New regulations are needed on the pharmaceuticals market before Russia enters the World Trade Organization, the head of the Association of International Pharmaceutical Manufacturers said Monday.
"The Health and Social Development Ministry needs to develop new regulation in the pharmaceuticals market now. These steps are not being taken, [and] we only have a law on the distribution of medicines, which was adopted without consideration of WTO entry," Vladimir Shipkov told The Moscow Times.
Russia has problems meeting international quality standards for medicine, Shipkov said.
Vladimir Dorofeyev, a scientific adviser to the group, said the problem stems from the dissolution of the government Pharmacopoeia Committee in 2004.
"You never know who is responsible for medicines' quality," Dorofeyev said. "Some of [the committee's] functions went to the Federal Health and Social Development Inspection Service, but we still have no uniform state quality standards."
Industry publication The Pharmaletter noted Sunday that new regulations are slowing the development of clinical trials in Russia. It estimated the clinical trials market in the CIS would be worth 940 euros ($1.25 billion) by 2014.
Nonetheless, "[for the government] the main thing is not the effectiveness and safety of medicines, only budget savings. This is unacceptable," Shipkov said. "We are entering the WTO now, which means equal rights, equal terms and healthy competition among market participants."
Market players will be informed of changes in regulation well in advance after Russia enters the WTO, as is rarely done now, Shipkov added.
A Message from The Moscow Times:
Dear readers,
We are facing unprecedented challenges. Russia's Prosecutor General's Office has designated The Moscow Times as an "undesirable" organization, criminalizing our work and putting our staff at risk of prosecution. This follows our earlier unjust labeling as a "foreign agent."
These actions are direct attempts to silence independent journalism in Russia. The authorities claim our work "discredits the decisions of the Russian leadership." We see things differently: we strive to provide accurate, unbiased reporting on Russia.
We, the journalists of The Moscow Times, refuse to be silenced. But to continue our work, we need your help.
Your support, no matter how small, makes a world of difference. If you can, please support us monthly starting from just $2. It's quick to set up, and every contribution makes a significant impact.
By supporting The Moscow Times, you're defending open, independent journalism in the face of repression. Thank you for standing with us.
Remind me later.