The Impact of Pharmaceutical IP Provisions in EU Free Trade Agreements

Other Key Findings

• For EU FTAs, the current analysis indicates that pharmaceutical expenditures drop from the year before the FTA by 12.8% on average compared to 2018, when they fell from 13.3% to 11.6%. This drop in drug spending applies to both middle- and high-income countries.
• NDP Analytics还针对美国FTA合作伙伴进行了这种类型的分析，发现在美国FTA和2018年FTA之前的16个国家中，平均降低了3.8％。

• 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。
• The compound annual growth rate (CAGR) of the price per standard unit of all prescription medicines (patent protected, generic and others) compared to the CAGR of the Consumer Price Index in each country suggest there are no significant increases in the average unit cost of medicines correlated with EU FTAs.
• 另外，对某些产品的更强大的IP保护可能已被对其他产品的价格控制更大的影响所抵消。因此，尽管药物市场的可变因素（例如引入新产品或IP保护措施的实施），卫生机构具有足够的工具来控制国内药品支出，而与欧盟FTA的特定IP规定有关。必威手机APP

• 欧盟FTA中的RDP和PTR规定越强，FTA（临时）应用后临床研究活动的增长就越大。
• The combination of RDP and PTR provisions together has the strongest impact on clinical research. This suggests that for EU FTAs to make a meaningful contribution to R&D and clinical research, with associated benefits for patients and the healthcare systems, they need to include both RDP and PTR provisions.

• Significant periods of patent life are consumed during the development, regulatory and reimbursement negotiation processes (10+ years) and can be mitigated by patent term restoration (PTR) and regulatory data protection (RDP), which extend an otherwise shortened patent life by an average of 40 months.
• 欧盟FTA中更强大的知识产权规定对欧盟及其FTA国家合作伙伴的所有部门的投资都有明显的积极影响。当包括所有三个IP元素（即IP章，RDP和PTR）时，双边外国直接投资水平均高出10.1％，每年为欧盟增加69亿欧元的外国外国直接投资，每年向外部外国直接投资增加102亿欧元。
• 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。
• 从2010年到2018年，在与欧盟的FTA的国家必威手机APP /地区的子集中，从2010年到2018年，医疗保健总支出的药物份额从13.2％下降到12.8％。
• IP保护的强度（例如，排他性时期）与其对获得创新产品的影响（例如，从专利提交到每个市场的首次销售的时间）之间存在正相关关系患者的药物。
• In the 2003-2019 period, pharmaceutical investments rose sharply in the five-year period following the signing of an EU FTA with substantive IP provisions when compared to the five-year period prior to the FTAs, as illustrated by fDi markets data-based analysis on the pharmaceutical sector’s greenfield investments.