Opportunities for mitigating provisions with likely negative public health impact while remaining compliant, presented by Mohammed El Said University of Central Lancashire (UCLAN) UK. The presentation covers:
- 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
Unit-IV; Professional Sales Representative (PSR).pptx
Opportunities for Reform: the EU FCFTA: what to look out for?
1. Access to Essential Medicines and Intellectual
Property Aspects: Opportunities for Reform and
Optimization
National Technical Meeting
2-3 June 2015
Kyiv, 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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2. ∗ 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
3. ∗ 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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4. ∗ 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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5. ∗ 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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6. ∗ 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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7. ∗ 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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8. ∗ 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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9. ∗ 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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10. ∗ 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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11. ∗ 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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13. ∗ 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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14. ∗ 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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