Read the initial assessment issued by the Dutch NCP – 17 July 2015
Read the final statement issued by the Dutch NCP – 11 April 2016
Read the evaluation statement issued by the Dutch NCP – 27 September 2017
On 3 March 2015, the Dutch NCP received submission by Mr. Bart Stapert regarding alleged human rights impacts by Mylan N.V. in respect of the manufacture of rocuronium bromide and links to lethal injection execution through sales of the generic medicine in the United States.
Mr. Bart Stapert is an attorney with expertise in the defense of capital punishment cases. In the submission he alleges that Mylan’s failure to restrict the sale of its products to prisons in the United States risks enabling the execution of prisoners using rocuronium bromide in violation of their right to life and, potentially, their right not to be subjected to cruel, inhuman and degrading treatment. The submission refers to alleged non-observance of the General Policies chapter and the commentary on Human Rights in the Guidelines.
In the view of Mr. Bart Stapert, Mylan should acknowledge the risk that without distribution controls in place its medicines may be purchased by prisons in the United States and used to execute prisoners, investigate what distribution controls it may impose, take swift action to implement comprehensive distribution controls, try to prevent the use of any Mylan medicines which may already have been sold to prisons and publish a policy statement confirming Mylan’s commitment to human rights, in particular to the human rights abuses associated with the use of medicines in lethal injection executions.
On 21 April 2015, Mylan submitted an initial response following the submission by Mr. Bart Stapert concerning the issues raised in this specific instance. The company states that it has never delivered, marketed or distributed rocuronium bromide for use in lethal executions, nor received or filed an order from any prison or other entity for use of the medicine in connection with a lethal injection. The company also challenged the jurisdiction of the Dutch NCP stating that the submission ought to be heard by the US NCP. Furthermore, the company contends that the demanded measures to be taken are beyond its control and that the issue is more one of ethical and public policy debate.
The initial assessment of the Dutch NCP concluded that the issues raised merited further consideration and the Dutch NCP therefore accepted the specific instance and offered its good offices to both parties. The Dutch NCP noted that, although in principle a notification should have been filed at the NCP where the alleged problems were occurring (in this instance the United States), the NCP has consulted with the US NCP and agreed that the Dutch NCP will handle this specific instance to affect change at the highest corporate entity in the Netherlands.
Both parties accepted the NCP’s offer to engage in mediation and met in November 2015 to start a dialogue facilitated by the NCP aimed at resolving the issue at hand. The parties agreed to continue a constructive dialogue after the meeting. The NCP has made some recommendations in addition to the due diligence recommendations in the Guidelines and closed the specific instance on 11 April 2016 by publishing a final statement.
The NCP is of the opinion that distributors and purchasers of, in this case, medicines distributed or purchased for purposes that are inconsistent with approved labelling and applicable medical standards of care fall under a business relationship. The NCP concludes that the Guidelines are applicable to both the supply chain and the distribution chain.
The NCP encourages pharmaceutical companies to work with different stakeholders such as distributors, human rights organisations and others to prevent rocuronium bromide and other medicines being used in lethal injections and suggests that Mylan shares the outcome of this matter and its due diligence steps with other companies in the sector.
The NCP conducted an evaluation to assess the outcomes of the mediation in September 2017 and found that the agreement had been fully implemented.