Trips plus provisions in eu ftas impact on public health and access to medicines
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TRIPS-Plus Provisions in EU FTAs Impact on Public Health and Access to Medicines. Mohammed El Said (UCLAN) IP and Access to Medicines UNDP, Kiev 22-23 June 2010. Overview. EU and IP protection EU and bilateral trade agreements Some TRIPS-Plus provisions under EU bilateral trade agreements.

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TRIPS-Plus Provisions in EU FTAs Impact on Public Health and Access to Medicines

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Trips plus provisions in eu ftas impact on public health and access to medicines

TRIPS-Plus Provisions in EU FTAsImpact on Public Health and Access to Medicines

Mohammed El Said (UCLAN)

IP and Access to Medicines

UNDP, Kiev 22-23 June 2010


Overview

Overview

  • EU and IP protection

  • EU and bilateral trade agreements

  • Some TRIPS-Plus provisions under EU bilateral trade agreements


Eu and ip

EU and IP

  • Major producer + comparative advantage

  • Main player during the Uruguay Round

  • Industry influence

    Pharmaceutical companies spent US $759 million to influence 1,400 congressional bills between 1998 and 2004; the pharmaceutical industry ranks top in terms of lobbying money and the number of lobbyists employed (3,000).Stiglitz 2006

  • Internal and external policies


Eu and bilateral agreements

EU and Bilateral Agreements

  • Creator of TRIPS-Plus = The Barcelona Process in mid 1990s

  • Understanding TRIPS-Plus.

  • TRIPS-Plus emerge under 3 types of EU bilateral agreements:

    • EU-Association Agreements (AAs)

    • EFTA Agreements

    • EU-Free Trade Agreements (FTAs)


Some trips plus provisions related to public health and access to medicines

Some TRIPS-Plus provisions related to public health and access to medicines

1- Transition periods

2- Extending patent term

3- Data exclusivity

4- Parallel Importation

5- Compulsory Licensing and government use

6- Patentability of new use

7- Patentability criteria

8- Accession to TRIPS-Plus agreements

9- Exceptions and exemptions

10- Terminology issues


1 transition periods

1- Transition Periods

- TRIPS awards transitional periods

  • FTAs may restrict this by applying these standards in advance. e.g EU-Jordan AA

  • Implications

    1- Prevents countries from preparing

    2- Facilitates entry of patented drugs earlier

    3- High royalties


2 extension of patent protection term

2- Extension of patent protection term

  • TRIPS awards 20 years patent protection from the date of filing. (Art 33)

  • FTAs require a country to make available an extension of the patent termto compensate the patent owner for unreasonable curtailment of the patent term. e.g FTAs with Columbia and Peru

  • Implications

    1- Extending patent the term monopoly

    2- Impact on prices and generics

    3- Pressure on patent offices


Patent term extension impact

Patent term extension- Impact

  • A Korean study concluded that the extension of patent term is likely to cost the Korean National Health Insurance Corporation what amounts to US $529m for extending drug patents for 3 yrs and US $757m if it has to agree to a 4 yr extension as proposed under the FTA negotiations with the United States.Hankyore (2006)

  • If provisions in US-AUS FTA delayed by 24 months entry of generics of only top 5 PBS drugs (Aus Reimbursement Scheme), expenditure will increase by 1.5$ billion between 2006-09. Aus Institute


3 data exclusivity requirements

3-DataExclusivityRequirements

  • Separate form of protection from patents

  • TRIPS awards countries considerable policy space

  • TRIPS-Plus introduces this protection form. e.g EFTA-Lebanon provides data protection for least 6 years for pharmaceutical products

  • Implications

    1- Prolonging patent protection term

    2- Delaying generic drugs entry into markets

    3- Higher prices of medicines


Data exclusivity empirical evidence

Data Exclusivity- Empirical evidence

The average price of generic drugs can fall by as much as 30% of the innovator drug price when the number of generic versions of the drug on the market increases(WHO)

  • In Jordan, Data exclusivity, independently prevented generic competition for 79% of medicines launched by 21 multinational pharmaceuticals since 2001.

  • Additional expenditures for medicines with no generic competitor, as a result of enforcement of data exclusivity, were between $6.3m and $22.04mOxfam (2007)

  • 8 years of data exclusivity in Canada would have added 600$m to drug costs alone in the last 5 years. TWN (2008)

  • CAFTA’s Data Exclusivity rules are limiting access to some generic drugs in Guatemala. (Shaffer and Brenner, 2009)


4 parallel importation

4- Parallel Importation

  • Under TRIPS, Countries have discretion to choose the regime (Art 6).

  • Reiterated under Doha Declaration:leave each Member free to establish its own regime for such exhaustion

  • FTAs are imposing restrictions.

  • Implications

    1- preventing countries from benefiting from the variation in pharmaceutical prices

    2- strengthens monopolistic position of companies

    3- higher prices of medicines


Restricting parallel importation impact

Restricting parallel importation- Impact

  • Parallel importation reduced the price of first-line anti-retroviral medicines to one-third of the price of the patented version in Kenya.

    Oxfam (2006)

  • Glivec, an anti–blood-cancer drug, and Norvasc, a hypertension drug –which patent was expired in 2007-. While both drugs were cheaply available in their generic form in India, the drugs were being sold in their patented form in the Philippines with a 90% increase in the price on the Indian market.

  • Oxfam (2006)


5 restricting compulsory licensing and government use

5- Restricting Compulsory Licensing and Government Use

  • TRIPS (Art 31) and the Doha Declaration reiterates members rights

  • FTAs may impose restrictions.

  • Implications

    1- Market monopoly

    2- Negative impact on competition

    3- Diminish flexibilities and options


Compulsory licensing impact studies

Compulsory Licensing- impact studies

  • Malaysia became the first country in Asia to issue a “government use” licence for the importation of generic ARVs in 2003. This reducing the average cost of the Malaysian’s MoH treatment per patient per month from US $315 to US $58, an 81% reduction. Khor

  • If the US-Thailand signed the proposed FTA, compulsory licensing that could have reduced the cost of second-line ARVs by 90% in Thailand would be severely restricted. The WB concludes that issuing compulsory licences for second-line ARVs would represent a saving of US $3.2 billion for the Thai national health budget over 20 years.

    WB

  • Ecuador latest country to issue one for ARVS in 2010. The License immediately reduced cost of drug by 27%


6 patentability of new use

6- Patentability of New Use

  • TRIPS sets the guidelines for granting patents, it contains no obligation to award protection to new use.

  • Increasingly, FTAs are awarding protection to new use, e.g Art 15.9 of US-Oman FTA states:

  • Each party confirms that it shall make patents available for any new uses for, or new methods of using, a known product, including new uses and new methods for the treatment of particular medical conditions.


New use implications

New Use - Implications

  • According to a 2005 survey in France, it found that 68% of the 3096 new products approved in France between 1981 and 2004 brought “nothing new” in comparison to previous preparations. Prescrire (2005)

  • Implications

    1- prolong monopoly and patent term

    2- impacting innovation


7 defining patentability criteria

7- Defining Patentability Criteria

  • Art 27.1 TRIPS protects inventions as long as they are new, involve an inventive step and are capable of industrial application.

  • Some FTAs define these. e.g US-Morocco states:

  • Each Party shall provide that a claimed invention is industrially applicable if it has a specific, substantial, and credible utility.

  • Implications:

    1- Restricting policy space

    2- Imposing standards which may not be suitable


8 accession to trips plus agreements

8- Accession to TRIPS-Plus Agreements

  • TRIPS reference to IP agreements

  • No requirements to join any other agreement outside TRIPS

  • EU-FTAs, e.g EFTA-Morocco, Annex V:

    • PCT

    • Nice

    • Budapest

    • UPOV

    • Rome

  • Other agreements such as the WIPO Treaties

  • Assessment of the impact first is necessary


  • 9 exceptions and exemptions

    9- Exceptions and Exemptions

    • Early working exemption

    • Exceptions from patentability, e.g Art 27.3 of TRIPS gives countries the option to exclude:

      • Diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

      • plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

  • FTAs may forfeit this


  • 10 phraseology terminology

    10- Phraseology/terminology

    • Aim for clarity, avoid use of vague terminologies under FTAs, such as Provision of intellectual property protection in accordance with the “highest international standards” in a “fair and equitable” and ''effective'‘ manner.


    Assessment too soon

    Assessment too soon?

    • According to WHO predictions, the full impact of medicine price rises will not be felt until about 15 years after the FTA begins…

      WHO


    Conclusions recommendations

    Conclusions/recommendations

    • Assessment of impact

    • Collaborative effort

    • Negotiation teams

    • Strengths and weaknesses

    • Checks and balances


    Trips plus provisions in eu ftas impact on public health and access to medicines

    Thank you

    Mohammed El Said

    [email protected]


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