also provide for third countries to be urged to prevent the use and production of, and trade in, equipment which is designed to inflict torture or other cruel, inhuman or degrading treatment or punishment and prevent the abuse of any other equipment to these ends. They also make the point that the prohibition of cruel, inhuman or degrading punishment imposes clear limits on the use of the death penalty. Therefore and in line with these texts, capital punishment is not to be considered a lawful penalty under any circumstances.
(7) It is therefore appropriate to lay down Community rules on trade with third countries in goods which could be used for the purpose of capital punishment and in goods which could be used for the purpose of torture and other cruel, inhuman or degrading treatment or punishment. These rules are instrumental in promoting respect for human life and fundamental human rights and thus serve the purpose of protecting public morals. Such rules should ensure that Community economic operators do not derive any benefits from trade which either promotes or otherwise facilitates the implementation of policies on capital punishment or on torture and other cruel, inhuman or degrading treatment or punishment, which are not compatible with the relevant EU Guidelines, the Charter of Fundamental Rights of the European Union and international conventions and treaties.
(10) It is also necessary to impose controls on exports of certain goods which could be used not only for the purpose of torture and other cruel, inhuman or degrading treatment or punishment, but also for legitimate purposes. These controls should apply to goods that are primarily used for law enforcement purposes and, unless such controls prove disproportionate, to any other equipment or product that could be abused for the purpose of torture and other cruel, inhuman or degrading treatment or punishment, taking into account its design and technical features."
"1. Any export of goods which have no practical use other than for the purpose of capital punishment or for the purpose of torture and other cruel, inhuman or degrading treatment or punishment, listed in that Annex II, shall be prohibited, irrespective of the origin of such equipment."
The items listed in Annex II do not include Sodium Thiopental. Indeed the Annex states that it does not cover medical-technical goods. No drugs are included in Annex II.
"(1) For any export of goods that could be used for the purpose of torture and other cruel, inhuman or degrading treatment or punishment, listed in Annex III, an authorisation shall be required, irrespective of the origin of such goods…"
Sodium Thiopental is not included in the list of goods in Annex III. The only chemical substances included are two substances for the purpose of riot control or self protection.
The relevance of the Torture Regulation and the Export Control Order 2008.
The grounds of challenge.
(1) is a breach of Article 4, Charter of Fundamental Rights of the European Union;
(2) is a breach of the common law protection of fundamental rights and the principle of legality; and
(3) is contrary to the purposes of the Export Control Act 2002 and on the material before the Defendant was irrational.
The applicability of the European Convention on Human Rights.
"The High Contracting Parties shall secure to everyone within their jurisdiction the rights and freedoms defined in section 1 of this Convention."
"59. As to the "ordinary meaning" at the relevant term in Article 1 of the Convention, the Court is satisfied that, from the standpoint of public international law, the jurisdictional competence of a State is primarily territorial. While international law does not exclude a State's exercise of jurisdiction extra-territorially, the suggested bases of such jurisdiction (including nationality, flag, diplomatic and consular relations, effect, protection, passive personality and universality) are, as a general rule, defined and limited by the sovereign territorial rights of the other relevant States…
60. Accordingly, for example, a State's competence to exercise jurisdiction over its own nationals abroad is subordinate to that State's and other States' territorial competence… In addition, a State may not actually exercise jurisdiction on the territory of another without the latter's consent, invitation or acquiescence, unless the former is an occupying State in which case it can be found to exercise jurisdiction in that territory, at least in certain respects…
61. The Court is of the view, therefore, that Article 1 of the Convention must be considered to reflect this ordinary and essentially territorial notion of jurisdiction, other bases of jurisdiction being exceptional and requiring special justification in the particular circumstances of each case…"
"68. Reference has been made in the Court's case law, as an example of jurisdiction "not restricted to the national territory" of the respondent State…, to situations where the extradition or expulsion of a person by a Contracting State may give rise to an issue under Articles 2 and/or 3 (or, exceptionally, under Articles 5 and/or 6) and hence engage the responsibility of that State under the Convention…
However, the Court notes that liability is incurred in such cases by an action of the respondent State concerning a person while he or she is on its territory, clearly within its jurisdiction, and that such cases do not concern the actual exercise of a State's competence or jurisdiction abroad (see also, the above-cited Al-Adsani judgment, at para 39)."
(See also Al-Saadoon v. United Kingdom (2010) 51 EHRR 9 at paragraphs 123-4.)
Ground 1: the failure of the Defendant to act to prevent the export of sodium thiopental to the United States when there is strong reason to believe that it will be used for the purposes of executing the Claimants is a breach of Art. 4, Charter of Fundamental Rights of the European Union.
Right to Life.
2. Everyone has the right to life.
3. No one shall be condemned to the death penalty, or executed.
Prohibition of torture and inhuman or degrading treatment or punishment.
No one shall be subjected to torture or to inhuman or degrading treatment or punishment."
Article 2 corresponds to Article 2 ECHR. Article 4 corresponds to Article 3 ECHR.
Field of application
"1. The provisions of this Charter are addressed to the institutions, bodies, offices and agencies of the Union with due regard for the principle of subsidiarity and to Member States only when they are implementing Union law. They shall therefore respect the rights, observe the principles and promote the application thereof in accordance with their respective powers and respecting the limits of the powers of the Union as conferred on it in the Treaty.
2. The Charter does not extend the field of application of Union law beyond the powers of the Union or establish any new power or task for the Union, or modify powers and tasks as defined in the Treaties."
Scope and interpretation of rights and principles
2. Rights recognised by this Charter for which provision is made in the Treaty shall be exercised under the conditions and within the limits defined by those Treaties.
3. In so far as the Charter contains rights which correspond to rights guaranteed by the Convention for the Protection of Human Rights and Fundamental Freedoms, the meaning and scope of those rights shall be the same as those laid down by the said Convention. This provision shall not prevent Union law providing more extensive protection.
4. In so far as this Charter recognises fundamental rights as they result from the constitutional traditions common to the Member States, those rights shall be interpreted in harmony with those traditions.
1. Field of application.
(1) It is correct that the Charter does not include a provision corresponding to Article 1 of the Convention. Indeed, there is no provision of the Charter which, to employ the terminology of the Court of Justice (see, for example, Case C-85/96 Martinez Sala v Freistaat Bayern at paragraphs 57, 61), directly addresses the scope ratione personae of the rights recognised by the Charter. Article 51 is not concerned with the scope of application of the Charter in this sense. Rather it is concerned with the scope of it application ratione materiae. It makes clear, in conformity with the principle of subsidiarity to which it expressly refers, that the provisions of the Charter are addressed to Member States only when they are implementing EU law, the issue addressed earlier in this judgment. Article 51 (1) of the Charter cannot therefore further the Claimants' argument as to the scope ratione personae of the Charter.
(2) The preamble to the Charter states that it is to be interpreted with due regard to the explanations prepared under the authority of the Praesidium of the Convention which drafted the Charter. The Explanations relating to the Charter of Fundamental Rights (2007/C 303/02) state in relation to Article 51:"As regards Member States, it follows unambiguously from the case-law of the Court of Justice that the requirement to respect fundamental rights defined in the context of the Union is only binding on the Member States when they act in the scope of Union law…"That passage and the cases cited there (Case 5/88 Wachauf  ECR 2609; Case C-260/89 ERT  ECR I-2925; Case C-309/96 Annibaldi  ECR I-7493) make clear that what is addressed in Article 51 is field of application in the sense of scope ratione materiae.
(3) However, Article 52(3) has a vital bearing on the scope ratione personae of the rights recognised by the Charter. This provides that in so far as the Charter contains rights that correspond to Convention rights "the meaning and scope of those rights shall be the same as those laid down by the said Convention". To my mind this refers not merely to the content of the rights but also to the scope of their application ratione personae. That is the natural meaning of the words. It also accords with the Preamble to the Charter which states that it "reaffirms … the rights as they result, in particular, from the constitutional traditions of the Member States, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the Social Charters adopted by the Union and by the Council of Europe and the case law of the Court of Justice of the European Union and of the European Court of Human Rights". Furthermore, the purpose of the provision is to ensure that these Charter rights shall have the same effect as the Convention rights to which they correspond, save – as the last sentence of Article 52 (3) indicates – to the extent that EU law may provide for more extensive protection. In the absence of such an extension, each Charter right is intended to be co-extensive with its corresponding Convention right. (In the same way paragraphs (2) and (4) of Article 52 are intended to ensure that rights recognised in the Charter which are provided for in the Treaties or resulting from common constitutional traditions of Member States respectively, correspond to the rights from which they are derived.) This necessarily includes not only the content of the rights but also the scope of their application in the sense of the persons on whom the rights are conferred.
(4) The Explanations relating to the Charter of Fundamental Rights confirm this reading."Paragraph 3 is intended to ensure the necessary consistency between the Charter and the ECHR by establishing the rule that, in so far as the rights in the present Charter also correspond to rights guaranteed by the ECHR, the meaning and scope of those rights, including authorised limitations, are the same as those laid down by the ECHR…The reference to the ECHR covers both the Convention and the Protocols to it. The meaning and the scope of the guaranteed rights are determined not only by the text of those instruments, but also by the case-law of the European Court of Human Rights and by the Court of Justice of the European Union. The last sentence of the paragraph is designed to allow the Union to guarantee more extensive protection. In any event, the level of protection afforded by the Charter may never be lower than that guaranteed by the ECHR."
(5) If the Claimants were correct in their submission that the Charter recognises Convention Rights without the limitation imposed by Article 1 ECHR, the result would be very radical indeed. Whereas States party to the Convention undertake to secure Convention rights to persons within their jurisdiction (in the sense explained in Bankovic) the Charter would confer such rights on anyone, anywhere in the world, regardless of whether they have any connection with the EU. That such a result should be brought about without any express reference to the massive extension which was being effected would be most surprising.
(6) The Explanations relating to the Charter of Fundamental Rights identify the Articles of the Charter where both the meaning and the scope are the same as the corresponding Articles of the ECHR. They state that Article 2 corresponds to Article 2 ECHR and Article 4 corresponds to Article 3 ECHR. I conclude therefore that the intention is that these provisions of the Charter are intended to have the same effect as the corresponding provisions of the Convention.
"WHEREAS the Charter reaffirms the rights, freedoms and principles recognised in the Union and makes those rights more visible, but does not create new rights or principles;…"
and provides in Article 1(1):
"The Charter does not extend the ability of the Court of Justice of the European Union, or any court or tribunal of Poland or of the United Kingdom, to find that the laws, regulations or administrative provisions, practices or action of Poland or of the United Kingdom are inconsistent with the fundamental rights, freedoms and principles that it reaffirms."
Ground 2: The failure of the Defendant to act to prevent the export of Sodium Thiopental to the United States when there is strong reason to believe that it will be used for the purposes of executing the Claimants is a breach of the common law protection of fundamental rights and the principle of legality.
"In the absence of express language or necessary implication to the contrary, the courts therefore presume that even the most general words were intended to be subject to the basic rights of the individual."
However, the difficulty with this argument, to my mind, is that the circumstances of the present case do not provide any scope for the operation of a presumption of interpretation operating as a constitutional principle that, in the absence of express language or necessary implication to the contrary, a result which infringes fundamental rights cannot have been intended.
Ground 3: The failure of the Defendant to act to prevent the export of Sodium Thiopental to the United States when there is strong reason to believe that it will be used for the purposes of executing the Claimants is contrary to the purposes of the Export Control Act 2002 and on the material before the Defendant was irrational.