Sagaon-Teyssier Luis, Singh Sauman, Dongmo-Nguimfack Boniface, Moatti Jean-Paul
Aix Marseille Univ, INSERM, IRD, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM), Marseille, France.
ORS PACA, Observatoire régional de la santé Provence-Alpes-Côte d'Azur, Marseille, France;
J Int AIDS Soc. 2016 Oct 19;19(1):20619. doi: 10.7448/IAS.19.1.20619. eCollection 2016.
This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants.
The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement.
ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary.
Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may slow down or even reverse long-term trends towards price decreases.
Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS flexibilities, with a special emphasis on negotiations with generic manufacturers.
本研究旨在通过分析2003年至2015年期间捐赠方资助的抗逆转录病毒药物（ARV）采购交易数据以及ARV价格决定因素，呈现全球抗逆转录病毒药物市场的概况。
数据来自世界卫生组织艾滋病药品和诊断服务处管理的全球价格报告机制（GPRM），包含约占捐赠方资助的成人抗逆转录病毒药物采购交易总量80%的信息。
出厂价和采购量按照年度剂量指南进行标准化。数量和价格的描述性统计显示了抗逆转录病毒药物市场的主要趋势。对整个样本进行普通最小二乘法估计，然后根据供应商类型（原研药和仿制药）进行分层，并控制时间和地理固定效应。鉴于分析是基于GPRM的抗逆转录病毒药物交易价格公共数据集进行的，因此尊重伦理规范，无需获得同意。
在撒哈拉以南非洲地区，原研药平均最便宜，而与此同时，仿制药平均最昂贵。相比之下，在欧洲和中亚，原研药最昂贵，仿制药最便宜。事实上，数据表明抗逆转录病毒药物供应商采取了混合策略，以利用利润最大化机会并适应每个地区的市场竞争特定条件。我们的结果还表明，专利到期不足以推动仿制药竞争的进一步发展（至少在抗逆转录病毒药物市场），仿制药公司之间的正式或非正式协议可能会减缓甚至扭转价格下降的长期趋势。
我们的研究结果有助于更好地理解抗逆转录病毒药物市场，从而帮助各国加强政策措施，提高其在价格谈判中的议价能力以及利用《与贸易有关的知识产权协定》的灵活性，特别强调与仿制药制造商的谈判。
