Access to Essential Medicines and Intellectual Property Aspects: Opportunities for Reform and

OptimizationNational Technical Meeting

2-3 June 2015Kyiv, Ukraine

TRIPS-plus provision and their social cost. FTAs and typical TRIPS-plus clauses. Examples of risk mitigation

Mohammed El Said University of Central Lancashire (UCLAN)

UK

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The global landscape of IP regulation The Flexibilities of the TRIPS Agreement TRIPS-Plus rules Impact of TRIPS-Plus rules on medicines

prices Limiting the impact of TRIPS-Plus rules Concluding remarks

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Topics of discussion

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The global landscape of IP regulation today

The global landscape of IP regulation today

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TRIPS WIPO (treaties) Multilateral (ACTA) Regional and Bilateral

(FTAs, AAs, BITs, TTP, DCFTA…etc)

International UN bodies (WIPO, UNDP, WHO, UNCTAD…etc)

NGOs, civil society, donors, academia….etc

TRIPS flexibilities Transition periods Patentability criteria Compulsory licensing and government use Exceptions and exemptions Parallel importation Enforcement flexibility

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The Flexibilities of the TRIPS Agreement

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FTAs and TRIPS-Plus = IP and Access to

Medicines

New/Expansion of the scope of drug patents & monopolies: lowering patentability standards and Patents available for surgical and treatment methods and Minor variations on old medicines. Biological peoducts

Extend drug monopolies: extending patent term through ‘evergreening’

Permitting patent abuse: by requiring countries to condition marketing approval on patent status (patent linkage)

“data exclusivity” Compulsory licensing and parallel importation

restrictions Prohibit pre-grant oppositions – IP enforcement–grant condition

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Examples of TRIPS-Plus obligations

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

YET….we know some facts on: Indicators about the negative impact of

TRIPS-Plus obligations

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Impact of TRIPS-Plus rules: what we know and what we

don’t…

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Example of the impact of TRIPS-PLUS obligations on access to medicines

Price increase of 9% to 15% in absolute terms over covered active ingredients by 2027 with Data exclusivity (80% of the impact)

If the public budget does not increase, consumption will decrease by 8% in the worst-case scenario.

There will be a reduction of 14% in the public market share and 24% in the private market for local generic industry by 2027.

Source: ICTSD, WHO, UNDP, WBI, and UNCTAD (2008).

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The Dominican Republic Case TRIPS –Plus rules (CAFTA) 2007-

2027

By 2030, the price will increase between 18% and more than 40% yearly for covered active ingredients.

There will be a need for increased public spending from about 2.008 to 3.357 million USD by 2030, depending on the scenario.

If the public budget is not increased, consumption will decrease by 24% in the worst-case scenario.

By 2030, there will be a reduction between 24% to 27% in market share for the local generic industry.

Source: ICTSD, WHO, UNDP, WBI, and UNCTAD (2008).

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Costa Rica Case because of TRIPS –Plus rules (CAFTA) 2008-

2030

EU–Colombia FTA (IFARMA, 2009 and Gamba 2011)

By 2030, patent-term extensions could increase expenditure on medicines in Colombia by nearly $280m;

data-exclusivity rules resulted in an increase of more than $396m (2003-2011).

EU–Peru FTA (IFARMA, 2009) The introduction of data exclusivity & patent extension

would lead to an increase of 459 m USD in Peru’s total pharmaceutical expenditure in 2025

A cumulative increase in expenditure of 1267 million dollars (at present value) for the same year.

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Indicators about the negative impact of TRIPS-Plus

US–Jordan FTA Data exclusivity resulted in significant

delays to the introduction of generic competition for 79% of medicines examined.

This led to price increases of between 2 & 10-fold for key medicines to treat cardiovascular disease and cancer.

The availability of generic equivalents would have reduced Jordan expenditures on medicines by between $6.3m and $22m between mid-2002 and 2006.

Source: Oxfam International (2007)

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Indicators about the negative impact of TRIPS-Plus

US-Thailand FTA A macro-economic model measuring the impact of data exclusivity and patent extension proposals forecasted that all scenarios demonstrated a negative impact on the pharmaceutical market and access to medicines. Medicines‟ prices would increase by 32 percent and the domestic pharmaceutical market would contract of $3.3m by 2027.

Source: (University of Bangkok prospective impact study)

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Indicators about the negative impact of TRIPS-Plus

….Where countries have undertaken TRIPS-plus commitments, all efforts should be made to mitigate the negative impact of these commitments on access to treatment by using to the fullest extent possible, remaining public health related flexibilities available……

UNDP, UNAIDS ISSUE BRIEF | 2012

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So what to do???

Protection will not be granted or continue in cases of:- Anticompetitive behavior;- Public health, national security, non-commercial public use,

national emergency- The pharmaceutical product is subject of a compulsory license;- The product has not been commercialized in Chile within 12

months from the date of registry or sanitary approval in the country;

- The product has a registry or authorization in a foreign country of more than 12 months

Source: Decree 153 (2005) of the Health Ministry, mechanisms for the Protection of Undisclosed Data

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US-Chile FTA: dealing with TRIPS-Plus challenges:

undisclosed information

The extension of the patent term is possible if three conditions are met:

- i) the patent claim contains at least one “pharmaceutical substance per se”;

- ii) that the product is included in the Australian Register of Therapeutic Goods; and

- iii) marketing approval was issued less than five years after the filing of the patent.

-Australian patent law also includes specific procedures for opposition to patent term extension and more limitations on patents during extensions. This allowed the patent office to reject some applications

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US-Australia FTA: measures taken by Australia to limit patent term extensions

India, Section 3 (d) Brazil, prior consent Kenya, Judiciary

Examples of other measures

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Creation of checks and balances IP as one element, IP as a mean

and not end in itself, examples: National public health and innovation

agendas Role of competition law, SA case Patent offices Pension schemes, national health

insurance programs, price controls… Role of Judiciary Access to information laws

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The Strategic Implementation of IPRs under national Law

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Strategic implementation should precede negotiations =

you reap what you sowyou reap what you sow

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Thank you

Mohammed El SaidMel-said@uclan.ac.uk

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