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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

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 $22.04m Oxfam (2007)
  • 8 years of data exclusivity in Canada would have added 600$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
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