Youngshin Lee, CEO of KRPIA, has built a career spanning more than three decades across pharmaceutical R&D, industry, and policy, advocating for collaboration between regulators, industry, and patients. Under her leadership, KRPIA has become a key voice in shaping Korea's transition toward an innovation-driven biopharma ecosystem. Lee discusses landmark pricing reforms, patient access challenges, clinical trial competitiveness, and the growing role of multinational companies in supporting Korea's emergence as a global biopharma hub.
You have had a distinctive career trajectory – from academic medicinal chemistry, through corporate pharma at Bayer, to the DIA, and now leading KRPIA. What has been the guiding principle throughout?
I have been in the pharma industry for over 30 years. I started my career as a researcher in new drug development, then shifted into industry and spent about a decade at Bayer, then moved into a different sector before joining the DIA. DIA is focused on clinical trials, but more broadly it sits at the intersection of regulators, pharma, and patients. Working there, I became one of the people who witnessed what happens when those groups genuinely work together and make things better. That experience shaped me.
My personal mission has always been to go together – to find roles where I believe I can make a meaningful contribution to the organisation and to the broader purpose.
I had promised my husband I would retire at a certain age in a certain month. I broke that promise when I joined KRPIA. The past seven years have been a gift – problem solving and policy shaping, watching access improve, and witnessing Korea announce that it intends to transform from a generic-centred industry to one that values and rewards innovation.
For readers not familiar with KRPIA, could you describe the association, its membership, and how it operates?
We have 51 members as of today. The one qualification to apply for membership is that a company must have a new drug pipeline close to launching globally – that is the threshold. No domestic Korean pharma company has yet met that qualification, though I am certain that day is coming. So currently our members are entirely multinational companies – a good mix of US, European, one Chinese-based, Japanese, and Australian companies.
We operate with 17 employees, including myself – a small group of staff to represent 51 global companies. But it works because our members generously donate their time and expertise. The model I’ve put in place is built on shared objectives rather than differences. If you focus on differences, you cannot reach common ground. If you concentrate on shared goals, collaboration and a unified voice follow naturally.
The structural expression of that philosophy is an annual resetting meeting every October, where I invite all general managers to agree on the goals for the following year against our five-year roadmap. We present what we accomplished in the previous year, where we are on the roadmap, and where we are going. Once everybody has agreed, those become our goals – not KRPIA’s goals, but our goals. We have seven committees that report to me, including a steering committee for strategy and task force teams that prepare position papers, collect member input, and develop the unified positions we use in every government meeting, every national assembly interaction, every academic engagement. The same message, every time.
Being KRPIA’s first female CEO is meaningful to me, but I believe the bigger story is how Korea’s healthcare ecosystem is evolving. Today, progress depends on different stakeholders working together toward common goals. That is the story worth telling.
Your four strategic priorities for the association – can you walk us through them?
The first and always the highest priority is patient access – which includes the value of innovation, in other words rewarding innovation appropriately, and policy shaping. Our policy committee works in close coordination with our market access committee on this. Patient access work primarily involves engaging with the Ministry of Health and Welfare and its affiliates: HIRA, the National Health Insurance Service, and NHIS, the National Health Insurance Service.
The second priority is regulatory standards, where we work with the MFDS – the Korean FDA. Here our focus is on global harmonisation: IND/NDA requirements, approval timelines, and making sure Korea’s regulatory standards are aligned with international norms. I can say with confidence that we have become a genuinely good partner with the MFDS. We exchange views, we discuss direction together, we serve as a source of international data and best practice. The relationship with the Ministry of Health and Welfare is still developing toward that same quality of true partnership, but we are working on it.
The third and fourth priorities are business compliance and the reputation of the global pharmaceutical industry. On compliance, we have been an industry leader in Korea for many years, and we are committed to maintaining that leadership. We also aim to strengthen the reputation of the global pharmaceutical industry by engaging more actively with the media and the broader public, helping to build a better understanding of the value of innovation and patient access.
2026 has the feel of a breakthrough year for pharma policy in Korea. The drug pricing reform announced in November 2025 is the most significant in a generation. Can you explain what has changed and why?
When the Ministry of Health and Welfare announced the pricing reform on November 28, 2025, they explained three background rationales, and I think those three rationales tell the story of why this moment arrived.
The first is limited access to innovative and essential medicines. Korea’s listing delay after approval is significant. According to PhRMA data from 2023, the average listing delay in Korea is approximately 18 months, compared with three months in Japan and 15 months in France. Only 33 percent of globally approved innovative medicines have been approved in Korea, and only 22 percent are reimbursed. Only five percent of new medicines are launched in Korea within one year of their global launch. The average time to reimbursement-based access for Korean patients is approximately four years. The COVID-19 pandemic also exposed supply chain vulnerabilities that sharpened the government’s awareness of what it means to have constrained access to essential medicines.
The second background is the generic-centred market structure. Korea’s generic prices are 2.17 times the OECD average, according to PMPRB 2022 data. At the same time, Korea’s R&D-to-sales ratio stands at 8.4 percent, compared with 21.4 percent for PhRMA member companies. Innovative drug prices in Korea are among the lowest in OECD countries – below comparable economies like Japan, France, and the United Kingdom. The market structure has simply not rewarded innovation.
The third background is the rapid growth in drug expenditure. Drug spending in Korea increased 62 percent between 2017 and 2024, with an average annual growth rate among seniors over 65 of 9.1 percent. The government wanted to address that trajectory, and recognised that lowering generic prices could release funds to support better access to innovative drugs.
So the direction they have set is a genuine pivot: lower generic and original drug prices, use those savings to fund improved access to innovative medicines, and provide carrots for domestic companies to invest in R&D through IPC, the Innovative Pharma-company Certification scheme. The direction is welcome. The details are still being worked through.
The reform includes specific mechanisms – the 100 Day Rule, flexible pricing contracts, indication-based pricing. Can you explain what these mean in practice and when they take effect?
The 100 Day Rule is a fast-track listing mechanism starting with rare diseases, and it is already in pilot. The proposed implementation timeline is 2027 to 2028, with 2027 being the target on their roadmap. The broader reform roadmap runs in phases: the first half of 2026 focuses on enhancing access to rare disease treatments and introducing flexible drug pricing contracts; the second half of 2026 brings enhanced preferential treatment for IPC-certified companies and pricing calculation standard reforms; 2027 introduces ICER improvement, post-listing management special provisions, and adjustment of already-listed drugs; from 2028 onward, the system moves toward full restructuring of the evaluation system, market-linked actual transaction prices, and the establishment of periodic evaluation and adjustment mechanisms.
The ICER flexibility and indication-based pricing are also part of the package – tools that allow the rigid current framework to be applied more selectively and appropriately to different situations.
How are you preparing members for the practical challenges of these new mechanisms – real-world evidence requirements, outcome-based risk-sharing?
The government is already working with HIRA and NHIS for flexible pricing, and an academic institution to study the best model for prior access with post-evaluation. They have commissioned studies, and one study is currently recruiting a principal investigator to lead a six to 12-month analysis of international best practice before they finalise the implementation design. We welcome that rigour.
On outcome-based risk-sharing agreements specifically – which are becoming increasingly important for next-generation cell and gene therapies and other high-cost innovative treatments – our view is that innovation works better when risk is shared. Cell and gene therapies often target rare or severe diseases and may provide long-term benefits from a single or limited number of treatments. By linking reimbursement to real-world outcomes, these agreements can help patients access innovative therapies while supporting the sustainability of the healthcare system. As these models evolve in Korea, we will be advocating for predictable and reasonable post-evaluation mechanisms, and continued dialogue between government and industry to ensure patients have timely and stable access.
On the industry side, we have task force teams that are collecting data, preparing our position, and engaging in round table discussions with the government – sometimes with academia in the room, sometimes just government and industry associations. The three main industry associations – KPBMA for domestic companies, ourselves for MNCs, and KOBIA for biologics – all participate in these discussions and provide unified or coordinated input. The government then synthesises that against other stakeholder perspectives. It is a deliberative process, and it takes time.
Korea is currently fourth from the bottom in OECD countries for combined approval and reimbursement timelines. What is behind that ranking?
The approval lag is the more significant issue. Korea’s innovative drug prices are so low relative to comparator countries that pharmaceutical companies will often wait until they have launched in other major markets before submitting for approval in Korea. The pricing and reimbursement environment has historically not made Korea an attractive early-launch destination. The approval lag reflected in the statistics is therefore, in part, a consequence of the pricing and reimbursement system that the current reforms are intended to address.
There is also a data integrity issue with the published timelines. The official figures count only legal working days from submission to approval, not the actual calendar time from the moment a company decides to engage with the Korean process. Our own data shows that the actual average time is more than double the published figure. Patients in severe disease categories and rare disease categories wait considerably longer than the statistics suggest. They know the medicine exists, it is coming, but it is too expensive to buy out of pocket, and the national insurance system has not yet listed it. That situation is exactly what the reform is designed to address.
Turning to clinical trials – Korea has a well-deserved international reputation as a premier clinical trial destination, but there are signs of pressure. What does the data tell you?
Korea combines speed, quality, and trust, and that combination has served the country well. We have a strong healthcare infrastructure, highly experienced investigators, and world-class clinical trial centres where clinical practice and research and development sit side by side. The concentration of patients at the major Seoul tertiary hospitals means patient recruitment is very fast, which is a meaningful competitive advantage for sponsors.
Research conducted across Korea-based affiliates of 33 member companies in 2024 found that Korea accounted for 3.46 percent of global clinical trial share, ranking sixth worldwide – a slight drop from fourth in 2023. For multinational clinical trials specifically, Korea ranked 11th. Total clinical trial expenditure by the 33 member companies reached KRW 1,036.9 billion, an increase of 18.8 percent over the previous year. Of that total, KRW 445.2 billion – nearly 43 percent – represented the cost of investigational medicines provided free of charge to domestic patients participating in clinical trials. The total number of trials was 1,691, down approximately 1.9 percent in number, but the number of subjects enrolled in phase I, II, and III trials reached 22,696, an increase of 10.3 percent, with phase III subjects up 17 percent year on year. Oncology-related trials accounted for 69.4 percent of the total, with a five-year compound annual growth rate of 5.7 percent; rare disease trials accounted for 13.1 percent, with a five-year CAGR of 10.1 percent. There were 103 cases utilising real-world evidence in 2024. R&D personnel at the 33 member companies totalled 2,470, up 7.4 percent, with a five-year CAGR of 7.6 percent.
The number of trials is slightly down, but the expense is significantly up. That tells me the trials are becoming more complex and sophisticated – biologics, advanced therapies, late-stage confirmatory studies. That is not a negative signal for Korea as a clinical destination. It is a signal that Korea is being selected for the most demanding work.
The signal that genuinely concerned the government last year was that Seoul dropped from first to second in global city rankings for clinical trial activity, with Beijing taking the top position. When they came to us to understand what was happening, our survey showed no overall downsizing. What we are seeing is that domestic Korean company trials are declining here while China is seeing large increases in both domestic and foreign trials. China has more biotech companies, more funding availability, and more companies actively pursuing global blockbusters. Korea, with some notable exceptions, has been slower to make that transition. Funding availability for Korean domestic companies has been particularly difficult. But I am still optimistic about the clinical trial opportunity here, especially as the complexity of new modalities increases and Korea’s tertiary hospitals accumulate exactly the kind of experience that cell and gene therapy, biologics, and precision medicine trials require.
Korea has become increasingly visible as a deal-making hub. How is the relationship between MNCs and Korean biotech evolving, and is Korea changing its position in Asia?
Korea cannot compete with China in terms of market scale or volume of deal activity. That has to be acknowledged clearly.
But Korea is not, and has never really been, only a supply market. It has become a genuine collaborator, and the traffic is now moving in both directions. In the first half of this year alone, Roche, Lilly, and MSD announced investment and open innovation MOUs with the Ministry of Health and Welfare. That was a direct and positive response to the pricing reform announcement – companies watching whether the government will hold its direction, while also signalling their commitment to this market. Beyond those MOUs, the scale of MNC engagement in Korea’s innovation ecosystem is substantial: our member companies invested over KRW 13 trillion in Korean companies over the four years from 2020 to 2023, across joint research, technology transfer, early-stage clinical studies, and material agreements. They generate more than KRW four trillion annually in economic value through contract manufacturing agreements and partnerships with companies like Samsung Biologics and SK Bioscience. Specific recent examples include MSD’s exclusive platform-technology licensing agreement with Alteogen in 2024 to develop a subcutaneous formulation of Pembrolizumab (commercially known as Keytruda).; Johnson and Johnson licensing LCB84, the ADC candidate from LigaChem Biosciences, in 2023; Merck beginning construction of a KRW 430 billion bioprocess facility in Daejeon to support biopharma manufacturing across Korea and the Asia-Pacific region; and Amgen and BMS running open innovation programmes with KHIDI and the Seoul city government respectively.
What I find genuinely encouraging is that it used to be a one-way flow – technology transfer and open innovation going from MNCs to Korean domestic companies. Now Korean biotechs are building their own platform technologies and licensing them out to MNCs. HanMi, LigaChem – these are examples of Korean companies that have built platforms and done deals on their own terms. The traffic is genuinely becoming bidirectional.
Korea’s speed culture – what we sometimes call “ppalli ppalli” – is a competitive asset in this context. When you harness that speed in the right direction and with solid scientific foundations, it accelerates everything. The CMO and CDMO sector, led by Samsung Biologics, was the first proof of that. It is accumulating knowledge and capability that creates the foundation for the next stage.
I sometimes think about Korea’s industrial history. Every major sector Korea has led globally – electronics, shipbuilding, automobiles – started slowly and then moved very fast once it found its footing. Biopharma can follow the same pattern. But it requires policy to function as a lighthouse. The pricing reform announcement is that lighthouse. My strong message to the government is: do not dilute it. Do not compromise the concept of innovation to comfort other stakeholders. Korea has a genuine opportunity to become a leader in biopharma, perhaps in Asia, perhaps more broadly. If the policy direction holds, I believe this is possible. If it is diluted, that opportunity will not come again.
What legacy do you want to leave behind at KRPIA?
Three things. The first is a way of thinking. I want people in this organisation to keep asking why – not how, but why. Why are we doing this? Why is this the right approach for Korea and for global patients? That question, asked consistently, prevents you from drifting into bureaucratic motion and keeps you connected to the real purpose, which is making patients’ lives different, helping them return to their families and their work.
The second is to be systematic and logical problem solvers. Policy shaping starts from genuinely understanding each other’s differences. There are negotiations, there are disagreements, but you have to find the ground where each party is partly satisfied and partly not. There is no single perfect solution in policy. But if you do not give up, you get there. The last seven years have taught me that. Progress feels slow in the moment, but it is moving.
The third is the system itself. A system that outlasts any individual, that operates on clear shared principles, that our members understand and trust, and that the government knows it can engage with as a reliable and constructive partner. That system is what KRPIA’s Vision 2030 – Innovation, Patients, and Growing Together – is designed to build. I hope those three things remain in this organisation long after I have kept my promise to my husband and finally retired.
