Bart Stapert vs. Mylan

Date filed: 3 March 2015

Current status

Agreement

Sector

Other

NCP

NCP The Netherlands

Allegations

Pharmaceutical company Mylan produces generic medicines, including rocuronium bromide, which has been used as part of a lethal injection to execute death penalty inmates in the United States. Attorney Bart Stapert filed a complaint against Mylan for failing to take action to protect its medicines from being used in executions. By failing to do so, the complainant alleges that Mylan breached a number of OECD Guidelines provisions and is at risk of complicity in a number of human rights abuses, including capital punishment (a violation of the right to life) and torture or other cruel, inhuman or degrading treatment or punishment.

Mylan moved its headquarters to the Netherlands in 2015 because of fiscal reasons. While lethal injection executions of prisoners using experimental drug cocktails is taking place in the US, not the Netherlands, the complaint argues that the Dutch NCP nevertheless has the responsibility to handle the case as it is related to a Dutch companys role in a process leading to such serious human rights abuses.

The complainant requests that Mylan investigate what distribution controls it can impose to prevent the sale of its medicines to prisons for use in executions while maintaining access for legitimate medical users. Furthermore, he recommends that Mylan take active steps to implement such controls and try to prevent the use of any Mylan medicines which may already have been sold to prisons in executions. Finally, the complainant encourages Mylan to publish a policy statement confirming Mylans commitment to human rights, in particular in relation to the human rights abuses associated with the use of medicines in lethal injection executions.

Relevant OECD Guidelines

Outcome

The NCP has contacted both parties in the process of formulating its initial assessment and concluded the complaint merits further consideration in July 2015. The parties accepted the NCP´s offer to faciliate mediation.

In November 2015, the NCP convened the first joint meeting of both parties to discuss the specific instance. A second meeting was held in February 2016. As a result of these meetings, the NCP and the parties agreed to wind up the mediation process and draft a final statement, given the steps agreed to and taken by Mylan.

The NCP published its final statement in April, 2016. The dialogue facilitated by NCP resulted in an agreement between the parties on the non-primary functional use of medicine in general and rocuronium bromide in particular, in capital punishment. The parties further agreed to continue a constructive dialogue on this matter.

The NCP recommends that in March 2017 an evaluation be conducted of the outcomes of the dialogue, to ensure that Mylans products are being used properly and prevent use of medicine in lethal injections.

On 18 July 2017, both parties met with the NCP to evaluate the outcome of the dialogue. The NCP released an evaluation report outlining the steps that were made by Mylan since the agreement was initially made. Both parties felt that the dialogue facilitated by the NCP had been productive and resulted in tangible benefits for both parties and they agree to maintain a constructive dialogue in the future. The NCP urges all pharmaceutical companies to be alert in this changing landscape, take new steps if necessary and check on a regular basis if controls put in place are really working.