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Biologicals ban could halt the rush on Russia for clinical trials
Just as the clinical trials sector in Russia is starting to take off, the industry has been dealt a severe blow with the sudden and indefinite banning of biological sample exports.
The move, possibly stemming from Russia's 'mistrust of the West', is for the moment at least, seriously hampering medical research in Russia by blocking hundreds of clinical trial and other research samples from being sent abroad for vital analysis.
Last week, the Russian Federal Customs Service (FTS) without warning shut down the export from the country of all human medical biological materials, including blood and human tissue.
Although Russia's Health Ministry has said publicly that the ban concerned only major shipments of these samples, reports from those on the ground indicate that all biologic samples are being denied exit from the country or severely delayed by days, which still creates potentially damaging consequences over storage quality control.
Either way, information is still scarce and there is much confusion surrounding the decision.
"We still have no information from the Russian government as to what is going on. I have no idea why they have done this," a spokesperson from Russian contract research organisation (CRO) Synergy Research Group told Outsourcing-Pharma.com.
According to a report in Russian newspaper Kommersant, the move was prompted by a report given to President Vladimir Putin by the Russian Federal Security Service (FSB) that focuses on bioterrorism that laid suspicion on the West of using biologic materials shipped from Russia to allegedly develop genetically engineered biological weapons. However, this claim is unconfirmed by Russian officials - Kommersant said that no one from either the FTS or the Russian Ministry of Health was able to explain the precise reasons behind the ban. Meanwhile, other alleged theories for reasons behind the decision have also been flying around, including that this move is a deliberate attempt to sabotage Russia's burgeoning clinical trials industry, in which anywhere from 30,000 to 80,000 Russian patients are thought to be currently involved.
Just after the ban kicked off, Kommersant questioned President Putin over the issue during an international press conference last Friday and he was quoted as saying: "It is hard for me to say exactly because I do not know very much about this. I think that rules should be drawn up, and the Health Ministry should take part in this work".
He also expressed his doubts as to whether anyone has been specifically helped through these biological samples being sent abroad.
"But one should be working with the Health Ministry on all of this. All countries have rules on issues such as organs, tissues and so on being taken out of the country. This is a sensitive issue and any civilised country should have some rules in this area, Russia too. I do not know all the details of this issue, but rules will be put in place and we will all work within their framework", he added.
When asked by Kommersant whether the borders could be opened again while the rules are being drafted, or whether previous rules could be reinstated in the interim, Putin answered: "There are no previous rules. If there had been a set of rules, it would be possible to say whether or not violations have taken place, but there simply was no previous set of rules. Now we need to take steps to bring order to this situation and the Health Ministry's specialists need to get involved in this work and set out their position".
Since then, and in response to the unsurprising uproar from the Russian medical and research community (and beyond), the country's Health Minister Mikhail Zurabov said on Tuesday that the ministry and the Customs Service within the next few days would put procedures in place to allow special permission for biological materials related to the treatment of specific patients to leave the country, said Russian news reports.
However, the agency, for the time being, is retaining its hard line stance on biologic exports that are linked to clinical trials: "Here we can make a pause for a fortnight or so to develop a solution that suits everybody", Zurabov said.
This is concerning because most of the the specimens collected from trials in Russia need to be analysed outside the country in a time-sensitive manner by laboratories that have the required equipment and expertise - nearly 800 transportations of such biological specimens were conducted last year.
Meanwhile, the Russian Federal Agency for Health Care and Social Development (Roszdravnadzor), reportedly told Kommersant that it could not say how long the ban on the export of biological materials will remain in force, but one possible outcome could be that the FTS may order that the number of patients participating in such studies be slashed. "They could tell us to impose restrictions - for example, no more than ten people - and we would do that", said the spokesperson.
Whether it is resolved in a timely or satisfactory manner or not, this whole incident has stuck the knife into Russia's promising clinical trials industry, just as it is beginning to show progress after lying virtually dormant for years.
Although still in its infancy, it is already estimated to be worth between $100m (?74m) and $150m annually and has seen a 40 per cent jump in clinical trial approvals in the last year - evidence of the new rush to conduct trials in this vast and untapped country.
This trial growth assessed based data gathered from Roszdravnadzor on the number of clinical trials it approved during the period and was heralded by Synergy Research Group as part of its latest analytical report on the market of clinical trials in Russia, which it updates regularly.
However, according to the Synergy Research spokesperson, this is just the start of the growth that Russia is capable of: "The market is still emerging and there is still tremendous room for growth." Put into perspective, 600 trials are currently running in Russia, compared to 18,000 in the US, the spokesperson said.
Meanwhile, Russia came third in a resent poll of the most attractive low-cost global locations to run clinical trials outside the US according to analysis conducted by consulting firm AT Kearney, beaten only by Russia and China.
The attractiveness of Russia lies in its low-cost nature (up to half the cost of in the West) and its large and available patient pool, many of whom are treatment-naïve, said the report. In addition, the Russian hospital system treats all patients who have similar symptoms on the same ward, further assisting the recruitment process, which is arguably the single most critical hurdle for a successful clinical trial, and said to be between two and ten times faster in Russia than in the West.
As a result trials from the US alone have tripled here in the past three years and both the European Agency for the Evaluation of Medicinal Products (EMEA) and the US Food and Drug Administration (FDA) are now approving drugs with trial data from Russian sites.
Therefore, drug companies and CROs of all sizes that have ties to Russia stand to lose if the biologic ban situation continues or is resolved with major restrictions in place.
Asterand, a CRO specialising in the supply of human tissue for research purposes, is one example. The company, which sources a "significant" portion of its tissue supplies from donors in Russia, has said that the new biologicals export ban could impact its supply of human tissues, and should the restrictions remain in place for the foreseeable future there would be a "material impact" on the company's revenues.
As a countermeasure, the firm said it is now trying to establish alternative donor sites outside the country as it waits for the situation in Russia to unfold.
"Any company sourcing supplies from Russia is vulnerable to this kind of sudden change in regulations", Martyn Coombs, Asterand's new CEO said.
Indeed, other large international drug firms such as GlaxoSmithKline, Bristol-Myers Squibb (BMS), along with the big CROs Quintiles, PRA International, Kendle, Parexel, Charles River Laboratories, PharmaNet and INC Research have all taken the plunge and set up operations there and were asked by Outsourcing-Pharma.com to comment on how they are currently being affected, all failed to do so by the time of publishing, except for BMS who said: "No comment."
Even if the situation is remedied in the near future, this incident has been potentially damaging to Russia's reputation in the medical field as a place to conduct business.
"It's a scandal and is doing nothing to help build the trust that is already lacking in the Russian clinical trials market," said the Synergy Research spokesperson.
"The formation of a civilised market of clinical trials in Russia and improvement of the research attractiveness of Russia for foreign sponsors as well as exoneration of clinical trials in the eyes of Russian public are the key strategic objectives of Synergy Research Group."