Consultation guide on improving access to drugs and other health products in Canada: Discussion questions and key areas for action

On this page

• Key area 1: Improved communication and transparency
• Key area 2: Agile regulatory toolbox
• Key area 3: Greater supply chain visibility
• Key area 4: Enhanced response to supply and demand

Key area 1: Improved communication and transparency

The COVID-19 pandemic put a spotlight on drug and other health product shortages and the need to provide timely information to the public. Recent high-profile shortages like children's pain and fever medication, antibiotics, epidural catheters, and infant formula have further highlighted the need for everyone to work together to better communicate information on shortages. This includes:

• all levels of government
• health care systems and providers
• hospital and community pharmacies
• international partners
• academia
• patients and consumers
• manufacturers and distributors

Better communication and information-sharing can help all of us work together to identify solutions and mitigate health product shortages.

More than ever, people in Canada are playing an active role in the management of their health. Better and more timely information will help them:

• make informed health decisions
• discuss options with their health care provider in the event of a shortage
• understand all the actions that are being taken to resolve shortages as quickly as possible

Examples of activities in this area of action could involve:

• sharing more information about shortages that could affect people and their families
• improving Health Canada online information to better explain:
  • our role and that of other players in managing shortages
  • the nature and scope of shortages
  • what members of the public can do in times of shortage
• implementing a more systematic approach to information exchange with and among stakeholders working to respond to a shortage
  • For example, accurate demand information, distribution status, data on available products before stock out across the supply chain
• improving public information-sharing on the nature and scope of a shortage and on stakeholder actions to prevent and mitigate a shortage
• sharing disease surveillance information with industry so they can better plan for the next cycle of their drug production

Discussion

Questions for discussion:

• In the past year, have you looked for information on drug or other health product shortages?
• How do you obtain information you need related to a shortage?
• What are your biggest challenges in getting key information to help you deal with shortages?
• As a health care professional, what type of information could be useful for your patients when there's a shortage? How would this information be useful?
• As a member of the public, what information would you consider the most helpful when facing a drug or other health product shortage?
  • For example, why there's a shortage, the estimated start and end date of a shortage, alternative products that are available, information on distribution
• As an industry member, a health care provider or a provincial or territorial government, what processes do you have in place for information-sharing, communication and transparency during an anticipated or actual shortage?
• What are the biggest challenges you face in communication and transparency related to shortages?
• What information from the industry on a shortage would you like to know?

What can be done?

• What is the most effective way for you to receive information on a drug or other health product shortage?
• What type of information are you missing to respond to a shortage or shortage risk in a timely manner?
• What type of support is needed to improve information sharing?

Key area 2: Agile regulatory toolbox

Regulatory tools are an important part of a government's ability to manage shortages of drugs and other health products. Health Canada and provincial and territorial governments both have regulatory responsibilities in this area:

• federal regulations focus on the activities of market authorization holders
• provincial and territorial governments provide for health care and distribution of medicines to patients through the regulation of the practice of medicine and pharmacy

Regulatory innovation was an important element of Health Canada's response to the threats posed by the COVID-19 pandemic. The implementation and use of new regulatory authorities led to concrete results for people in Canada. For example, we were able to supplement the needed domestic supply of drugs, medical devices, and infant formula by permitting the importation of foreign-authorized products. Since April 2020, we have been able to de-escalate 72 of 98 national critical drug shortages.

To be effective, regulatory tools must keep pace with changes that affect the supply chain. It is also critical that we explore all opportunities to expand tools to help us gather additional information on supply and demand from supply chain players. In this way, we will be better able to assess supply, manage shortages and inform procurement practices across Canada. There are also opportunities to intervene where necessary to increase risk management or require practices that make the supply chain more resilient.

Given the global nature of drug and other health product shortages, it will also be important to align with other international regulatory partners who are taking steps to better respond to shortages.

Examples of regulatory actions could include:

• expanding the scope of the mandatory public shortage reporting framework, including for products not already covered by the existing framework
  • for example, some non-prescription drugs such as acetaminophen and ibuprofen
• creating a list of drugs that are vulnerable to shortages, enhancing availability of their supply and subjecting them to certain regulatory requirements
  • for example, additional supply beyond regular inventory (also called safety stocks)
• requiring risk management plans for shortages in certain situations
• promoting contracting practices and inventory management approaches to increase safeguards along the supply chain and improve emergency response

Discussion

Questions for discussion:

• What information or tools would better prepare you to prevent or mitigate the impacts of drug shortages? Why?
• What do you believe are the most frequent causes of shortages? What actions are you taking to prevent these causes from leading to a shortage?
• Do you have requirements to hold reserves or safety stocks for certain health products? If so, for which and in what quantity? What is the nature of these requirements (for example, regulatory, administrative good practices, contracting requirements)?
• What are the advantages and challenges to developing a list of drugs vulnerable to shortages?

What can be done?

• What other processes could you or your organization put in place to better prevent, detect and address the risks of a shortage for your products?
• What are the challenges to advancing these new processes?
  • for example, regulatory, market dynamics in Canada, financial, technological, capacity/expertise
• What kind of support would you need to advance such new processes?
• What are your views on how a vulnerable drug list should be developed? Who should participate in that process? How should the list be used?

Key area 3: Greater supply chain visibility

Important information on products, licence holders, patient needs, and supply and demand is collected at several points and by different sectors across the supply chain for drugs and other health products. These points in the supply chain range from fabricating an active pharmaceutical ingredient, to selling a drug in its final dosage form, to distributing it across the health care system and at retail outlets.

A lack of key information about the supply chain creates challenges for developing proactive measures to prevent and mitigate a shortage. Unexpected changes in demand, difficulty in accessing raw materials and disruptions in supply from other countries present challenges for Canada's supply.

The timely sharing of information between the various supply chain actors is critical if we are to anticipate and prevent shortages or mitigate them where this isn't possible. At present, there is room to improve how this information is collected and shared. Given the information resides within different systems, we need to find solutions to connect the information flows to improve its effective use.

There is a need to:

• explore ways we can use digital strategies to gather information across the supply chain
• take a multi-stakeholder approach to harness the power of data technology-enabled solutions that can address gaps in information-gathering, sharing and analytical capacity
  • stakeholders should include industry, governments and health care providers

Examples of actions in this area could include:

• collecting and using data from additional points in the supply chain to detect decreasing stock or changes in consumption patterns early on
• improving technology-enabled systems to allocate health products more efficiently during a shortage
• setting and implementing standards for collecting and sharing data to promote a rapid response to shortages across Canada
• enhancing analytics capacity (for example, IT infrastructure, use of artificial intelligence, expanded disease/virus modelling) to deploy mitigation efforts quickly

Discussion

Questions for discussion:

• What are your biggest challenges when it comes to supply chain or inventory visibility?
• What information can you or are you collecting on a regular basis about demand and anticipated changes to demand?
• What information do you collect as a health care professional or as part of your organization that could help other stakeholders address a health product shortage?
• What solutions would support improvements in your industry with respect to supply chain visibility?
• What concerns do you or your organization have when it comes to sharing information that would increase supply chain visibility with Health Canada or other supply chain partners?

What can be done?

• What initiatives in your profession/sector are under development to improve supply chain or inventory visibility?
• What solutions would support improvements for your profession/sector in this area?
• What challenges does your organization face in implementing strategies or technologies that could help increase visibility into your product supply chains?
• What kind of support would you need to advance such strategies or implement technologies to support greater visibility?

Key area 4: Enhanced response to supply and demand

Interdependencies in the global supply chain and many outside forces can impact the availability of drugs and other health products. This makes it nearly impossible to anticipate or prevent all shortages.

A resilient supply chain is able to recover rapidly from disruption and unexpected changes in supply and demand. This is supported by robust stocks of drugs and other health products, and the ability to respond quickly to challenges. Ramping up domestic production, catching up on delayed manufacturing after a plant failure or sourcing foreign-authorized products are all important components of preventing or mitigating a shortage. However, preventing or reducing the impacts of shortages means strengthening the health products ecosystem.

A more diverse market is more resilient. More diversity means more active ingredient suppliers, more manufacturers serving the Canadian market and more supply diversity for similar products, for example. It also means:

• stronger tools like better inventory management practices
• extra supplies above regular inventories, such as safety stocks at different points of the supply chain
• strategic procurement practices to rapidly access available products or
• agile importation and distribution across the country

Activities under this pillar could involve:

• encouraging expanded domestic manufacturing capacity for select drugs so that we have more than 1 producer for key drugs
• exploring the use of safety stocks and reserves for certain drugs vulnerable to shortages in Canada
• supporting incentives or commitments to good practices in procurement, distribution and allocation

Discussion

Questions for discussion:

• What do you currently do to prepare for changes in supply and demand of drugs or other health products?
• What barriers do you face in your efforts to be prepared for changes in supply and demand?
• When is it most useful to have safety stocks or extra supply in the supply chain?
• What factors determine how much safety stock is needed or which drugs should be buffered?

What can be done?

• What solutions would you propose to improve your ability to prepare for changes in supply and demand?
• What kind of support do you need to be better prepared to react to a rapid change in demand?
• What is the impact of the market environment on product diversity?
• What type of regulatory alignment would you see as beneficial to improve access to health products for people in Canada?
  • for example, with other international regulators, among provinces and territories across Canada
• How can we incentivize market diversity?