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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The Pharmaceutical Research and Manufacturers of America, along with eight other pharmaceutical, business, and trade organizations, are calling on Russian authorities to consider policy changes concerning clinical-trial regulation and intellectual property.
The Pharmaceutical Research and Manufacturers of America (PhRMA), along with eight other pharmaceutical, business, and trade organizations, are calling on Russian authorities to consider policy changes as they relate to clinical-trial regulation and intellectual property to draft legislation in Russia, the Draft Law on the Circulation of Medicines. The draft legislation is currently under consideration by the Duma, Russia’s legislative body.
“With its strong scientific background and long-term commitment to innovation, Russia is uniquely positioned to become a leader in biopharmaceutical development," said Christopher A. Singer, president of international affairs at PhRMA, in a PhRMA press release. "Right now, Russian legislators have the chance to make key improvements that will improve their investment climate and speed access to innovative medicines for Russian patients."
, PhRMA and eight other associations pointed out that the draft legislation would require applicants to reconduct the full cycle of clinical studies for a drug, regardless of whether clinical trials have already taken place elsewhere. “This provision would not reflect the international trend toward regulatory harmonization and greater transparency,” said the signers of the joint letter. “The Draft Law does not clarify the decision-making process and responsibilities for preregistration [of] clinical trials, and therefore, the duration of clinical trials required in Russia for an applicant may last three to 10 years.”
The signers of the letter also urged that the draft law incorporate language to provide regulatory and data protection that would be in keeping with such protection in the United States and the European Union. “The Draft Law does not provide any regulatory data protection, contrary to Russia’s international obligations to the US and European Union to enact six years of protection into law,” specified the signers in the letter. “Almost all innovative R&D [research and development] worldwide takes place in countries with strong regulatory data protection. Russia needs to implement the six-year standard of protection to be competitive.”
In addition to PhRMA, other signers of the letter included the European Federation of Pharmaceutical Industries and Associations, the US–Russia Business Council, the US Chamber of Commerce, the Mid-Atlantic Russia Business Council, the European–American Business Council, InPharma, the Association of International Pharmaceutical Manufacturers, and the Russian-American Chamber of Commerce.