|
Drugs for compassionate useMost countries allow patients access to unlicensed drugs when all their other options have run out. This is often referred to as "compassionate use", although most government programs do not use that phrase. Below is some information on how to access these programs for various countries. if you have information about this program for your country please e-mail the webmaster.
CANADAThe Special Access Programme (SAP) has a mandate to provide access to
non-marketed drugs to practitioners treating patients with serious or
life-threatening conditions when conventional therapies have failed, are
unsuitable, are unavailable or offer limited options. Ultimately, SAP provides
the authority for a manufacturer to sell a specific quantity of a drug and
therefore grant access to a drug which cannot be otherwise sold or distributed
in Canada. The scope of drugs considered for release by SAP includes
pharmaceutical, biologic, and radiopharmaceutical products that are not approved
for sale in Canada. SAP does not grant authority to use or administer a drug -
this authority is considered to be within the practice of medicine which is
regulated at the provincial level.
To initiate a request a practitioner may write, telephone, fax or e-mail the Special Access Programme:
Special Access Programme
Calls to this emergency service should be limited to requests for drugs or blood products requiring immediate or overnight drug delivery.
Main Health Canada Website http://www.hc-sc.gc.ca/english
Special Access Program (SAP) web site http://www.hc-sc.gc.ca/dhp-mps/acces/index_e.html
UNITED STATESPrepared by the Food and Drug Administration, Office of Special Health Issues
Introduction The acronym "IND" refers to an Investigational New Drug application, which is an application to the Food and Drug Administration (FDA) to administer an investigational new drug or biologic product to humans. Since a biologic is also considered a drug, the term "drug" as used in this document refers to either a drug or a biologic product.
Most human use of investigational drugs takes place in clinical trials conducted to assess safety and efficacy of those drugs. Consequently, FDA's IND processes are designed primarily for drug companies and medical researchers engaged in clinical development of new drugs. However, some patients not eligible to participate in a clinical trial may benefit from treatment with an investigational drug under study. For such cases, FDA has developed numerous regulatory mechanisms to make investigational drugs available outside of clinical trials. These mechanisms include single-patient INDS, emergency INDS, and treatment INDs/protocols.
Single-Patient INDs and Emergency INDs In many cases, the investigational drug will not be available through an expanded access program from the manufacturer. For such cases, the discussion below addresses how a physician can file a single-patient IND or an emergency IND for treatment of a patient with an investigational drug. In the case of a single-patient IND or an emergency IND, all of the following conditions must be met before FDA can allow a physician to administer an investigational drug under a single-patient or emergency IND:
All Biological IND submissions must be made in triplicate and should be addressed as follows:
Center for Biologics Evaluation and Research
Additional information and and all forms may be obtained at the FDA's Center for Bioloics Evaluation and Research (CBER) web site http://www.fda.gov/cber/ind/ind.htm
Additional FDA information about the IND program can be found at Investigational New Drug Application process
UNITED KINGDOMMedicines legislation (specifically The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994/SI 3144) requires that medicinal products are licensed before they are marketed in the UK. However, some patients may have special clinical needs that cannot be met by licensed medicinal products. So that these special needs may be met, the law allows manufacture and supply of unlicensed medicinal products (commonly known as "specials") subject to certain conditions.
The conditions are that there is a bona fide unsolicited order, the product is formulated in accordance with the requirement of a doctor or dentist registered in the UK, and the product is for use by their individual patients on their direct personal responsibility. If a "special" is manufactured in the UK, the manufacturer must hold a manufacturer's (specials) licence issued by the MCA. A "special" may not be advertised and may not be supplied if an equivalent licensed product is available which could meet the patient's needs. Essential records must be kept and serious adverse drug reactions reported to the MCA. Click here to go to the MCA drug exemptions page
Contact for further information For further information about the manufacture and supply of "specials" for individual patients, please contact the
Policy Unit, Inspection and Enforcement Division Medicines Control Agency main web site
AUSTRALIAThis part of the page is still under construction. If you have information on
this programme for Australia please e-mail it to the webmaster at:
webmaster@nhlcyberfamily.org
|