How Are New Medicines Approved in Canada?

By  //  September 13, 2020

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governmental regulations affect drug prices

Millions of patients from abroad, including the USA, prefer to buy medications at Canadian pharmacies, since in this country drug prices are reasonable and affordable, due to governmental regulation.

Millions of patients from abroad, including the USA, prefer to buy medications at Canadian pharmacies, since in this country drug prices are reasonable and affordable, due to governmental regulation.

Still, many customers have some doubts related to quality issues, since the difference in prices at local drugstores in their countries and in Canada is frequently shocking.

For example, if to compare drug prices in Canada and in the USA, the difference will reach 70% and even more in some cases, according to the statistics shared by Bchealth.com that has been collecting the data for the past 20 years.

So, we have gathered answers to all the basic questions about approving medicines in Canada, so that you can see that this process is reliable enough.

What Organization Is Authorized to Approve New Medications in this Country?

That is Health Canada, to be more precise ― the Health Products and Food Branch. They are responsible both for reviewing new medicines and for monitoring them after they are introduced to the market.

They are authorized to control all the categories of products and devices that are used for diagnosing and treating health problems, including:

• prescription and OTC medicines;

• vaccines and other goods manufactured with the help of biotechnology;

• tissues;

• disinfectants and sanitizers;

• radiopharmaceuticals;

• medical tools and appliances.

How Are Medicines Invented There?

Development procedures are similar in the overwhelming majority of countries.

In many cases, they are sponsored and supported by pharma manufacturers that strive to be the first to introduce innovative products and to get patents in order to be the only company to make money out of the corresponding new treatment solutions.

The process starts with developing a new active substance ― chemical or biological. To find out whether it causes the therapeutic effect needed, it is applied to tissues or to certain animals.

In case the scientists working on the project see that results are positive, they conduct a series of tests to determine the dosage required to get the desired effect.

And only if these tests prove that the new substance provides the effect needed without being too toxic, the sponsor of the research can turn to the HPFB.org in order to get approval for clinical trials.

Clinical trials involve volunteers that agree to get exposed to the new substance. Certainly, all the patients that get access to the would-be drug at this stage are being thoroughly informed about all the related health risks. This development stage involves scrupulous control and surveillance.

As a result of such trials, the researchers find out whether the new medication is effective enough and whether its therapeutic effects outweigh the risk of negative consequences. Also, the team of the project gets more precise information on optimal doses – according to the official website of the Government of Canada.

What Is the Next Step After Trials?

If the medication passes clinical tests successfully, the sponsor of its development can apply to the Health Products and Food Branch in order to get permission to distribute the corresponding product on the local market.

Then authorized specialists thoroughly analyze its effectiveness and safety. They are provided with results of both preclinical and clinical tests, information about potential health benefits and possible side effects and even details about production processes, packaging and labeling.

In some cases, the authority takes additional precautions and involves external experts in the process.

In addition, some biological products are tested in laboratories before being approved. However, such tests can be conducted after authorization as well.

If the authority decides that the benefits provided by the new product outweigh the possible health risks (or that the latest mentioned can be diminished), the sponsor of the trials gets permission to make this medicine available to customers.

Certainly, in case the medication passes trials abroad, it can also be introduced in Canada.

On average, the revision of a new medication takes 2–4 years. That depends both on the peculiarities of the particular products and on the workload that specialists from the HPFB need to cope with.

Sure, there are certain categories of drugs that are paid attention to and reviewed in the first place. These are products intended for treating severe and life-threatening diseases that can be currently treated with a very limited range of medicines only. Some examples of such conditions include oncology and AIDS.

As you can see, to introduce a medication to the local market, a manufacturer is required to pass a complex revision and approval process. The government in this country takes proper care of the safety and effectiveness of medications and other healthcare goods that are made available to citizens.

By the way, you have probably heard that some American politicians, including the current president, actively promote the idea of drug importation from Canada, while buying drugs from abroad is generally prohibited in the USA (except for certain cases when patients bring medications to the country for personal use only).

No doubt, the main purpose of this initiative is to solve the problem of unbearably high prices set by manufacturers for US consumers. But the fact that multiple influencers and experts want to make an exception for Canada is a sign that they consider medicines offered by local pharmacies to meet high-quality standards.

When Are Medications not Approved?

If the specialists working on the new drug fail to prove that it is effective and safe enough, they do not get permission to launch it in Canada. Sure, there is an opportunity to provide additional data or to submit for the approval again later. Also, the sponsor of the project can ask the authorities to reconsider the application and the decision.

Should Drug Prices Also Be Approved?

In contrast with the situation in many other countries, in Canada, drug prices are regulated by the government ― to be more precise, by the Patented Medicine Prices Review Board.

This governmental commission is responsible for controlling pharma companies in order to make sure they do not raise their prices too high. Their main purpose is to protect Canadians from unreasonable overcharges demanded by monopolists, i.e. companies owning patents on new drugs.

The board sets the maximal price level for each and every brand medication. Manufacturers do not have the right to exceed it. However, if a pharma company does not agree with this limit, they can try to solve that problem in the court. But producers cannot just ignore those limitations. They are obligatory to follow.

In order to determine acceptable prices for drugs, the authorities analyze prices of similar products in Canada or prices of identical items in other countries with similar economic conditions.

By the way, national and provincial authorities also conduct negotiations with manufacturers in order to get additional discounts. So, final prices are usually even lower than the maximums determined by the PMPRB.

As for generics, prices of such copies are also kept to a minimum, due to bargaining. Local authorities enter into agreements with manufacturers. By the way, in this country, both doctors and patients give preference to cheaper generics, whenever it is possible.

How Are Medications Controlled After Being Introduced to Customers?

No doubt, the government keeps on scrupulously controlling the efficiency and safety of all the healthcare products even after their manufacturers pass all the approving procedures.

The HPFB constantly monitors the situation on the market and keeps track of customers’ feedback and reports about negative effects and other problems. Also, they are authorized to initiate a recall under certain circumstances.

Producers and distributors, in their turn, are obliged to report any newly-acquired information about the therapeutic effects or side effects of drugs. If there is any research that provides new data concerning the safety of products approved, distributors must also inform the corresponding authorities about that.

Certainly, in case a manufacturer wants to introduce any significant changes to production processes, a recommended regimen or other usage details, receiving approval is a must.

More to the point, the HPFB is authorized to license the majority of production sites in the country, and, consequently, they have the right to inspect them.

To sum up, Canada is the country with a well-developed and effective system of drug quality assessing and monitoring. So, if you live in the country with bloated drug prices, like the USA, turning to Canadian pharmacies is the perfect saving solution for you.

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