scholarly journals Trade Agreements and Pharmaceutical Patent Protection: Implications for the Governance over Pharmaceutical Products in Canada

2012 ◽  
Vol 1 (1) ◽  
Author(s):  
Danalyn Byng
Keyword(s):  
Patent Protection ◽  
Trade Agreements ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
Brand Name ◽  
International Trade Agreements ◽  
Pharmaceutical Patent ◽  
Canadian Health ◽  
Brand Name Drugs

This paper was prepared for a course on Canadian health policy. Its purpose is to expose the harmful ramifications of international trade agreements on the pharmaceutical market in Canada and the governance surrounding this market. This paper will explore the various implications that trade agreements have on the affordability of drugs, the strength of intellectual property protection, and the transfer of authority and influence from government to “Big Pharma.” This paper will unravel the reality that trade agreements are not beneficial to the Canadian people looking to access an affordable pharmaceutical market, but rather, act quite contrary to this. Facts will show that trade agreements work to put money into the pockets of large brand-name pharmaceutical companies in the forms of billions of dollars of revenue and profit. This paper will encourage readers to question the feasibility of extending patent legislation for brand-name pharmaceutical products, the increasing role of trade agreements and the pharmaceutical industry in Canada, and the substitutability of brand-name drugs over cheaper generic alternatives.

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

scholarly journals The role of international trade agreements in the economy of developing countries (the case of Nigeria)

2018 ◽  
pp. 5-22
Author(s):  
Henrietta Nagy ◽  
◽  
József Káposzta ◽  
György Neszmélyi ◽  
Omokheka Obozuwa ◽  
...  
Keyword(s):  
Developing Countries ◽  
International Trade ◽  
Trade Agreements ◽  
International Trade Agreements

scholarly journals An Analysis of the Transformation of Mega-Pharma’s Business Model toward the Emerging Market

2020 ◽  
Vol 4 (4) ◽  
pp. 253-262
Author(s):  
Yaeko Mitsumori
Keyword(s):  
Patent Protection ◽  
Business Models ◽  
Emerging Market ◽  
Patent Application ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Indian Market ◽  
Application Data

The Trade-Related Aspects of Intellectual Property Rights（TRIPS) requires all member countries of the World Trade Organization (WTO) to introduce a TRIPS-compatible patent law into their countries. Due to the enforcement of TRIPS in 1995, India in 2005 revised its patent law and enacted the Patents (Amendment) Act, 2005. The 2005 ACT included product patent in pharmaceutical field. Due to the new patent law with product patent protection, large foreign capital pharmaceutical companies one after another re-entered the Indian market and started engaging in both R&D and production targeting the Indian market. However recent data shows the number of patent applications has been declining over the past several years and the number of patented drugs launched in India did not increase so rapidly. This study analyzes transitions of business models of foreign pharmaceutical companies in India based on the patent application data, and the trend of patented drugs in the market. A data analysis and a series of interviews with stakeholders were conducted. As a result of both a quantitative and a qualitative analysis, it was found that foreign pharmaceutical companies changed their strategies in the Indian pharmaceutical market. Since India was required to introduce product patents in the pharmaceutical area, there have been many arguments that once India introduces a product patent, the Indian pharmaceutical industry may decline due to the rapid introduction of foreign pharmaceutical products in the country; many academic papers were published in this context during that time. However, since 2005, when product patents were actually introduced in India, few academic papers were published. This study is unique as it discusses the effects of the introduction of product patents on the Indian pharmaceutical market.

scholarly journals GATS and International Trade in Health Services: Impact and Regulations

2017 ◽  
Vol 3 (2) ◽  
pp. 104
Author(s):  
Bakhouya Driss
Keyword(s):  
International Trade ◽  
Health Services ◽  
Health Sector ◽  
Trade Agreements ◽  
International Trade Agreements ◽  
Foreign Products ◽  
Health Products ◽  
The Impact

This article is interested in studying the impact of trade agreements on the quality of health services, and the statement of the role of the Ministry of Health to protect the quality of these services. The problems that arise in this study; how the application of GATT on trade in health, and services? This article also includes the impact of international trade agreements on the issue of attracting foreign investments in the field of health, and to clarify the government's ability to maintain the health and political, and the capacity of national health products to compete with foreign products. As pointed out repeatedly in this paper, it is too early to make definitive conclusions regarding the impact of GATS, or the liberalization of trade, in the health sector. Nevertheless, we conclude that although so far only a few countries where trade in health services has a major role, trading as it does –which is not based on the GATS or GATS commitments– and appears to be increasing, GATS agreement provides a framework for international trade in services, including health services, but the actual content and obligations are determined in large part by the national government.

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