Resources

Pharma 101

A beginner’s guide to the research-based pharmaceutical industry

Developing an innovative medicine takes more than a decade and requires approximately $2.6 billion in investment.

The journey begins with preclinical research and narrows thousands of potential compounds down to the few that eventually enter clinical trials. Only a small fraction ever reach patients.

Phase 1

Preclinical Research

Researchers isolate 5,000 to 10,000 potential compounds and narrow them to roughly 250 for further study. This phase typically lasts three to six years.

Phase 2

Clinical Investigation

Researchers conduct in-depth investigations to further reduce the number of compounds before clinical testing.

Phase 3

Clinical Trials

Once preclinical and investigational work is complete, clinical trials can begin. These studies involve thousands of volunteers, scientists, physicians, and researchers.

The road from discovery to your medicine cabinet is long, complex, and costly – and success is never guaranteed. When a compound fails during trials, researchers return to the outset and begin again. Even successful new medicines face two years of regulatory review before reaching patients.

Innovative Medicines Canada advocates on behalf of the life sciences sector to accelerate innovation, protect patient safety, and ensure Canadians can access new medicines

Specialty medicines are revolutionizing healthcare

Personalized medicine is changing the way we treat disease. By examining a patient’s genetic profile, healthcare providers can select therapies that target specific conditions more precisely..

Biologics are complex medicines produced from living cells, such as blood components, proteins, or viruses. Unlike chemically synthesized drugs (e.g. aspirin), biologics are sensitive, intricate, and difficult to manufacture.

Biologics include:

  • Vaccines
  • Gene therapies
  • Stem-cell therapies
  • Tissue-based treatments

Some familiar biologics include Botox and Humira, used to treat arthritis and other conditions.

These therapies often deliver better outcomes and fewer side effects than traditional pharmaceuticals. Many treat conditions that had no effective options only a few years ago. Biologics also benefit the healthcare system by reducing complications, lowering costs, and improving productivity. Advances in genomics now allow scientists to identify genetic disease markers and engineer DNA, proteins, antibodies, and hormones with greater precision..

Biosimilars are highly similar versions of biologics whose patents have expired. Because biologics are made from living organisms, biosimilars cannot be exact copies and therefore cannot be classified as “generic.”

Health Canada describes biosimilars as:

“A biologic drug that is highly similar to a biologic drug that was already authorized for sale.”

When developed responsibly, where patient safety and intellectual property are protected, biosimilars expand treatment options and generate savings for public and private payers.

How Canadians access medicines

Most Canadians receive drug coverage through:

  • Private insurance plans (25 million Canadians[1] )
  • Provincial/territorial public plans
  • Out-of-pocket payments (a minority of Canadians)

A recent international comparison showed Canada ranks 15th of 20 countries on public financial coverage for new medicines.

Innovative Medicines Canada continues to work with governments, payers, and industry to improve equitable and timely access.

Public programs are paid for and administered by provincial and territorial governments. Most plans cover seniors, people receiving social assistance, and those with high drug costs or specific chronic conditions. Most also cover medicines administered in hospitals.

Private insurance helps employers support workforce health, retain quality employees, and demonstrate corporate social responsibility.

The Patented Medicine Prices Review Board (PMPRB) sets the maximum allowable price for patented medicines in Canada based on:

  • Therapeutic value
  • Prices of comparable products
  • International pricing

After PMPRB sets the acceptable limit, public plans and private insurers can negotiate pricing through the pan-Canadian Pharmaceutical Alliance (pCPA). Public plans also access value through the Canada’s Drug Agency (CDA) and, in some cases, provincial agencies.

Provincial and territorial governments face increasing pressure when setting health budgets and policy. Canada’s innovative pharmaceutical companies work with governments to improve access while supporting system sustainability.

Patient safety is our top priority

Every new medicine undergoes multiple levels of review, extensive clinical testing, and continuous safety monitoring after approval. Canada’s regulatory framework ensures medicines are safe, effective, and used appropriately under the guidance of healthcare professionals.

Innovative Medicines Canada collaborates with partners across the healthcare system to support safe, informed use of prescription and over-the-counter medicines.

resources

Discover. Learn.
Understand.

Stay informed with timely, relevant content on key issues shaping our industry.