Getting Your Regulatory Affairs Certification? Canada’s Special Access Program May Interest You

Working with regulatory systems requires a strong background in standards and regulations, so that you have a good understanding of how they function and how they can change. Pharmaceutical regulations dictate how Canadians can access the drugs that they need to be healthy and enjoy a high quality of life.

When regulations are made, it is often to improve the process by which people receive their pharmaceutical products and make healthcare more effective. In the case of Canada’s Special Access Program, patients who haven’t been able to receive effective treatment with conventional therapies are given access to drugs not normally available in Canada. This helps patients get the care they urgently need in a way that can help them. Read on to learn a little more about the Special Access Program (SAP) in Canada!

Know What Is Available Through the SAP

The SAP can give patients access to pharmaceuticals that they normally aren’t allowed to access in Canada. These drugs might be:

• Pharmaceuticals
• Radiopharmaceuticals
• Biologics
• Genetic therapies

Patients can sometimes access drugs that aren’t available normally in Canada, if the SAP approves

The SAP is who doctors will contact to see if they are allowed to access a drug that Canada doesn’t have for a patient who needs it. When other therapies haven’t been working, or when those medicines are unavailable to the patient for some reason, obtaining drugs from other countries may be the next step. Students in regulatory affairs programs may feel passionate about this ability to provide patients with the care they need in emergency situations. There are some things that aren’t accessible through the SAP, but there are other routes that can be taken and programs to use if they are needed. The SAP can’t grant access to:

• Restricted drugs (or products that have restricted drugs in them)
• Veterinary pharmaceutical products
• Medical marijuana
• Drugs that are needed to conduct research

It is also possible to access medical devices from outside of Canada through the Special Access Program—these medical devices, like drugs, can be requested only when:

• There is an emergency situation with a patient
• Conventional treatments are not working on a patient
• Standard therapies are either not appropriate for a patient or aren’t available to them

How SAP Requests Are Made: An Explanation for Students in Regulatory Affairs Programs

Drugs are requested through the SAP by medical practitioners. There is a Special Access Request form that is used for this process.

• The form is submitted to the SAP
• Risk management is a large part of the screening and assessing process done by the SAP, including:
  • Known risks
  • Alternatives that are available on the market
  • Standards of manufacturing and other product information
  • How much evidence there is on the effectiveness of the treatment and what stage the drug is in for
  • development

If drugs are authorized, the request is processed.

Physicians might request drugs through the SAP if their patients need them

Recent Changes to the SAP that Occurred in May 2019

Unauthorized drugs from foreign countries are pre-positioned now, which means that an amount of them can be imported and held on standby for patients who need them. This makes the process of obtaining drugs much more efficient. Instead of having to order the drugs from the external sources as needed, this system allows for there to be an inventory of some drugs already on hand in Canada.

• Health Canada authorizes the importing and pre-positioning of drugs
• Health Canada issues a letter authorizing importers to give the drug to practitioners
• This is a more efficient process and gives faster access to drugs

These changes are particularly beneficial in any serious situations where a patient’s life is in danger without access to the drug. If you work in pharmaceutical regulatory affairs, you can feel good about contributing to a sector that helps save lives in this way.

The SAP allows for hope to be given to patients for whom conventional therapies aren’t working

Are you interested in a regulatory affairs certification?

Contact AAPS to learn more.