• The Korean Society of Law and Medicine
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• v.23 no.4
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• pp.3-28
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• 2022

Recently, the targets and clauses of negotiation between 'National Health Insurance Service (NHIS)' and Pharmaceutical companies has been expanded. Due to newly adopted 'Quality management clause', 'Compulsory supply maintenance clause' and 'Penalty for breach of contract clause', not only 'Ministry of Health and Wellfare (MOHW)'s 'drug listing' and 'Price cap' announcement, but also 'negotiation between NHIS and pharmaceutical companies' can be a legal sanction to the suppliers. Once secretary of MOHW order NHIS to negotiate with pharmaceutical company, NHIS notify this order to the company and enter into the negotiation. 'The order' exists in the public domain between the government (MOHW) and public institutions (NHIS) and does not constrain the legal rights of companies (Therefore companies cannot pile a lawsuit about the order). However, 'the notice' or 'negotiation' is an act which has a counterpart, can be a target of administrative litigation if the company get some disadvantages from the talks. Negotiations can be divided into four types according to "the target (whether it is listed on the insurance benefit list)" and "the purpose (whether the target is price or conditional)." In particular, negotiations on listed drugs, whose goal is to set unfavorable conditions for companies, can be illegal if there is no price. So we need to consider compensation for the company as an incentive to negotiate.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.338-344
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• 2011

This study aimed to identify the changes in the list of drugs covered by national health insurance(NHI) after the introduction of positive list system (PLS) in Korea in December, 2006. Six-year (pre-policy:2004-2006, post-policy:2007-2009) lists of the NHI reimbursable drugs filed from Health Insurance Review and Assessment Service (HIRA) were analyzed. The total number of listed drugs as well as drug ingredients, and the average number of listed drugs per manufacturer decreased annually after the introduction of PLS. More than 8,000 drugs were delisted in the year 2007 right after the policy change. Prescription-only drugs occupied more than 85% of NHI listed drugs. The percentage of oral type of listed drugs has been increased to more than 60% after the policy change. Korean pharmaceutical manufacturers occupied more than 90% of listed drugs than multinational firms. The gap between Korean and foreign manufacturer in terms of the average number of newly listed drugs per manufacturer in each year has decreased two years after the PLS (Korean 7.7 vs. foreign 6.3 in 2009) as the price negotiation power of foreign firms has increased. The total number of listed drugs is expected to decrease in the future as the Korean government makes an effort to delist the unnecessary drugs that do not show cost-effectiveness.