In 2016, EU institutions approved an amendment to the European “Tools of Torture” regulation (EC 1236/2005). This regulation aims to ensure European products are not exported for use in torture or capital punishment. Certain commercially manufactured medicines are covered by the regulation as they are sought by foreign prisons for use in lethal injection executions.

The Tools of Torture regulation creates a list-based export control system, under which exporters require a license from their national export authority to sell certain “dual use” products overseas. To obtain a license, exporters must demonstrate that they have taken necessary steps to ensure that the product will not end up being used to carry out human rights abuses.

In 2011 the European Commission made an emergency amendment to the regulation in order to restrict the export of particular medicines which were sought for use in lethal injections. At the same time, the Commission initiated a process to consider a more fulsome review of the regulation, with a mind to proposing further substantive amendments.

A central focus of this review was ensuring the export control regime for medicinal products reflected the unique characteristics of the global trade in medicines. To this end, the European Commission convened a “Group of Experts” to advise on the drafting of the regulation, which included the Lethal Injection Information Center’s Maya Foa, along with doctors and pharmaceutical company representatives.

In January 2014 the European Commission proposed its draft amendment to the regulation, and in October 2015 the European Parliament approved its own draft of the proposal. In 2016, the draft amendment passed into law (implementing regulation EU 1352/2011).

Key aspects of the amendment

Based in part on recommendations from experts at the Lethal Injection Information Center, the EU institutions designed the amendment in a way which avoids placing an undue burden on exporters or impeding legitimate trade. The Lethal Injection Information Center believes that any sustainable and proportional export regime must maintain legitimate access to medicines as a matter of priority.

Executing states are increasingly seeking to procure medicines which have never previously been used in executions. The amended regulation enables regulators to respond to these developments without creating a disproportionate burden on the manufacturers of these products.

There are three key elements of the amendment which carry particular importance for pharmaceutical manufacturers:

1. The introduction of a dedicated control list for “goods that could be used for the purpose of capital punishment,” primarily medicines sought for use in lethal injection;

Annex III of the regulation creates a specific category of controlled goods which are at particular risk of being purchased for use in capital punishment. The principal class of product included in this category is “Products which could be used for the execution of human beings by means of lethal injection” (Annex III, section 4).

Annex III controls the following products:

“4.1. Short and intermediate acting barbiturate anesthetic agents including, but not limited to:

(a) amobarbital (CAS RN 57-43-2)

(b) amobarbital sodium salt (CAS RN 64-43-7)

(c) pentobarbital (CAS RN 76-74-4)

(d) pentobarbital sodium salt (CAS 57-33-0)

(e) secobarbital (CAS RN 76-73-3)

(f) secobarbital sodium salt (CAS RN 309-43-3)

(g) thiopental (CAS RN 76-75-5)

(h) thiopental sodium salt (CAS RN 71-73-8), also known as thiopentone sodium”

For all products listed in section 4.1, European exporters are required to obtain an export authorization from the “competent authorities” in their state. Before granting such an authorization, the authority in question should seek to ensure the company has put in place supply chain controls which would prevent the product being diverted for use in executions.

The text of the Commission’s proposal for amending the regulation explained that:

“(T)he competent authorities should, when examining a request for an export authorisation, check whether there is a risk that the end-user in the country of destination would use the exported goods for such punishment. Appropriate conditions and requirements should be imposed to control sales or transfers to third parties by the end-user.”

2. The creation of global export authorizations for companies which have introduced effective controls, meaning the companies do not need to seek individual export authorizations for each shipment of medicines;

Every pharmaceutical manufacturer affected by this issue has voluntarily introduced watertight distribution controls which prevent their medicines being sold to death rows. In light of this, the amended regulation recognizes that if all companies exporting a medicine have effectively developed and enforced such controls, it would be disproportionate to subject them to further restrictions.

To minimize the regulatory burden placed on companies when exporting life-saving medicines, the amended regulation introduced a system of global export authorizations which apply for a period of up to one year, with the possibility to extend for another year. This means companies will not be required to seek individual export authorizations for each shipment of medicines.

To be granted a global authorization, companies will be required to demonstrate that they have appropriate controls in place to prevent the sale of these medicines for use in executions. Guidance provided by the Commission alongside its proposed amendment to the regulation specifies that:

“Granting a global authorisation would also be appropriate where a manufacturer needs to export medicinal products controlled by Regulation (EC) No 1236/2005 to a distributor in a country that has not abolished capital punishment, provided the exporter and the distributor have concluded a legally binding agreement requiring the distributor to apply an appropriate set of measures ensuring that the medicinal products will not be used for capital punishment”.

3. The introduction of an “urgency procedure” by which the European Commission can add medicinal products to the list of controlled products.

As controls imposed by manufacturers and regulators have prevented prisons from obtaining the “traditional” execution drugs listed in Annex III of the proposed amendment, some executing states are now seeking to procure medicines which have never previously been used in executions and which are not currently listed in the annexes.

This situation presents the risk that prisons may seek to import drugs which are not currently covered by the regulation, and attempt to build stockpiles of these unregulated medicines before EU institutions are able to restrict their sale. States can act quickly in changing execution protocols and procuring new drug supplies, presenting a narrow time window in which regulators may respond.

With this in mind, the amendment seeks to strike a balance between two imperatives: responding as efficiently as possible to prisons efforts’ to stockpile unlisted medicines for use in executions, while allowing for effective oversight of any decision to add these medicines to the regulation’s annexes.

Under the amendment’s Urgency Procedure (set out in article 15b), the Commission may immediately add a medicine to the list of restricted products in the annexes if it is being actively sought for use in executions. This provision would ensure states are not given a generous window of time to build their supplies while the annexes are being amended.

However, the amendment also provides for immediate repeal of any action taken by the Commission under the Urgency Procedure if either the European Parliament or the Council register an objection. The Parliament and Council have up to two months to make such an objection, and can request a two month extension to this period.

The proposed Urgency Procedure allows for immediate action at an EU level, and eliminates any procedural delay in restricting sales. But it also ensures that export controls can be applied consistently and with due consideration of patient access issues, allowing manufacturers to work alongside hospitals and patients to ensure their needs can be fulfilled.