The head of a patient group claimed that the health authorities should provide low-income patients easier access to highly-priced new medicines to save more lives.

Ahn Gi-jong, head of the Korea Alliance of Patients Organization, expressed his opinions at a debate how to guarantee patients’ quick access to expensive new drugs, hosted by Rep. Jung Choun-sook of the ruling Democratic Party at the National Assembly, Monday.

“Patients’ access to a new drug, directly linked to life, is a fundamental right explicitly stated in the Constitution,” Ahn said. “End-stage cancer patients who are dying because they can’t use a new drug are like the victims of the Sewel ferry incident in the sense that they could die even though there might be a way to live.”

Ahn said low-income patients die without being able to try a new drug. “It is not difficult or complicated to fix this problem. If we change the current system a little bit, we can solve it,” he said.

Experts in the healthcare industry and government officials participate in a debate how to guarantee patients’ quick access to expensive new drugs at the National Assembly, Monday.

Ahn demanded the Ministry of Food and Drug Safety give conditional approval to a drug candidate after a phase-1 clinical trial. He suggested solutions such as a fast-track health insurance registration system, a hike of medical expense subsidy in a disaster from 20-30 million won ($17,700-$2,650) to 50 million won, a mandatory program to provide certain drugs for free, and expansion of experts for new drug approval and reimbursement.

Only after saving patients, the government and pharmaceutical firms should negotiate and set the prices of new drugs, he said. “There should be a social discussion and consensus on the use of life-saving new medicines,” he added.

Choi Seong-cheol, president of the Citizens’ Solidarity to Fight Cancer, said patients’ lives should not become a tool for price negotiations of new drugs.

“It is difficult to meet the needs of patients who want to try new drugs and reduce the government’s financial burden in health insurance at the same time. However, if the state health insurance is to improve people’s health, not to cut finance, the government should start discussing how to help patients use innovative medicines,” Choi said.

“Korea is not the only country facing the issue of high drug prices. The nation will need international cooperation,” he added.

On the other hand, Janssen Korea’s director Lim Kyung-hwa, who represented the Korean Research-based Pharma Industry Association (KRPIA), said it was more important to set the right prices for new drugs through economic evaluation, rather than to introduce a new system.

“The government has adopted various measures to raise patients’ access to new drugs, and people are still talking about a need for a new system. However, before this, we have to solve the fundamental problem,” Lim said. “Even though Korea conducts an economic evaluation on a new drug in the new drug registration process but it does not reflect the full value of a new medicine.”

She stressed that if a Korean unit of a global drugmaker fails to reach a certain price for a new drug after the government’s economic evaluation, the head office does not approve the price of the drug.

“Other countries are increasingly referencing drug prices in Korea. The more Korean drug prices affect those in China and Canada after local economic evaluations, the more Korean people will find it difficult to use new drugs at the current level of prices,” she added.

Kwak Myung-sub, director of Pharmaceutical Benefits Division at the Ministry of Health and Welfare, emphasized that the government cannot help but consider the health insurance spending.

“If we have limitless finance, we can provide new drugs as soon as possible. However, in a financially limited situation, we have to think of a reasonable allocation of resources,” Kwak said.

He also said that the government was reviewing the risk-sharing agreement (RSA) system, initially aimed to help patients use expensive drugs.

“Many people have asked us to expand the list of drugs under the RSA program to anticancer treatments and orphan drugs. In Korea, anticancer or orphan drugs can be the subject of the RSA through the review by the drug reimbursement evaluation committee, but there are no detailed criteria,” Kwak said. “We’re reviewing the criteria.”

In an RSA renewal negotiation with a drugmaker, the government’s priority is to protect patients, Kwak explained. However, if the two fail to reach an agreement or the company refuses to supply drug after the drug becomes a generic drug, protecting patients could become challenging, he said. “Protecting patients will be the key task in implementing the RSA system,” he added.

Kwak said the patient group head Ahn’s demand to register the new drug first and negotiate the drug price later would not be feasible. “It will not be a fundamental solution. Pharmaceutical companies won’t agree with such idea because it can make drug pricing more uncertain,” he said.

He went on to say that it was difficult to come up with measures to protect patients. “We are internally reviewing it, but it won’t be easy to introduce it.”

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