“RSA expansion, a foundation to expedite new drug listing"

Interview on Chair Avi Benshoshan of KRPIA

“Engaging with government for patient-centered healthcare policy”

“To fully support clinical studies for the development of Korean pharmaceutical industry”

A ‘new drug’ holds the foremost value of the pharmaceutical industry.

 

And global pharmaceutical companies’ eyes are currently fixated on the ‘adequate value of new drug’ than ever before.

 

As the era of high-cost drug has come, government and pharmaceutical industry’s gap in views of drug pricing has never been so apart.

 

Korea Research-based Pharmaceutical Industry Association (KRPIA), representing the voices of global pharmaceutical companies in Korea, is stepping forward seeking the middle ground of the two.

 

A consensus between them does exist.

 

For an instance in last year, the Korean health authority expanded scope for risk sharing agreement (RSA) and announced a plan to apply RSA on follow-on drug and to expand pharmacoeconomic evaluation (PE) exemption system.

 

The year 2020, the time of changes and expectations, marks Chair Avi Benshoshan’s third year serving KRPIA.

 

And Daily Pharm interviewed him for this year’s plan of the organization.

 

Chair Avi Benshoshan

#- New Year’s greetings and message for the member companies. As you may be aware, this year would be another year of economic recession and sluggish growth as predicted by major economic indicators.

 

However, we hope to create a regulatory environment that recognizes value of innovation to maintain the growth engine of pharmaceutical and bio industry this year as well.

 

And I wish everyone has a year full of keen wisdom to seek an opportunity in crisis, like a small but bright mouse.

 

- KRPIA member companies share a common theme of ‘new drug.’ But each of them has diverse field of expertise in anticancer, rare disease, chronic disease and off-patent treatments, which comes with different interest groups.

 

Respective member companies have their own specialized field, but in a bigger frame, they are all heading for the same goal of improving patient’s health.

 

In the same sense, KRPIA is planning to present more concrete basis for new drug to strengthen the ‘patient-centered healthcare policy,’ and to reinforce the organization’s role as a communicator between government and healthcare sector stakeholders.

 

The organization ultimately aims for a mutual growth through raising awareness of social value in new drug and improving policy.

 

We think the government, global pharmaceutical companies and the organization also share a same goal of adequately providing new drug to patients in urgent need and lowering barrier of new drug access to prevent disheartening catastrophe of patients giving up on treatment for financial reasons.

 

- It could be considered quite limited, but the organization’s long-awaited drug pricing system revision is in process.

 

The organization sees it as a positive change as RSA scope expansion and PE-exemption system amendment are all part of regulatory reform to improve patient’s access to new drug.

 

We fully understand the government’s contemplation on soaring medical expense.

 

However, considering on how ‘Korea Passing’ phenomenon was a prevalent issue throughout the pharmaceutical industry, decision on new drug reimbursement has reached a difficult point in time as it has to take account of other countries as well.

 

We have a great anticipation on the government’s decision to expand scope of RSA as it was their solution balancing between stable National Health Insurance (NHI) finance and patient’s access to new drug.

 

And also it could be a starting point of regulatory reform to adopt fast-track listing.

 

Although the government has not unveiled any specifics, yet, the organization plans to cooperate with the government to deliver the complete effect of regulatory change to the patients.

 

-Last year, the government presented a research outcome on new drug review period.

 

What do you suggest is needed to enhance the review system?

 

The last year’s research holds a significant meaning to it as it investigated, for the first time in Korea, the actual time taken for new drugs to be reviewed and approved in Korea.” The average time taken for review and approval on 115 investigational new drugs in Korea was approximately 300 days, similar to that in other advanced countries.

 

Unlike other countries with already set predictability of the review system, however, Korea’s approval period showed large gaps between different items and in different years.

 

Predictability is a crucial factor for a business, therefore, the government should consider including additional supplementary material submission period as part of the review processing period to raise regulatory predictability like the other countries.

 

And for rare disease treatment with urgent and highly unmet medical need, the government should activate preferential review system, differentiated from general approval procedure and implement practical policies for better effectiveness.

 

- Regarding regulations, in which part does KRPIA try to improve or recommend?

 

To enhance Korea’s medical and bio companies’ capacity and support their global market expansion, KRPIA has been operating ‘Global Pharmaceutical Company-Startup Co-incubating Platform’ with KOTRA since March 2018, targeting about 100 medical and bio startups.

 

And in 2019, we have organized ‘Global Open Innovation Korea’ with KOTRA, Ministry of SMEs and Startups and Korea Institute of Startups & Entrepreneurship Development (KISED) as an effort to meet the government’s biohealth industry fostering policy.

 

We highly appreciate the government's commitment designating the biohealth industry as one of top key emerging industries and also their aggressive investment on the industry.

 

Nevertheless, it is unfortunate to see multiple government bodies executing different biohealth industry fostering policies resulting in overlapped actions and inefficient communication in between the policies.

 

Based on other cases in overseas, the massive scale of government’s investment, determined to assertively support the bio industry, is as important, but also we believe focusing investment efficiently among various government policies would bring a success to the policy.

 

As Korea already has an outstanding infrastructure in basic science, life science and clinical study for development of biohealth industry, it would be wise to fine tune policies between government bodies to maximize the investment effect.

 

–How about a word of determination and ambition for the New Year’s?

 

For the year 2020, KRPIA plans to provide even more concrete basis for new drug to strengthen ‘patient-centered healthcare policy’, and to raise awareness of social value in new drug.

 

Also, the organization would engage with government and healthcare sector interest groups better to improve existing policies.

 

And we would endeavor to grow deeper mutual relationship between Korean and global pharmaceutical companies in various fields like technology co-development and overseas market co-marketing.

 

Last but not least, the organization would fully support Korea to become a pharmaceutical powerhouse by hosting more clinical trials and increasing R&D investment.

 

We hope the pharmaceutical industry could bring better health to the people and result in fruitful outcome to contribute improving the people’s happiness.