Novo Nordisk's Quality Control Manager Mikhail Khazanchuk on GDP and Cold Chain Distribution in Russia

Ahead of Cool Chain Russia & CIS 2014, taking place 23 - 25 April, 2014 in Moscow, Russia, Mikhail Khazanchuk, Quality Control Manager at Novo Nordisk, spoke to Cold Chain IQ about the broken cool chain in Russia. Kh azanchuk shares his insights on the introduction of GMP guidelines into Russia last year and the relationship between pharmaceutical manufacturers and distributors.

Cold Chain IQ: Please could tell us a bit about your background?

M Khazanchuk: I qualified as a technical engineer and started my career over 10 years ago. Originally, I worked in the FMCG area, which is the production of food products, cosmetics, etc. For the last five years, I have worked in the pharma industry. My experience is linked to the operations of Novo Nordisk, and I am mostly focusing on the implementation of the Good Distribution Practice in our branch and on relations with pharmaceutical distributors. So I represent the area of cool chain distribution.

Cold Chain IQ: It is believed that Russia is about to introduce GDP guidelines. Do you agree, and what prerequisites can you see for this happening?

M Khazanchuk: I am not sure if we are on the brink or not. But in any case, I hope it is so. In October, we officially introduced the GMP guidelines; this was effectively a bill prepared by the Ministry for Industry and Trade in summer, which was officially approved in October. So in my view, the logical follow-up to this legislation would be to introduce the Good Distribution Practice. I think the regulators are well aware of the fact that it is one thing to manufacture a compliant product and quite another to organise compliant storage and transportation. This is where we see the greatest amount of violations which lead to wastage. In any case, judging by what I have been hearing from the regulators at various conferences, they are well aware of this problem. This is why I think that the introduction of GMP guidelines is in fact the starting point for the introduction of GDP in Russia.

Cold Chain IQ: How would you describe the development of the cool chain market in Russia? How far behind Europe is Russia at the moment, and what needs to be done to reduce this lag?

M Khazanchuk: I think we need to agree on the criteria that indicate to what extent we are lagging behind Europe in terms of cool chain logistics. The situation is primarily linked to the absence of any requirements regulating the organisation of cool chain logistics. So if we look at what is on offer in terms of consultation (I mean the experts who could give practical insights on what has to be done in order to create a cool chain), what is on offer in terms of temperature controlling devices: temperature-regulated packaging, temperature indicators or recorders, we are very much behind Europe in this regard. And of course, I myself, like many other representatives of pharma companies, have had the experience of coming to a storage facility and realising that there is a lot of work to be done. I don’t think that there is such a thing as an unbroken cool chain in Russia at the moment. [inlinead] Cold Chain IQ : In your opinion, what are the key regulatory initiatives that have been put forward in Russia over the last two years in terms of the cool chain market, and why?

M Khazanchuk: To be honest, I am not aware of any serious initiatives that could have any impact on the cool chain market. I have recently heard that a draft regulation on the transportation of temperature controlled products may be green-lit in the Roszdravnadzor [Federal Service for the Supervision of Healthcare and Social Development]. This may be one of the initiatives that potentially could have an effect on the topic we are discussing today. But over the last few years, I have not really seen any legislative initiatives. I do not know any. There are certain standards which were mostly created after 2010, when Federal Law No. 61 was passed. After this, there has been no significant change.

Cold Chain IQ: It has been said that it is impossible to create a controlled cool chain in Russia. Could you name the main reasons why it is impossible to introduce such a chain in Russia today?

M Khazanchuk: I think it is important to stress not that it is impossible, but why it cannot be done at the moment. I mean, we cannot have a cool chain in Russia at the moment for the simple reason that there are no legal standards that would make it mandatory for all temperature-controlled products and not just the immunobiological drugs. A cool chain means that we can reconstruct the history of storage and transportation from the moment the product leaves the production facility if we need to. At the moment, in the absence of legal requirements, it is impossible to reconstruct such a history. Yes, we have a temperature controlled environment at some stages of storage and transportation, but that is not a cool chain. I’d say we have some individual elements of control, but there is no cool chain in the sense of, as I said, the opportunity of ensuring the tracking of storage and transportation of drugs in temperature controlled conditions. And I think that the ultimate cause of this is the absence of the required legal landscape.

Cold Chain IQ: You have mentioned some amendments that may be put forward by the regulator. As far as I understand, these would be amendments to Federal Law No. 61 "On the Circulation of Pharmaceuticals". In your opinion, is the market currently ready for such amendments to be introduced? I realise that you are not a regulator and that you may have your own personal point of view. But as an expert, how would you evaluate the likelihood of such amendments being approved in the nearest future?

M Khazanchuk: I think that first of all, Federal Law No. 61 is a Federal law, so we cannot expect any major changes to it in terms of cool chain logistics. I think that these may be some kind of secondary by-laws that are approved on a lower level, at Roszdravnadzor or some ordinances of the Ministry of Healthcare that regulates the circulation of drugs. Many changes have been discussed lately, and some additional changes to this law may be in the pipeline, but these concerned completely different areas, regulatory, clinical trials, and a number of other issues that may not be directly relevant for the problems we are discussing now.

At present, I am afraid that what is meant when controlled cool chain is mentioned on the Russian market are in fact immunobiological products, although they are not the only products that must be transported and stored in temperature controlled conditions. This is why future legislation may be simplified when the term "bioproduct" is introduced. But speaking of changes we have seen or heard discussed, I could not say that we can expect any changes in the area of cool chain logistics regulation.

Cold Chain IQ: The relationship between the manufacturers of pharmaceutical products and the distributors. How effective is this interaction in the current system, and what can and should be changed at the moment?

M Khazanchuk: This is quite a delicate area for discussion because any interaction between pharma companies and distributors immediately raises questions in terms of anti-monopoly legislation. I think there is virtually no cooperation at the moment when it comes to quality assurance, the compliance with good distribution practice, between pharma companies and distributors. It is true that a number of pharma companies are trying to find ways to pass on their expertise and experience, and there are a number of instances when distributors are ready to cooperate and ask, for instance, for an audit that can establish to what extent they are compliant with good distribution practice guidelines as they are understood in the EU. But I don’t think this interaction is effective enough.

First of all, there is largely no demand for cooperation in terms of cool chain logistics or ensuring quality from distributors, because in a sense the only thing a pharma company is entitled to demand of the distributors is to have a pharmaceutical license and that is it. The rest are additional requirements put forward by pharmaceutical companies. So there are some regulatory restrictions there. But in a number of cases distributors who have been working in partnership with some large pharma companies for years are ready to communicate; they make the first step and contact the pharma companies asking them to help them set up a quality assurance system, a EU GDP compliant system. Such things exist, but they are few and far between.

I think that if Russia introduces GDP guidelines, there will be a demand from distributors, because pharma companies, especially the multinationals, have a lot of experience and I am sure they will be prepared to share that. If there is demand from distributors, I am sure that such cooperation will take off. As an example, I suppose we can use the relations between pharma companies and organisations in charge of storage and transportation of drugs used in clinical trials. This is an area where is a very close interaction, because this is not a sale and purchase relationship, but the provision of a service. This is why such companies are interested in complying with the requirements of international pharma companies. So when we hold audits of such organisations we notice that the level of GDP compliance and the awareness of current quality assurance standards is much higher. Moreover, they are eager to invite representatives of pharma companies to hold training sessions of all kinds. I think this is caused by a demand for quality services provided by such organisations, and the desire to gain new knowledge and experience from pharma companies.

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Novo Nordisk's Quality Control Manager Mikhail Khazanchuk on GDP and Cold Chain Distribution in Russia

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