The Canadian gov. has put the drug price system on hold

Health Canada to draw up new guidelines,

The re-evaluation of contract for re-evaluation was virtually canceled

Korea to add Canada to drug price reference country this year...The domestic drug price reduction variable disappears.

 

The reorganization of the drug price system, which was promoted by the Canadian government, has been temporarily suspended.

 

Analysts say that the Canadian Ministry of Health officially announced that it would come up with a new reform plan due to strong opposition from the local pharmaceutical industry and that the plan to reevaluate the prices of premium drugs has virtually been canceled.

 

Canada's move is also expected to affect South Korea's decision on the price of salaried drugs.

 

In Korea, Canada has been added to the drug price reference country since this year.

 

◆ Canada's Ministry of Health decided to temporarily suspend the implementation of the drug price reform plan According to the pharmaceutical industry on the 14th, Health Canada recently requested the PMPRB (Patented Medicine Prices Review Board) to suspend the implementation of the drug price guideline reform plan.

 

PMPRB has pushed for a reform of the patented drug price system since 2019.

 

The reform plan focused on lowering the price of excessively high patented drugs.

 

The core of the reform plan is to give the authority to investigate and re-evaluate ex officio whether the price of previously listed patented drugs is not expensive.

 

To this end, a new price regulation device was added.

 

It adds pharmacoeconomic value, including cost-effectiveness analysis data, the size of the drug market in Canada, Canada's gross domestic product (GDP), and per capita GDP.

 

캐나다 보건부는 작년 6월 새로운 지침을 시행하겠다고 예고했으나(위), 최근 새로운 지침은 2023년 1월 1일에 시행되지 않는다고 밝혔다(아래).

 

캐나다 보건부 홈페이지 캡처

On top of that, the drug price reference countries were reorganized into 12 countries, including Korea, Japan, Australia, Belgium, the Netherlands, Norway, Spain, France, Germany, Italy, Sweden, and the United Kingdom.

 

The existing U.S.

 

and Switzerland were excluded.

 

The intention is to lower the average price of foreign drug prices by excluding the U.S.

 

and Switzerland, which have high drug registration prices.

 

Ministry of Health estimated that $13.2 billion could be saved over the next 10 years by reforming the drug price system for the first time in more than 20 years.

 

▲Canada's Health Ministry announced in June last year that it would implement the new guidelines (above), but recently announced that the new guidelines will not take effect on January 1, 2023 (below).

 

Capture Health Canada However, the implementation of such a reform plan has been delayed.

 

It was originally scheduled to take effect in January 2020, but it was implemented on July 1 last year after four delays due to opposition from the Canadian pharmaceutical industry and the influence of COVID-19.

 

The most strongly opposed part of the industry's re-evaluation of the price of such drugs was scheduled to take effect on January 1 this year after preparing a new plan with a grace period.

 

The industry has consistently protested, and in the end, Canada's Ministry of Health has decided to suspend the reform of the drug price system, saying it needs more review.

 

At the same time, he said he would come up with a completely new version of the reform plan.

 

Temporary guidelines are expected to remain in place until a new reform plan is prepared.

 

◆The new drug price reference country Canada's drug price cut variable disappears There have been constant concerns in the domestic pharmaceutical industry that the implementation of the new drug price system in Canada will lead to a reduction in drug prices in Korea.

 

Canada was added as a new drug price reference country this year.

 

As of January 1 this year, the country subject to foreign adjusted average price calculation has been reorganized from A7 (Japan, France, Germany, Italy, Switzerland, the United Kingdom, and the United States) to A8 with Canada added.

 

The government has expressed its willingness to refer to the drug prices of A8 countries for the reevaluation of quality medicines as well as the registration of new drugs.

 

In this situation, concerns have been raised that if the Canadian drug price decreases, the Korean drug price referring to it will also decrease.

 

However, as Canada's reorganization of the drug price system has been temporarily put on hold, it is interpreted that variables that will affect Korea's reduction in drug benefit prices have also disappeared.

 

In response, a pharmaceutical industry official said, "It is welcome that the potential risk factors that will lead to a domestic drug price cut have disappeared," but added, "However, since the Canadian government is still willing to cut drug prices and has decided to come up with a new reform plan, we should carefully look at future changes."