Russian rules on local trials blow for drug sector and boon for unethical CROs
The organisation made the comments in a quarterly report published last week that criticised the Russian Government for missing its self-imposed deadline to amend the regulations.
“By September 1, 2011, the Russian government was supposed to draft a proposal to cancel local registration trials initially proposed by President Dmitry Medvedev on June 2, 2011 following the 24th session of the Commission for Modernisation and Technical Advancement of the Economy.
“However, not a single amendment has been drafted yet that would give pharmaceutical market participants hope for change in the foreseeable future.”
Ethical, cost and quality concerns
In the report ACTO argues the requirement for Russian registration trials – which was introduced in late 2010 – is "the most serious blow to the system governing the access of new medicines to the Russian pharmaceutical market over its entire recent history.”
Chief among its concerns is that such trials, which often repeat research conducted elsewhere, are unethical under the World Medical Association's Helsinki declaration, which states that: "Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects."
In addition, ACTO argues that local trials drive up the cost of clinical studies - citing claims from unnamed market participants that the average price of a bioequivalence study in Russia has increased from RUB500,000 to RUB1.5m since the requirement was introduced.
ACTO also suggests that growing demand for local studies from Russian and International sponsors “has brought to life a number of service companies that specialise in these types of trials, but unfortunately, are not encumbered with high moral standards and professionalism.”
It is particularly critical of contract research organisations (CROs) that run promotional events and promise potential customers free trial approval from the Ministry of Healthcare and Social Development, arguing that: “Bona fide CROs which value their reputation prefer to avoid such trials.”
Demand increasing?
The contention that demand for local registrational trials in Russia is increasing seems at odds with recently reported data indicating that the level of such activity is lower than it was before the rule was introduced.
However, according to ACTO, the decline seen in Q3 is more of a lag reflecting the complexity of the rules governing trials in Russia and the additional demands that conducting such mandated research places on sponsors.
“[Sponsor] companies need time to make a decision about conducting a clinical trial, prepare the necessary documents and obtain an approval…applicants often do not understand what design can satisfy the regulator, how many patients should be included in the trial to make sure that the results are accepted for registration."
