DL Promoting Access to Medical Technologies Flashcards Preview

IIP Law > DL Promoting Access to Medical Technologies > Flashcards

Flashcards in DL Promoting Access to Medical Technologies Deck (26)
Loading flashcards...

What is one element of the fulfilment the right of everyone to the enjoyment of the highest attainable standard of health of the UN Sustainable Development Goals?

Access to essential medicines and health services i


What innovation is differ in medical innovation?

- the ethical dimension of medical research
- a rigorous regulatory framework
- liability questions,
- the high cost of medical research and development (R&D)
- the high risk of failure


What is HIV and AIDS ?

HIV - immunodeficiency virus.

AIDS epidemic - acquired immune deficiency syndrome epidemic.


What initiated a global debate which is still going on today is about?

how to achieve the right to balance between IPR and the right of access to affordable medicines


to how many people helped the price reduction and the availability of more affordable generic antiretroviral treatments ?

in 2015 it helped 15 million people to have access to the treatment


What kind of diseases

tuberculosis (TB)

Need a treatment:
"noncommunicable diseases" (NCDs):
cardiovascular disease, cancer, chronic
respiratory disease and diabetes


What us the name of diseases which affect poor population in poor countries?

neglected diseases


What is the positive aspect of the compulsory licenses?

- countries can to pursue public health objectives
- help build partnerships
- enable innovation through cooperation to bring new medical technologies typically aim at commercial objectives


Conclusion of the Introduction?

in general they are talking about global debate nowadays about access poor countries to the medicine. or the the treatments witch they can not afforded. Neither to buy it nor to produce itself. Global community looking to find a balance between IPR, international trades and the outcome to public health. That is why WHO, WTO and WIPO try to solve this problem together. Introduction also provide as with fact such as how many people it already to saved lives and what kind of benefits actually it can bring to developed countries, patent holders and others.


How policymaking for innovation and access to medical technologies is interlinked in public health IP and trade?

Health policy and other policy domains, such as human rights, development policy, intellectual
property and international trade, interact. Access to medicines and health services is an element of
the right to health and of the United Nations Sustainable Development Goals. Innovation in medical
technologies differs from innovation in others sectors, because of the ethical dimension of medical
research, a rigorous regulatory framework, liability questions, the high cost of medical R&D and the
high risk of failure. Medical technologies are not just another commodity: they need to be widely
accessible and affordable.
The TRIPS Agreement sets international minimum standards for IP systems, but does not and should
not prevent WTO Members from taking measures to protect public health. WTO Members have
recognized the importance of intellectual property protection for the development of medical
technologies and, at the same time have expressed concerns about its effect on prices. WTO
Members.are free to determine the appropriate method of implementation of TRIPS standards within
their own legal practice, national needs and priorities. These policy options are often referred to as
“TRIPS flexibilities”. Countries may implement more extensive protection if they wish, provided it is
International trade allows new technologies to spread around the world, can bring down the cost and
stabilize the supply of medical products. Trade is of fundamental importance to promoting access to
medical technologies and innovation, as no country can hope to be entirely self-sufficient in
manufacturing all the medical products it needs. However, there are a number of trade-related factors
that can also negatively impact access to medical technologies, ranging from import tariffs to the
inclusion of intellectual property provisions in trade agreements that delay the entry of generic
products into the market. The current WTO agreements include a range of policy options or
“flexibilities” that are available to pursue public health objectives in the intellectual property system.


Access to medical technologies ?

- Human rights dimension
- Innovation and public research polices
-International trade and domestic economic settings

- IP law, management and administration
- Regulation: quality, safety and efficacy
- Public health framework


What is the Human Rights Dimension?

The right to health is a central element of the international human rights system as well as of the international health system. e,g the preamble of the WHO Constitution was the first
international instrument to state that "the enjoyment of the highest attainable standard of health is one
of the fundamental rights of every human being without distinction of race, religion, political belief,
economic or social condition".

The poor and vulnerable may be unable to fully realize their right to health due to such
factors as inadequate supplies of essential medicines, high prices and requirements to make out-ofpocket


Outline how the global disease burden will change by 2030.

Under the 3rd goad of SDG the global community commits to end the epidemics of AIDS, TB, malaria and other communicable diseases by 2030., aims to achieve universal health coverage and to provide access to safe and effective medicines and vaccines for all.


What does it mean from Millennium Development Goals to Sustainable Development Goals ?

(MDG >>> SDG)

MDG it was a set of * international development goals that were achieved by 2015. They all were related to improving physical, mental and social well-being for all.

MDG came to an end in 2015, the UN in September 2015 decided on a set of 17 Sustainable Development Goals (SDGs)


What affirmed the WTO Doha declaration on the TRIPS Agreement and Public Health of 2001 (Doha Declaration)?

affirms the right of developing countries to use to the full the provisions in the WTO Agreement on Trade-Related Aspect of Intellectual Property Rights regarding flexibilities to protect public health and, in particular, provide access to medicines for all.


What is the international IP framework?

is primarily defined by the 26 treaties administered by WIPO, as well as the TRIPS Agreement which, noted above, is administered by the WTO. The TRIPS Agreement is a comprehensive agreement that sets international minimum standards for IP protection and enforcement.


What article 27 of the TRIPS states for?

provides that patents must be " available for any inventions, whether products or processes, in all fields of technology. This means that patents must be available for pharmaceutical products (such as a new chemical compound with medicinal effect) and processes (such as a method of producing the medicine)


What special benefits have LDCs ?

LDCs are currently exempt from implementing TRIPS provisions
relating to pharmaceuticals until January 2033 or until they graduate from the LDC status, whichever
is earlier, and can delay implementation of all TRIPS provisions until July 2021.


In what TRIPS agreement specifies?

specifies that WTO Members are free to determine the appropriate method of
implementation of TRIPS standards within their own legal practice. These policy options are often
referred to as “TRIPS flexibilities”. The use of flexibilities is also addressed in the 2007 WIPO
Development Agenda, which aims to address development considerations that form an integral part of
the work of WIPO and the 2008 WHO Strategy and Plan of Action on Public Health, Innovation and
Intellectual Property (GSPA-PHI), which aims to provide a framework for securing an enhanced and sustainable basis for needs-driven, essential health R&D relevant for diseases that disproportionately
affect developing countries.


What is TRIPS - plus?

When considering how to best implement IP laws policy-makers therefore consider international
standards, the practices of other countries and their own national needs and priorities. Countries may
also implement more extensive protection if they wish, provided it is TRIPS-consistent. Such
protection is sometimes referred to as “TRIPS-plus”.

the standards have been established in the IP sections of an increasing number of bilateral and regional trade agreements, as well as in accession agreements to the WTO


What WTO Doha Declaration on the TRIPS Agreement and Public Health of 2001 states ?

recognizes the gravity of the public health problems afflicting many developing countries
and least developed countries and affirms that the TRIPS Agreement does not and should not prevent
Members from taking measures to protect public health. ll WTO Members are free to use the provisions of the TRIPS Agreement in a manner that is
supportive of public health and clarifies certain flexibilities that the TRIPS Agreement provides for this


What is happened in 2003

WTO Members adopted a mechanism to provide additional flexibility in the form of a special compulsory licence for the export of medicines which resulted in 2005 in a corresponding amendment of the TRIPS Agreement.


What is happened in 2016?

In September 2016, the report of the United Nations
Secretary-General’s High-Level Panel on Access to Medicines recommended that WTO Members
should make full use of the policy space available under the TRIPS Agreement.


What states article 8 of TRIPS ?

recognizes the right of
Members to "adopt measures necessary to protect public health and nutrition provided that such
measures are consistent with the provisions of this Agreement".


What is the Trade Dimension?

integration into the world economy can enhance access to the most basic for good health,

supply of food
access to health related products and servics

trade offers for economies to grow and to contribute to alleviation of poverty and ill health. in small countries with no local capacity to produce medical technologies, such imported goods make a uniqe contribution to these countries. national health system.


What is the policy challenges?

there are two issues of access and innovation are intertwined.
it is not enough simply to increase access to existing medicines.

Innovation and access should be seen as two sides of the same coin: information and data about the
changing disease burden causes innovators to set new priorities; new products are developed or old
ones adapted to meet these new needs; and finally, the new products are made available to patients.

However, the basic
challenges are simple:
1. How to mobilise the resources necessary for innovation, including not only capital, but also
scientific know-how, research tools and infrastructure and the regulatory infrastructure?
2. How to effectively deploy these resources to research and develop new technologies to
address unmet health needs?