药品知识产权规定在欧盟自由贸易协定中的影响
研究所报告
2021年11月12日

报告摘要

Global trade is increasingly composed of free trade agreements (FTAs) between large trading blocs as well as between smaller, non-aligned countries. These involve tariff-free or -reduced trade in desirable products balanced with concessions for other products or policy changes. The larger, more developed trading blocs like the U.S. or EU also include novel intellectual property provisions in their FTAs with partner countries. On the surface, longer periods of IP protection might be expected to drive up drug costs and would warrant a trade-off in concessions from another industrial sector. This assumption has been debated by researchers and stakeholders and deserves further study.

This report examines the impact of past EU FTAs on drug spending, timing of countries’ access to new medicines after global launch, investments overall and in pharmaceuticals, and clinical trial participation. These are all areas with both economic and societal importance, as well as perceived value to be traded during FTA negotiations. Past studies have studied the impact on U.S. FTAs, and this study brings important new evidence relating to EU FTAs at both a macro and a detailed level.

关键发现

  • The pharmaceutical sector is the most R&D intensive industry in the world, with R&D spending averaging over 15% of revenue compared to other sectors that are often only in the low single digits.
  • 欧盟FTA的强大知识产权规定对欧盟及其FTA合作伙伴国家的行业投资产生了积极影响。
  • While expanded IP protections could in theory generate higher drug spending, past EU free trade agreements (FTAs) that included pharmaceutical IP protection have shown that drugs’ share of healthcare spending tends to stay flat or fall after an FTA, and that prices for medicines rise more slowly than the level of inflation.
  • 强大的IP指数与一个国家的临床试验活动增加有关,这可以带来临床和经济利益。

其他关键发现

  • 对于欧盟FTA,目前的分析表明,与2018年相比,药物支出的平均水平下降了12.8%,当时它们从13.3%降至11.6%。这种药物支出下降适用于中等和高收入国家。
  • This type of analysis was also carried out by NDP Analytics for U.S. FTA partners, with the finding of an average reduction of 3.8% across the 16 countries between the year prior to an FTA with the U.S. and 2018.
  • 对于大多数国家而言,药品的价格通胀小于或类似于(差异不足15%),该市场中所有商品价格的上涨。对于在研究期间实施欧盟FTA的国家,这更为明显。
  • 与每个国家的消费者价格指数的复合年增长率相比药物与欧盟FTA相关。
  • Alternatively, stronger IP protections for some products may have been offset by greater price control effects on others. Therefore, despite variable factors in the pharmaceutical market — such as the introduction of new products or the implementation of IP protection measures — health agencies have sufficient tools to control domestic pharmaceutical expenditure, irrespective of the specific IP provisions of an FTA with the EU.
  • The stronger the RDP and PTR provisions in EU FTAs, the larger the growth in clinical research activities after the FTA is (provisionally) applied.
  • RDP和PTR规定的结合对临床研究的影响最大。这表明,要使欧盟FTA为研发和临床研究做出有意义的贡献,对患者和医疗保健系统的相关收益相关,他们需要同时包括RDP和PTR规定。必威手机APP
谈判的FTA规定在未来几十年中对合作伙伴国家的经济和社会产生重大影响。过去协议的证据为欧盟与澳大利亚和新西兰等合作伙伴之间的持续谈判提出了重要的考虑。基于这项研究,利益相关者有多个考虑因素:
  • 在开发,监管和报销谈判过程(10多年)期间消耗了大量专利寿命,可以通过专利期限恢复(PTR)和监管数据保护(RDP)来降低专利的寿命,并可以将原本缩短的专利寿命延长到平均水平40个月。
  • Stronger IP provisions in EU FTAs have a marked positive effect on investments for all sectors in the EU and its FTA country partners. Total bilateral FDI levels are 10.1% higher when all three IP elements (i.e., IP chapter, RDP, and PTR) are included, adding €6.9 billion in inward FDI, and €10.2 billion per year in outward FDI for the EU each year.
  • 欧盟FTA中的RDP和PTR规定较强,一旦FTA生效,临床试验研究就会显着增加:五年的PTR对应于80%的临床试验,而RDP的(6+2)年相关至70%。临床试验。
  • The drug share of total healthcare expenditures dropped by 3% from 13.2% to 12.8% from 2010 to 2018 in the sub-set of countries that have FTAs with the EU.
  • There is a positive correlation between strength of the IP protection (e.g., the period of exclusivity) and its impact on the access to innovative products (e.g., time from the patent filing to first sales in each market), engendering a faster availability of novel medicines for patients.
  • 在2003 - 2019年期间,与FTA之前的五年期相比,在欧盟FTA签署了具有实质性IP规定的欧盟FTA签署后的五年期间,制药投资急剧上升,如FDI市场基于数据的分析所示on the pharmaceutical sector’s greenfield investments.
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