BC Supreme Court Re-establishes Access to Diacetylmorphine (Heroin) Assisted Treatment

VANCOUVER, May 29, 2014 — The Supreme Court of British Columbia has re-established access to diacetylmorphine (heroin) assisted treatment following an injunction application by Providence Health Care (Providence) and the PIVOT Legal Society on behalf of five patients who had exited the SALOME (Study to Assess Longer-term Opioid Medication Effectiveness) study.

We are pleased with the court’s decision to allow SALOME patients to continue to access care and support,” said Health Minister Terry Lake. “We need to let science and research inform the services that we provide. The evidence has shown that the SALOME trial has effectively treated long-term heroin-dependent individuals.”

The court has put the urgent needs of vulnerable patients first,” said Dianne Doyle, President and CEO of Providence. “These patients have tried other treatments, such as methadone and detox, numerous times, but such treatments have not been effective. Diacetylmorphine (heroin) assisted treatment is a proven treatment option that is a last resort for people who have tried all other treatment options without success.”

In his decision, the Honourable Chief Justice Christopher Hinkson stated: “I accept that the potential harms facing the personal plaintiffs, and those on whose behalf they apply, are grave…SAP applications are considered and either approved or disapproved by those with expertise in both addictions and drug safety issues. In light of the seriousness of the potential harms facing the applicants, I am persuaded that the balance of convenience in this case favours those for whom such applications for injectable diacetylmorphine were approved on terms and conditions prior to the enactment of the impugned provisions, or those whose applications may have been so approved had such applications been made prior to that enactment.”

The legal action followed Federal Minister of Health Rona Ambrose’s October 3, 2013 changes to federal regulations making diacetylmorphine a restricted substance under the Food and Drug Act, preventing it from being available through Health Canada’s Special Access Programme (SAP).

SAP is designed to let patients in exceptional cases get medications normally not available in Canada. This access is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable. Through SAP, Providence doctors had requested – and received – access to diacetylmorphine for 21 of the participants exiting the SALOME research study in Vancouver, before the regulations closed off access to this treatment.

On November 13, 2013 Providence and PIVOT launched a constitutional challenge to overturn the federal government regulations. The challenge requested, among other things, a declaration that the new federal government regulations infringe on the Charter Rights, are unconstitutional, and should be struck down.

The patient plaintiffs are David Murray, Deborah Bartosch, Larry Love, Douglas Lidstrom and Charles English.

Patients within the SALOME study were unaffected by the regulation because permission had previously been obtained by Health Canada, but diacetylmorphine could not be used for clinical care for patients no longer in the study. SALOME is a clinical study, headed by Providence’s Centre for Health Evaluation and Outcome Sciences researchers, that tests alternative treatments for people with chronic heroin addiction who are currently not benefiting sufficiently from available treatments such as oral methadone.

SALOME compares two similar medications – diacetylmorphine, the active ingredient of heroin, and hydromorphone (HDM), a legal, licensed pain medication. The study aims to determine alternative treatments for people with chronic heroin addiction not benefiting sufficiently from available treatments such as oral methadone. The three-year trial is being completed in phases. So far, 190 of 202 participants have finished SALOME. Some of them have been transferred to methadone or drug-free programs and others onto oral HDM. Others critically require diacetylmorphine (heroin) assisted treatment.

The science supports this course of treatment. Six similar trials comparing medically-prescribed heroin and methadone (including NAOMI), involving more than 1,500 patients, have provided unanimous evidence in support of the effectiveness of this treatment for long-term heroin-dependent individuals. Data is available from six countries: Switzerland, the Netherlands, Spain, Germany, the United Kingdom and Canada. Heroin-assisted treatment has been officially adopted in the United Kingdom, Switzerland, Germany, Denmark and the Netherlands.

Providence has retained Joseph Arvay as legal counsel in the court action. Arvay is a renowned Canadian lawyer who has argued numerous landmark cases involving civil liberties and constitutional rights, including Vancouver’s Supervised Injection Site case in the Supreme Court of Canada. The patients joining the action are represented by the Pivot Legal Society.

Pivot Legal Society is a Vancouver Downtown Eastside-based non-profit organization that advocates on behalf of marginalized communities and persons across Canada through strategic litigation.

For more information on this decision and the constitutional challenge, please click here.

Providence Health Care (PHC) is one of Canada's largest faith-based health care organizations, operating 16 health care facilities in Greater Vancouver. PHC operates one of two adult academic health science centres in the province – St. Paul’s Hospital – performs cutting-edge research in more than 30 clinical specialties, and focuses its services on six “populations of emphasis”: cardio-pulmonary risks and illnesses, HIV/AIDS, mental health, renal risks and illness, specialized needs in aging and urban health and is home to the B.C. Centre for Excellence in HIV/AIDS. www.providencehealthcare.org

For more information:

Dave Lefebvre
Senior Communications Specialist – Media Relations
Providence Health Care
dlefebvre@providencehealth.bc.ca
Tel:  604-682-2344 extension 66987
Cell: 604-837-6003 (c)

Adrienne Smith
Lawyer, Pivot Legal Society
adrienne@pivotlegal.org
(778) 866-6952

Read more on the SALOME Heroin Legal Challenge page.