[Ip-health] Ukraine modifies medicines law--limits data exclusivity protection

Ruth Lopert ruth.lopert at gmail.com
Tue Dec 13 15:31:39 PST 2011

Is this going to lead to undue pressure on the regulatory agency to approve
products before the 2 year mark?

On Tue, Dec 13, 2011 at 5:44 PM, Stephanie Rosenberg <srosenberg at citizen.org
> wrote:

> Ukraine modifies medicines law--limits data exclusivity protection
> Link:
> http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/december_2011/news/ukraine_medicines_law_data_exclusivity
> Ukraine has announced new legislation governing medicinal products that
> effectively limits the data exclusivity protection provided to innovative
> medicines.
> The adoption of Law No. 3998-VI is set to bring data exclusivity
> provisions into line with international standards, and "modifies a previous
> one that is seen as being excessively favourable to innovative producers,"
> according to Brendan Melck, European analyst at IHS Global Insight.
> Ukraine remains a small pharmaceutical market at the moment, but its 46
> million-strong population and increase in consumer spending capacity in
> recent years make it a long-term target for many overseas drugmakers.
> Under the new rules, registration of generics in Ukraine is permitted five
> years after the originator product was registered in in the country.
> Six years of data exclusivity can be however be given to the innovator
> company if - during the first three years of marketing - new indications
> are awarded which are "advantageous" compared to the original indication,
> although the criteria for this have yet to be elaborated by the Ukrainian
> authorities, according to a note from law firm CMS Cameron McKenna.
> More significantly for pharmaceutical companies, however, are provisions
> that state data exclusivity can only be awarded to originator products that
> are registered in Ukraine within two years of initial registration in any
> other country.
> "Although the original amendment to the law is seen as giving too much
> away to innovative producers, the new amendment provides the 'stick' as
> well as the 'carrot'," said Melck.
> "Companies will be forced to consider entering the Ukrainian market
> earlier than they might have planned, if they had planned to enter it at
> all."
> Meanwhile, the new amendment confirms the legal status of compulsory
> licensing of medicines, a measure introduced by Ukraine's government to
> allow import substitution in order to stimulate the growth in domestic
> pharmaceutical manufacturers.
> A recent report from Business Monitor International downplays the impact
> of this development however - at least in the near term - as it believes
> the local industry lacks the capacity and capital to exploit this
> opportunity.
> "For innovative pharmaceutical companies, these are negative, if not
> entirely surprising, developments," commented Melck.
> "Ukraine remains an important market, due to its sheer size and potential,
> although it is set to remain a challenging one for the foreseeable future."
> Stephanie Rosenberg
> Global Access to Medicines Program
> Public Citizen | Protecting Health, Safety and Democracy
> TEL: +1 202-588-7771
> 1600 20th St NW, Washington, DC 20009
> URL: http://www.citizen.org/access
> Twitter: @PCMedsAccess
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