opportunities for reform: the eu fcfta: what to look out for?
TRANSCRIPT
Access to Essential Medicines and Intellectual Property Aspects: Opportunities for Reform and
OptimizationNational Technical Meeting
2-3 June 2015Kyiv, Ukraine
Opportunities for Reform: the EU DCFTA: what to look out for? Opportunities for mitigating provisions
with likely negative public health impact while remaining compliant
Mohammed El Said University of Central Lancashire (UCLAN)
UK
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The EU-Ukraine DCFTA The IP CHAPTER TRIPS-Plus obligations with impact on
access to medicines and public health Mitigating the negative impact of
TRIPS-Plus obligations Conclusions
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Topics of discussion
The Deep and Comprehensive Free Trade Area (DCFTA) signed on 27 June 2014, part of broader Association Agreement (AA).
In April 2014, EU unilaterally granted Ukraine preferential access to the EU market until 31 December 2015.
The DCFTA will offer Ukraine a framework for ‘trade relations and for economic development…creating conditions for aligning key sectors of the Ukrainian economy to EU standards’.
The DCFTA consists of 15 Chapters, 14 annexes and 3 protocols.
Heavy (DEEP) IP chapter (9) included.
The DCFTA
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This chapter includes provisions on particular copyright, designs (including unregistered ones), patents and geographical indications (GIs) , of TRIPS-Plus nature
The chapter has a strong section on enforcement of IPRs based on the EU's internal rules (TRIPS-Plus).
Chapter 9 Intellectual property
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The objectives of this Chapter are to: (a) facilitate the production and
commercialisation of innovative and creative products in the Parties; and
(b) achieve an adequate and effective level of protection and enforcement of intellectual property rights.
Article 157 Objectives
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1. The Parties recognise the importance of the Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 ("Doha Declaration") by WTO. In interpreting and implementing the rights and obligations under this Chapter, the Parties shall ensure consistency with the Doha Declaration.
2. The Parties shall contribute to the implementation of, and shall respect, the Decision of the WTO General Council of 30 August 2003 on paragraph 6 of the Doha Declaration.
Positive impact BUT, IF and …..HOW
Article 219 Patents and public
health
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The Parties shall be free to establish their own regime for exhaustion of intellectual property rights, subject to the provisions of the TRIPS Agreement.
Article 160 Exhaustion
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First: Extension of patent protection (Art. 220). When a medicine is protected by a patent and was
subject to registration procedure, a further period of protection should be provided for up to five years.
In the case of medicines for which paediatric studies have been carried out, and provided that the results of those studies are reflected in the product information, a further six months extension has to be provided.
Impact: extension of monopoly term
Main TRIPS-Plus obligations with impact on access to medicines and
public health
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Second: Data protection and exclusivity (Art. 222) When authorization (registration) of a medicine requires
submission of test data or studies concerning the safety and efficacy of a medicine prior to granting registration, for at least five years from the date of the first approval, it should not be allowed for other applicants to market the same or a similar medicine on the basis of the registration granted to the applicant which had provided the test data or studies without his consent.
Impact: extension of monopoly term and denial of entry of generics
Main TRIPS-Plus obligations with impact on access to medicines and
public health
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Third: Biological products For the purposes of this Agreement: inventions which are
new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
Impact: Further extension of protection to biological products which include vaccines, blood and blood components, and gene therapies in addition to other forms of protection.
Main TRIPS-Plus obligations with impact on access to medicines and
public health
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Fourth: Enforcement (Art. 250) The right of the patent owner to require detention of
suspicious shipments at customs border. The right of customs authorities without the
application of the patent owner to detain suspicious goods.
Timetable: the provisions of the above Regulations should be incorporated into Ukrainian law within three years following the entry into force of the AA.
Impact: affecting entry of generics
Main TRIPS-Plus obligations with impact on access to medicines and
public health
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The Way Forward…..
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Task force and action/implementation plan Incorporate the remaining TRIPS flexibilities
extensively (CL, bolar…etc) Tightening of patentability criteria Prohibition of patenting new forms of known
substances and new uses of known substances; Curtailing data exclusivity Introduction of easy pre-grant and post-grant patent
opposition procedures Introducing limitations on patent extension Enabling parallel imports - international
Way forward…IP regime
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Judiciary Positive Collaborative, Example, coordination
of the decisions on granting patents on medicines with health authorities (e.g., the mechanism of ANVISA in Brazil)
Unfair competition Stakeholder participation The BIGGER PICTURE
Way forward…Beyond the IP regime
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