Parallel Import in Relation to Patent and Trademark

2016 ◽  
Author(s):  
Kumar Salva Raghuvanshi
Keyword(s):  
Parallel Import

scholarly journals Infectivity Titers of Each Component of the Influenza Virus in the Live Vaccine Purchased from a Parallel Import Distributing System

2015 ◽  
Vol 89 (6) ◽  
pp. 720-726
Author(s):  
Ko SATO ◽  
Yuki KIKUCHI ◽  
Yoshifumi MASAGO ◽  
Suguru OHMIYA ◽  
Hiroko ITO ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Live Vaccine ◽  
Parallel Import

Legal and regulatory update: Voluntary withdrawal of marketing authorisations and consequences for parallel importers

10.5912/jcb46 ◽  
1969 ◽  
Vol 9 (4) ◽  
Author(s):  
John Wilkinson
Keyword(s):  
Public Health ◽  
Marketing Authorisation ◽  
Parallel Import ◽  
Voluntary Withdrawal ◽  
Actual Risk ◽  
Regulatory Update

When a reference marketing authorisation is withdrawn for reasons unconnected with the protection of health, as in cases C-15/01 and C-113/01, it is not acceptable that a parallel import licence granted there under should automatically terminate unless an actual risk to public health can be demonstrated.

scholarly journals TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Pharmaceutics ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 48
Author(s):  
Shiri Mermelstein ◽  
Hilde Stevens
Keyword(s):  
Intellectual Property ◽  
Access To Medicines ◽  
Essential Medicines ◽  
Empirical Literature ◽  
Future Research ◽  
Middle Income ◽  
Compulsory Licensing ◽  
Parallel Import ◽  
Policy Tool ◽  
Trade Offs

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

scholarly journals Global trade and health: an Indonesian perspective on the asean medical device directive policy

2021 ◽  
Vol 37 (1) ◽  
pp. 1
Author(s):  
Nurul Hidayati ◽  
Dedy Almasdy ◽  
Abdi Setya Putra
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Free Trade Area ◽  
Policy Makers ◽  
Compulsory Licensing ◽  
Parallel Import ◽  
Trade Area ◽  
Strategic Issue ◽  
Asean Countries ◽  
Document Review

Purpose: Health care equipment international trade could serve a new strategic revenue for Indonesia. Since its implementation in 2015, AFTA has been a very strategic issue in creating export opportunities for its member countries. One of the sectors that becomes a priority for ASEAN integration is in the field of medical devices which is regulated in the ASEAN Medical Device Directive (AMDD) policy. Indonesia itself has officially ratified AMDD policy since 2018, but Indonesia will have been facing the problem of quality, innovation and diversification of medical devices. This study examines the competitiveness opportunities for domestic medical devices in ASEAN Free Trade Area. Method: This study used a qualitative method where information was obtained from in-depth interviews and document review. The informants came from policy makers, implementing officers, and stakeholders. Results: Indonesia has harmonized 26 out of 31 standards mandated by AMDD. Conformity assessment bodies in Indonesia that have been certified by the National Accreditation Committee have received international recognition. Indonesia has many potential exporting innovative medical devices to ASEAN countries. Fulfillment of medical devices is carried out through compulsory licensing and parallel import mechanism.

Sign in / Sign up

Export Citation Format

Share Document