Compulsory liCensing for pharmaCeutiCals in russia Licensing in Russia… · Compulsory Licensing...

Compulsory liCensing for pharmaCeutiCals in russiaThe Public Health Risks and Negative Commercial ImplicationsA Briefing Paper, August 2014

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Compulsory Licensing for Pharmaceuticals in Russia The Public Health Risks and Negative Commercial Implications 2

This report was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA). The views represented here are those of the authors only.

Copyright © Pugatch Consilium 2014

The moral right of the authors has been asserted.

All rights reserved. Without limiting the rights under copyright reserved above, no part of this publication may be reproduced, stored or introduced into a retrieval system, or transmitted, in any form or by any means (electronic, mechanical, photocopying, recording or otherwise), without the prior written permission of both the copyright owner and the publisher.


list of abbreviations 4

exeCutive summary 5

introduCtion 7

1 Compulsory liCensing in the international Context: 9 limitations to its use

1.1 International boundaries of compulsory licensing for pharmaceuticals 9

1.2 Current discussions on compulsory licensing in Russia 10

2 negative impliCations of Compulsory liCensing 13 for publiC health in russia

2.1 Limitations on R&D and manufacture of innovative medicines 13 in national areas of need

2.2 Limitations on actual cost containment 15

2.3 Lack of local capacity to supply in a timely and safe manner 16

3 negative impliCations of Compulsory liCensing 19 on the russian eConomy

3.1 Building imitative vs. innovative industries 19

3.2 The adverse effects of compulsory licensing on building the biopharmaceutical 20 industry and the benefits of a voluntary approach that upholds IPRs

4 ConClusions and arguments against the use 24 of Compulsory liCensing in russia

figures Figure 1 Strength of pharmaceutical IPRs vis-à-vis clinical trial activity, 2011

Figure 2 Generic penetration and market share in Russia and select key markets, 2013

Figure 3 FDI inflows in the drugs and pharmaceuticals sector in India, 2011-14

Figure 4 FDI in biomedical R&D in Singapore

Contents


arv Anti-retroviral

Cl Compulsory license

fas Russian Federal Anti-Monopoly Service

fdi Foreign domestic investment

gdp Gross domestic product

gmp Good manufacturing practices

hiv/aids Human immunodeficiency virus/ acquired immunodeficiency syndrome

imd Incrementally modified drug

imf International Monetary Fund

ip Intellectual property

iprs Intellectual property rights

nme New molecular entity

r&d Research and development

rdp Regulatory data protection

trips Trade-related Aspects of Intellectual Property Rights

Who World Health Organization

Wto World Trade Organization

list of abbreviations


This paper outlines key arguments against the use of compulsory licensing in Russia both from the perspective of patients as well as the domestic economy and pharmaceutical industry. It takes into consideration the current Russian context, including the needs and stated desires of the Russian government in relation to public health and the economy, as well as existing empirical literature and experience from other countries that have actively used compulsory licenses.

Overall, the paper finds there to be the potential for several negative implications to arise from the use of compulsory licensing and the introduction of stricter standards for the patentability of medicines. The following statements sum up these findings:

1. Compulsory licensing would jeopardize patient safety.

• Too many Russian manufacturers lack capacity to ensure drugs produced under a compulsory license meet international safety and quality standards; only around 30% of producers currently comply with GMP.

• Substandard medicines can lead to adverse drug reactions and faster than normal drug resistance.

2. Compulsory licensing would not secure greater access.

• Significant price reduction may not be achieved; generics in Russia are typically higher priced than in other countries (over 70% of the time), and at times more expensive than the original drug.

• It fails to address other barriers to access, such as inadequate resources for delivery especially in peripheral regions and gaps in reimbursement (60% of prescription drugs in Russia are paid for out-of-pocket).

• It impedes alternative access channels by discouraging clinical trials and local drug development.

3. Compulsory licensing would generate economic and commercial damage.

• Deteriorating IP environments discourage foreign investment in biopharmaceutical R&D.

• Reduced investment in R&D limits local production of innovative medicines; the volume of locally produced drugs sold in Russian pharmacies already dropped by 7% between Q2-2013 and Q2-2014.

4. russia’s use of compulsory licensing would conflict with international standards.

• The TRIPS Agreement permits compulsory licensing on a limited basis (such as national emergencies) and as a measure of last resort.

• Its use for commercial purposes would create a hostile negotiating environment in Russia and introduce challenges to achieving coverage in its programs for specialty medicines.

5. voluntary options exist that would secure a far better outcome.

• Short-term solutions include cost-sharing and targeted enhancing of coverage, such as a new scheme for orphan drugs considered by the Russian parliament in 2014.

• Long-term capacity building in R&D, manufacturing and healthcare delivery is already underway in Russia, including new biomedical research clusters and R&D tax incentives.

• Alternative mechanisms such as these create a collaborative environment and fundamentally improve access to medicines.

exeCutive summary

Compulsory licensing for pharmaceuticals in russia The Public Health Risks and Negative Commercial Implications 6


Throughout 2013-14 the Russian Ministry of Health, Federal Anti-Monopoly Service and key opinion leaders in Russia have raised the use of compulsory licensing as a pharmaceutical cost containment tool. Most recently, in February 2014 the FAS proposed authorizing compulsory licenses as a manner of mitigating costs of drugs in certain areas of public health.1 Concurrently, compulsory licensing was also raised by Larisa Popovich of the Institute of Health Economics as one tool for increasing access to advanced medicines in areas of high need.2

Compulsory licensing, which refers to the government-authorized manufacturing of a patented product or process without the patent owner’s permission, is typically targeted towards innovative, high-cost drugs.3

Globally, the use of compulsory licensing as a price control tool for innovative medicines, especially in developing countries, has continued to expand in the past several years, with India, Indonesia and Ecuador all issuing compulsory licenses in 2012. While compulsory licensing provisions have always existed in Article 31 of the TRIPS Agreement, the tool has garnered greater attention since the 2001 Doha Declaration on TRIPS and public health. A number of developing and least developed countries have evoked compulsory licensing in an effort to expand access to existing medicines, often in relation to HIV/AIDS treatments, and more recently, cancer therapies and chronic or non-communicable diseases.

The issue of compulsory licensing has spurred many debates concerning its actual impact on public health and the domestic economy in countries that make use of the mechanism. On the one hand, from the perspective of countries using compulsory licensing, the instrument has been ostensibly aimed at providing access to crucial medicines that are considered to be beyond the purchasing power of these countries and population groups, although it can and has been used as an instrument of industrial policy with little impact on access. On the other hand, from the perspective of patent owners, compulsory licensing erodes their ability to exercise the exclusive rights associated with the patent. Although legal and empirical arguments are made on both sides of

the debate, the more fundamental questions remain as to whether compulsory licensing has had the intended impact as well as whether there have been unintended and unfavorable effects. For instance, to what extent has the use of compulsory licensing increased access to medicines, and at what cost? Moreover, how do these tools impact economic activities in the biopharmaceutical sector, particularly in countries that issue compulsory licenses? In fact, the most recent studies and evidence from countries that have issued compulsory licenses, particularly developing countries, suggest that it can have several negative effects on patients and on the local economy.4

The following paper discusses key arguments and evidence drawn from international experience concerning the negative implications of compulsory licensing on patients and on the local pharmaceutical industry. These arguments are presented through the prism of Russia’s current public health and economic considerations. Section 1 provides a background discussion on the perceived need for compulsory licensing in Russia and existing public health and industrial challenges/objectives in the country. Section 2 presents existing empirical evidence from Russia and other countries concerning potential negative outcomes for Russian patients and the health system of the active use of compulsory licensing. Section 3 discusses implications of compulsory licensing for the Russian pharmaceutical industry and economy, in light of Russia’s stated intent to build a local innovative industry and secure its own long-term supply of medicines. Section 4 provides conclusions and a summary of the main arguments against compulsory licensing presented in the paper.

introduCtion


1.1 international boundaries of compulsory licensing for pharmaceuticals

TRIPS Article 31, including the amendments introduced in the 2001 Doha Ministerial Declaration, and subsequent General Council decision allowing the export of medicines produced under a compulsory license (outlined in Paragraph 6), form the legal grounds for compulsory licensing for medicines. The main requirement is that developing countries must first seek to engage with patent owners to access a given medicine at a lower price, for instance through price negotiations or voluntary license agreements.6 Failing this, they may issue a compulsory license to produce the drug in generic form. It is also possible to issue a compulsory license without first seeking a voluntary license in certain limited circumstances: national emergencies, other urgent circumstances and where the drug will not be commercialized but rather provided at no charge by the government. However, the Chairman’s statement accompanying the General Council decision (concerning Paragraph 6 of the Doha Declaration) underscores that these provisions are not in any way intended for industrial or commercial objectives, and if used, it is expected that they would solely be aimed at protecting public health.7

A key issue in the global debate on compulsory licensing deals with what an adequate effort at a voluntary agreement should look like as well as how to define the appropriate circumstances for issuing a compulsory license without first seeking a voluntary license. The debate is not black and white, with various rationale, such as “public health emergencies” and “anti-competitive behavior”, being defined differently by different parties.8

To the extent that TRIPS permits the use of compulsory licensing in cases of national emergencies, it is clear that the spirit of Article 31 and of the Doha Declaration is that compulsory licensing represents a “measure of last resort”, particularly due to its extreme effect on the market for the targeted drug and negotiating relationships. Specifically, in line with game theory and the classic prisoner’s dilemma, the repeated use of compulsory licensing tells patent owners that the country is not interested in cooperation and collaboration, and will lead them to also be less collaborative. Under these circumstances, compulsory licensing will be less effective and related objectives, such as lowering prices, enabling supply in areas of unmet need and facilitating sharing of know-how and technology, will be less achievable. Accordingly, compulsory licensing is intended primarily for public health and humanitarian emergencies, and not for commercial or political objectives, and to be used only after all other options for negotiating pricing and supply have been exhausted.

The proposed granting of compulsory licensing for pharmaceuticals in Russia is primarily justified on two grounds: 1) provisions in the TRIPS Agreement – commonly known as TRIPS “flexibilities” – aimed at allowing developing and least-developed countries to manufacture copies of patented medicines in certain, limited circumstances; and 2) the perceived positive experience of countries that have issued compulsory licenses in the past.5

Compulsory liCensing in the international Context: limitations to its use1

over the past 15 years developing countries have used compulsory licensing infrequently and mainly for pandemics.


1 Compulsory liCensing in the international Context: limitations to its use

Instead of focusing on the legal basis for issuing a compulsory license, this paper examines the way in which compulsory licensing has affected countries that have used the instrument.

Over the past 15 years, different developing countries have exercised Article 31 to issue or to threaten the issuing of compulsory licenses.

Still, despite the extent it has been discussed, compulsory licensing has actually been used fairly infrequently (in roughly 20 instances), and mainly in respect to pandemics such as HIV/AIDS and flu, and in a few cases for oncology medicines.

It is also worth noting that since 2010 India has become one of the more active countries in the consideration and issuance of compulsory licenses as well as administrative and judicial decisions that limit patent protection in a similar manner. In particular, in addition to its issuing a compulsory license on the cancer drug Nexavar®, the 2012 and 2013 decisions on the oncology treatments Glivec®, Sutent® and Tarceva® have effectively limited the ability of innovators to exercise in India the patent rights they hold in other major jurisdictions.

The general assumption by proponents of compulsory licensing is that the exercise of these measures has mainly resulted in benefits to Indian patients and the Indian economy, in the form of lower drugs prices, better access to advanced medicines and a boon for the local industry (including a benign effect on investments by research-based companies).9 However, as section 2 will show taking a more profound look at the public health and economic effects of these measures in India in a substantial number of cases points rather to an inability to achieve their specific, intended objectives as well as wider, negative consequences.

1.2 Current discussions on compulsory licensing in russia

It is in consideration of the above trends and the perceived benefits as well as the current economic situation in Russia that the Russian government and its policy advisors have raised the possibility of issuing compulsory licenses as a manner of containing health and pharmaceutical spending.

Over the past six to nine months, Russia has begun to face dire economic circumstances that are weighing on, among other areas, its health budget. In particular, projections on economic growth have shifted markedly and abruptly since last year. According to the IMF, 2014 GDP growth rates are now forecasted at 0.2%, down from an expected 3.3% (based on mid-2013 projections), with only as much as a 1% pickup in growth expected in 2015 by the most optimistic estimates.10 Geopolitical factors, especially the Crimean crisis and the violence in Ukraine, and subsequent sanctions by Western countries, have further compounded the situation. These events have exposed major structural imbalances in the Russian economy (namely overreliance on the energy sector) and subjected it to substantial capital flight – $90-100 billion is anticipated by the Bank of Russia by the end of 2014.11 Accordingly, healthcare expenditure is only expected to grow 0.8% in 2014 (down from over 10% in 2013), with pharmaceutical spending also falling (from growth rates of 8.4% in 2013 to 4.6% in 2014).12

in light of increasing budgetary pressures, russian authorities have proposed compulsory licensing as one policy instrument for reducing drug costs and improving access to certain innovative medicines.


1 Compulsory liCensing in the international Context: limitations to its use

Facing a significantly tighter health budget than expected in 2014, Russian policymakers have intensified their focus on various cost containment measures including stricter price controls; requirements for domestic manufacturing of drugs; and compulsory licensing.13 In this light, certain officials have suggested that Russia should amend its Civil Code and other relevant legislation to provide for the exercise of TRIPS flexibilities in areas of “special need”. (Currently the Civil Code only provides for compulsory licensing for military orders.) These areas have not yet been publicly elucidated; compulsory licenses have been recommended for a “limited” number of medicines and health technologies, and for a “limited” time period, but further detail has not yet been provided.14

The discussions in Russia on the active use of compulsory licensing often refer to countries that have exercised this tool. In particular, India has been cited as an example to follow for using compulsory licensing to lower prices of drugs.15

It is worth emphasizing that in these discussions – which have been framed around the local manufacture, rather than importing, of compulsory licensed-medicines – the focus is mainly on the anticipated effect of lowering drug prices.16 Thus far, any negative implications related to patient safety and the actual availability and affordability of advanced treatments in Russia, as well as any harm to FDI, do not appear to have been a major part of the public discussion.

Nevertheless, when considering Russia’s objectives and assumptions concerning compulsory licensing in light of other countries’ experience and the current public health and economic situation in Russia it is possible to identify several negative implications that could arise from the use of compulsory licensing there. The following section will outline these considerations and supporting empirical evidence from Russia and other countries.


In particular, the eroding of patent protection and circumventing of established public health safeguards that can be associated with compulsory licensing may have significant, unintended and undesirable outcomes for patients, both in the short-term and long-term. This section will analyze several negative outcomes based on empirical data from Russia and other countries that have exercised these instruments, including India, Brazil and Thailand.

2.1 limitations on r&d and manufacture of innovative medicines in national areas of need

The Russian government has indicated a pressing need for innovative medicines in various areas. First, under its Pharma 2020 Strategy, 60% of patented drugs are targeted for local production by 2020.17 Second, identifying compulsory licensing as a potential instrument for accessing medicines in itself indicates a desire to supply Russian patients with new and advanced medicines as rapidly as possible, since patent-protected medicines are generally the most current and cutting-edge treatments available. Moreover, the Russian government has identified key areas where specialized medicines are in high demand, including cancer and rare diseases. For example, the Seven Nosologies Program (VZN in Russian) provides coverage for highly specific treatments for rare diseases such as

multiple sclerosis and cystic fibrosis.18 Through such programs, it would appear that the Russian government both has the need and sees value in making new and advanced treatments available to its population.

In this light, some of the most direct, rapid and low-cost methods for countries to provide access to innovative medicines are by facilitating participation in clinical trials and close proximity of manufacturing. While the timing and costs vary study by study, generally speaking clinical trial volunteers are provided with the newest treatments or uses of existing treatments often well ahead of the drug being made available to the wider market and at a substantially lower cost. Indeed, it can be the case that many of the research costs, such as the drug itself and tests done for the purpose of the trial, are borne by the study’s sponsor.19 In addition, in some cases, the sponsor may continue to provide the treatment, for instance, at a preferential price.20

Moreover, the ability to manufacture a product domestically can in some cases lower the cost of producing and distributing it through the existing global supply chain.21 The greater the possibility of conducting advanced manufacturing operations for a given product in a country (where it is most cost effective to do so), the more likely that overall costs of producing the medicine could be less and health systems and patients could face lower prices for that product than would otherwise exist.

There are also long-term benefits to facilitating the growth of a domestic innovative pharmaceutical industry. Having the capacity to conduct a large portion of the R&D and manufacturing process domestically, as long as other important factors are in place, can translate into a steady and stable supply of medicines in a given country.22

Although in theory the use of compulsory licensing to produce generic versions of advanced medicines should lead to a reduction in prices for, and greater access to, such medicines, in practice these effects are not necessarily achieved.

negative impliCations of Compulsory liCensing for publiC health in russia2

the active exercise of compulsory licensing has the potential to reduce incentives for investment in domestic r&d and manufacturing of new medicines. as such, it conflicts with the government’s need and intent to supply innovative treatments to the russian population, both in the short and long-term.


2 negative impliCations of Compulsory liCensing for publiC health in russia

Taking these points into account, there is a clear need to maintain the incentives for research-based biopharmaceutical companies to invest in clinical trials and manufacturing of medicines in Russia. However, economic theory and empirical data suggests that as a key factor in the development and marketing of biopharmaceuticals, and as such an incentive for biopharmaceutical investment, erosion of IPRs including through compulsory licensing weakens such investment (this link will be discussed further in section 3). Moreover, existing evidence linked to the issuing of compulsory licenses suggests that it can be associated with a lower level of pharmaceutical investment.

In fact, a weakening of the IP environment in a given country, including through the discussion and actual issuance of a compulsory license, is

associated with a reduction in the number of clinical trials taking place in that country (as a proxy of pharmaceutical FDI). Comparing legal and de facto IP protection, such as the use of compulsory licensing, with the number of clinical trials, Figure 1 suggests that countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies.23 Of note, India, with its relatively weak level of IP protection, also has a very low number of total clinical trials taking place there. Even using the most recent data, India’s total number of clinical trials in 2014 is at around 2,400, a figure behind all other BRICs.24

The case of India suggests that by actively using the compulsory licensing instrument Russia risks weakening this important channel for accessing innovative medicines.

figure 1 Strength of pharmaceutical IPRs vis-à-vis clinical trial activity (2011)

Pharmaceutical IP Score CTs per region per million population

Thai

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100

150

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Source: Pugatch & Chu (2011), Clinicaltrials.gov25



A similar lesson seems to exist in relation to growing a strong base of local manufacturing of innovative medicines. A 2013 survey of top locations worldwide to invest in advanced manufacturing facilities for biopharmaceuticals and biotech shows that companies view India as a less attractive environment and are investing less there in comparison to 2012. In fact, India’s attractiveness for advanced manufacturing has plummeted as it has become much more active towards compulsory licensing; between 2012 and 2013, the percentage of respondents who said the likelihood of investing in India existed dropped by half – from 13.3% in 2012 to 7% in 2013.26 This means that Russia’s biopharmaceutical manufacturing industry could face additional challenges to effectively bringing drug production closer to home (and potentially lowering costs of medicines) if it pursues the active use of compulsory licensing.

2.2 limitations on actual cost containment

Manufacturing a generic version of a drug under a compulsory license does not mean that it will necessarily lower the price of the drug or that the price will be sufficiently affordable so as to increase access to the drug to the anticipated level. Prices of generic drugs in Russia are generally known for being quite high relative to the volume of generic uptake. Specifically, in Figure 2 although generics represent a large share of the pharmaceutical market, the value of the generic market is also relatively high.27 Indeed, according to the Russian

figure 2 Generic penetration and market share in Russia and select key markets, 2013

Penetration (volume) Market share (value)

Russia%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Germany US UK

116 146

Source: Pugatch Consilium based on BMI (2014), IMS Health (2013), McKinsey (2013) 28

73%

38%

79%

19%

80%

18%

70%

21%

the existence of high relative generics prices in russia suggests that the ability to achieve sufficiently lower prices through compulsory licensing may be limited.


Ministry of Health the prices of generics in Russia are at times higher than the original drug.29

Looking at the effect of compulsory licensing specifically, in other countries it is possible for generic production under compulsory licenses to only increase the population that can afford the drug slightly. Returning again to the case of India, according to some calculations producing a generic version of Nexavar on the basis of the compulsory license has lowered the price to the extent that there is only a small increase in the percentage of the population that is able to afford the drug.30

It is therefore possible that despite seeking to lower the price of certain drugs through a compulsory license, the eventual price at which the drug is provided to the Russian public may not be much, if at all, lower than the price at which the original drug is being made available in Russia. As such, and even more in the light of the other risks discussed below, it is important to consider whether the price of a drug achieved through producing it under a compulsory license would outweigh the other associated risks to patients.

2.3 lack of local capacity to supply in a timely and safe manner

In some regards, locally manufacturing generic versions of advanced drugs may represent a case of “putting the cart before the horse”. In other words, this process expects domestic producers to be able to rapidly manufacture a drug of comparable quality to the innovative version when they may not be sufficiently prepared or equipped or the adequate safeguards and standards are not in place to ensure the safety and quality of the supply chain. This presents serious risks to patients and costs to health care systems, both in terms of the potential for adverse drug reactions as well as for faster than normal drug resistance.

For example, studies on the process and effects of producing generic versions of the HIV/AIDS drug (Stocrin) compulsory licensed in Brazil in 2007 suggest that there was in practice a lack of internal capacity to manufacture the drug.31 This led to delays in the availability of the drug in the Brazilian market, and over the long-term the Brazilian-manufactured product failed to meet local demand for the drug.32

Just as, if not more, importantly, in some cases the generic drugs produced by domestic companies and manufacturing facilities using a compulsory license do not meet international standards of quality, safety and efficacy. For example, several drugs such as anti-retrovirals and cardiovascular medicines produced locally in Brazil and in Thailand, respectively, based on compulsory licenses were not included on the WHO’s Prequalification Program, one standard indicating quality of medicines.33 In other words, while innovative medicines are generally required to meet a high standard that assures they are safe and suitable for human use and will have the intended therapeutic consequences, drugs produced by local manufacturers under a compulsory license too often do not meet these same standards. This may be due to lack of GMP, inadequate review by drug regulators and/or lack of a robust pharmacovigilance system.34 The availability of substandard medicines in a country represents a serious threat to public health, with potentially detrimental and sometimes lethal health outcomes for patients.

A second negative outcome that could result if manufacturers are ill-suited or ill-equipped is that, especially when it comes to infectious diseases, substandard medicines tend to face drug resistance faster than would otherwise be expected.35 As a result, patients more quickly require stronger treatments, with the associated costs of providing access to them. This was the case in Thailand with domestically-produced ARVs. For example, in the case of a locally-produced copy of GPO, known as GPO-Vir, the US Centers for Disease Control and Prevention and Thailand’s Mahidol University documented an extremely high rate of drug resistance in patients treated with the locally-produced versions of the drug (roughly between 40% and 60%), requiring them to be switched to a stronger treatment.36


inadequate capacity among local russian manufacturers, such as meeting gmp standards, means that under a compulsory license they run the risk of producing substandard drugs and/or delaying their availability.



These factors are crucial to consider in Russia’s case. Although Russia is in the process of introducing international regulatory standards governing drug quality, safety and efficacy, such as GMP, in practice these standards are not fully operational and enforced. The Russian government has recently pushed back the deadline for local manufacturers to meet GMP standards to 2016 (it was initially 2014).37 According to various sources, currently only around 30% of domestic manufacturers comply with GMP standards.38 This implies that many domestic manufacturers run the risk of producing drugs which are not safe for Russian patients. In addition, these may over the long-term increase the costs of treatment as newer and/or non-resistant treatments are required sooner than expected and other, related costs, such as hospitalization, are possibly incurred. Over the longer run the full implementation of international regulatory standards as well as greater investment in building advanced local manufacturing capacity would aid in strengthening the domestic production of safe and high-quality medicines.

This section has outlined several negative implications of compulsory licensing for patients, including how the instrument may present undue safety risks, hinder access to advanced, needed medicines, and not lessen but perhaps (albeit from different angles) even heighten the pressure on the public health care budget. It is also crucial to consider the potential economic and industrial effects of compulsory licensing, which also have important implications for patients.


Active use of compulsory licensing may jeopardize foreign investment in the Russian biopharmaceutical sector and its development.

3 Negative implicatioNs of compulsory liceNsiNg oN the russiaN ecoNomy

An additional key issue at stake for Russia and its economy is the extent to which active use of compulsory licensing would damage Russia’s stated aspirations to build an innovative biopharmaceutical industry. Specifically, what effect would compulsory licensing have on the ability to attract investment in basic manufacturing operations versus in advanced manufacturing and R&D facilities?

Over the past five years, Russia has sought to grow an innovative pharmaceutical industry, with the idea of improving its ability to supply its own market with needed medicines as well as diversifying the Russian economy and bolstering its global competitiveness. The primary channel for realizing these objectives is through its Pharma 2020 initiative, which was introduced in 2009-10. Pharma 2020 has as one of its key goals to by 2020 increase local companies’ share of the total pharmaceutical market value to 50% (in 2012 the share was about 20%) and, as mentioned, raise the share of patented medicines produced domestically to 60% of the market in terms of value.39 An additional aim is to increase drug exports eight times by 2020 compared to 2008 levels.40

Inherent in achieving these objectives is the development of a domestic base of biopharmaceutical R&D and advanced manufacturing facilities, including high levels of expertise, sophisticated infrastructure and adequate quality control.41 Today, the majority of production operations taking place in Russia are at a very basic level. For instance, as of 2011 the large majority of pharmaceutical substances processed in Russia were imported; only around 35% (in volume) of advanced processing of substances used in local production took place in Russia, with only 15% of these produced locally.42 In addition, only 2% of biotech substances processed in Russia were produced in the country.43 Moreover, a recent survey of

biopharmaceutical industry representatives and government officials confirms that in regard to its manufacturing capabilities Russia is struggling to compete vis-à-vis other countries.44 Problematic areas included the lack of a mature system for controlling the importing and production of pharmaceutical ingredients, and the availability of pharmaceutical products, including APIs.45 In regard to R&D, as one indicator of the level taking place in Russia, the number of clinical trials conducted there is still fairly small on an absolute and per capita basis. Russia currently has 2,661 registered trials in operation, compared to 3,804 in Brazil and 4,793 in China (as mentioned, India has an even lower number, at 2,407).46

3.1 building imitative vs. innovative industries

In order to gain ground towards truly building a local industry capable of producing and exporting advanced biopharmaceuticals it is particularly relevant for Russia to consider what type of biopharmaceutical investment its policies and environment may lend to.

Specifically, it is possible to identify two broad types of biopharmaceutical (and more generally, high-tech) investment: imitative and innovative. An imitative industry, for instance one that focuses on the production of generic medicines, may actually flourish under an environment that does not provide strong IP protection and requires less sophisticated investment including

developing an innovative biopharmaceutical industry in russia requires a different set of conditions than those that are permitting the growth of its generic sector, including but not limited to investment in local research and manufacturing capacity by multinational research-based companies.


3 negative impliCations of Compulsory liCensing on the russian eConomy

from foreign research-based companies. The policy focus of the Indian Government on the generics industry based on its environment prior to its full implementation of the TRIPS Agreement and the introduction of pharmaceutical patents is a prime example of how a weak level of biopharmaceutical IP protection can stunt the development of a research-based industry (which has a more beneficial impact throughout the domestic economy than an imitative industry).47

Building an innovative industry capable of advanced R&D and manufacturing operations requires a certain set of factors, including attracting sufficient levels of FDI and technology transfer.48 Indeed, international experience suggests that one of the most direct and fastest ways of building local innovative capacity is through partnering with existing multinational innovative companies such that these companies invest a portion of their operations, laboratories, factories, etc. in the country, and employ local and foreign scientists, technicians and clinicians there.49 In this way, cutting edge technologies, know-how and overall capacity are transferred and built up domestically. Singapore is an example of a country that since the early 2000s has successfully developed a competitive advantage in the sector of biomedical sciences through fostering regular public-private partnerships that have led to advanced R&D. For instance, Singapore has established platforms for matching companies’ R&D needs to expertise in research hospitals and institutions.50 In this context, Singapore has developed world-class R&D and manufacturing capabilities and has seen tremendous growth in investment by multinational research-based companies – manufacturing alone is estimated at SGD23 billion.51

As another example, over the last decade the Korean pharmaceutical industry has transformed from focusing on basic manufacturing operations into a fully-fledged, globally competitive innovative industry. Key factors of this evolution include a marked strengthening of regulatory and intellectual property standards towards international levels, technological capacity building through dedicated government funds and technology transfer agencies, and fostering of a number of strategic partnerships and licensing agreements with multinational research-

based companies.52 For instance, several US, European and Japanese companies have invested an estimated $50 million-$250 million over the last five years.53 In turn Korea has built up a leading biopharmaceutical industry including the local development and production of new drugs and a strong clinical trials sector. Today, Korea ranks among the top 10 countries worldwide as a host for clinical trials, with more than 5,200 clinical trials in operation in 2014.54 As of 2013, at least 20 NMEs and 30 IMDs developed in Korea, including orphan drugs, have been approved and launched in the local market, and over 600 innovative molecules are currently in various stages of development.55

3.2 the adverse effects of compulsory licensing on building the biopharmaceutical industry and the benefits of a voluntary approach that upholds iprs

Existing empirical literature suggests that to garner the needed investment and knowledge and technology transfer to build an innovative industry, and experience the associated economic benefits, requires a strong IP environment – including in relation to compulsory licensing – along with a range of other factors supporting biopharmaceutical investment.

In particular, the literature indicates that there is by and large a positive link between the strength of IPRs and economic activities contributing to building and supporting innovative capacity in countries. For example, Cavazos, Lippoldt and Senft find that a 1% increase in IP protection (measured by the Patent Rights Index) leads to a 2.8% increase in FDI and an over 2% rise in knowledge capital (as measured by trade in services).56 In addition, analysis of 16 countries over the period 1982-1999 shows that technology transfer (as exhibited by levels of royalty payments) from multinational companies to their affiliates increased at the time of IP reforms, as did affiliates’ R&D expenditure.57

Continuing to strengthen and improve russia’s ip regime, including a balanced approach to compulsory licensing, is an additional factor for the growth of the innovative biopharmaceutical industry there.


2011-12(Apr - Mar)

$

$500

$1,000

$1,500

$2,000

$2,500

$3,000

$3,500

2012-13(Apr - Mar)

2013-14(Apr - Feb)

116 146


As a natural progression of this link, recent data also indicates that improvements to IP protection in a given country are associated with greater levels of innovative activity in that country. For instance, one study finds that patent protection has a significant impact on rates of innovation; this correlation is particularly strong for countries which have reached a certain technological capacity and level.58 Another analysis compares the IP environment in countries with the size and scope of multinational companies’ assets there, including properties, plants and equipment, employee compensation, foreign technology transfer and R&D expenditure, and finds that such assets increase when IPRs are strengthened.59

In this context, measures or standards that erode the level of IP protection afforded can have negative implications for attracting the investment and partnerships from foreign companies that are needed for growing a local innovative biopharmaceutical industry.

Returning again to the example of India, coinciding with the marked rise in the use of and discussion concerning compulsory licensing since 2012, the Indian government itself has identified a drop in the level of FDI in the drugs and pharmaceuticals sector. As Figure 3 shows, according to calculations by the Indian Department of Industrial Policy Promotion, levels of biopharmaceutical FDI in the period 2012-14 dropped to 30-40% of 2011-12 levels.60

Moreover, despite recent investments by multinational biopharmaceutical companies the focus of investment is in many ways still in the generic industry or in other less advanced operations in India.62 For example, one major investment by GSK is to set up a factory for manufacturing and packaging medicines.63

Studies of other countries that have issued compulsory licenses also find a parallel drop in levels of investment. Although not the only factor, following its issuing of compulsory licenses on the HIV/AIDS treatments Stocrin and Kaletra in 2006-2007, and subsequently on the oncology drugs Taxotere, Femara and Tarceva, in 2007 Thailand saw a significant drop in FDI of $10 billion.64 In addition, broad use of compulsory licenses in Egypt is associated with heavy losses in FDI in terms of billions of dollars.65 Even the threat of issuing a compulsory license in Brazil in the late 1990s-early 2000s led to a moderate decrease in FDI there.66

In contrast countries that have provided a strong IP regime as well as a range of other incentives for biopharmaceutical investment, such as high quality human capital and infrastructure as well as a favorable business environment, tend to see higher levels of biopharmaceutical FDI.67 For instance, as Figure 4 shows, data from Singapore suggests that with the strengthening of the IP environment following the free trade agreement between Singapore and the United States there has also been a significant increase in the volume and value of FDI in biomedical research, including in clinical trials, during the same period. Improvements to the IP environment are demonstrated in an increase in the Pharmaceutical IP Index score from 3.3 to 4.4 between 2000 and 2008.

figure 3 FDI inflows in the drugs and pharmaceuticals sector in India, 2011-14

Source: Indian DIPP (2014)61

$3,232

$1,123

$1,270


The case of Mexico is another example of a country that has strengthened its pharmaceutical IP environment over the past 20 years and has also seen significant FDI in biomedical R&D over the same period. Mexico has carried out IP reforms as a result of NAFTA (which entered into force in 1994), as well as specific improvements to biopharmaceutical-related protection, reflected in a rise in its Patent Rights Index score from an average over the period 1960-1990 of 1.19 to 3.14 in 1995 and to 3.88 in 2005.69 In the first five years of sector-level data available following the introduction of NAFTA, annual FDI in R&D in natural and life sciences grew from $6.5 million in 1999 to $40.4 million in 2003, a six-fold increase.70 Moreover, between 2011 and

2012 the figure grew at a similar rate, with $40.8 million of foreign investment in biomedical R&D in 2012.71 During the same year, Mexico made incremental improvements to its regulatory data protection and patent linkage systems (issuing of guidelines providing for a 5 year term of RDP and the inclusion of formulation patents on the Official Gazette, respectively).72


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figure 4 FDI in biomedical R&D in Singapore

R&D FDI Pharma IP Index Source: Pugatch Consilium, based on A*STAR R&D Survey Statistics, 2000-200868


This paper has outlined key arguments against the use of compulsory licensing in Russia both from the perspective of patients as well as the domestic economy and pharmaceutical industry. It has taken into consideration the current Russian context, including the needs and stated desires of the Russian government in relation to public health and the economy, as well as existing empirical literature and experience from other countries that have actively used compulsory licenses.

4 coNclusioNs aNd argumeNts agaiNst the use of compulsory liceNsiNg iN russia

Overall, the paper has found there to be the potential for several negative implications to arise from the use of compulsory licensing and the introduction of stricter standards for the patentability of medicines. The following statements sum up these findings:

1. Compulsory licensing would jeopardize patient safety.

• Too many Russian manufacturers lack capacity to ensure drugs produced under a compulsory license meet international safety and quality standards; only around 30% of producers currently comply with GMP.

• Substandard medicines can lead to adverse drug reactions and faster than normal drug resistance.

2. Compulsory licensing would not secure greater access.

• Significant price reduction may not be achieved; generics in Russia are typically higher priced than in other countries (over 70% of the time), and at times more expensive than the original drug.

• It fails to address other barriers to access, such as inadequate resources for delivery especially in peripheral regions and gaps in reimbursement (60% of prescription drugs in Russia are paid for out-of-pocket).

• It impedes alternative access channels by discouraging clinical trials and local drug development.

3. Compulsory licensing would generate economic and commercial damage.

• Deteriorating IP environments discourage foreign investment in biopharmaceutical R&D.

• Reduced investment in R&D limits local production of innovative medicines; the volume of locally produced drugs sold in Russian pharmacies already dropped by 7% between Q2-2013 and Q2-2014.

4. russia’s use of compulsory licensing would conflict with international standards.

• The TRIPS Agreement permits compulsory licensing on a limited basis (such as national emergencies) and as a measure of last resort.

• Its use for commercial purposes would create a hostile negotiating environment in Russia and introduce challenges to achieving coverage in its programs for specialty medicines.

5. voluntary options exist that would secure a far better outcome.

• Short-term solutions include cost-sharing and targeted enhancing of coverage, such as a new scheme for orphan drugs considered by the Russian parliament in 2014.

• Long-term capacity building in R&D, manufacturing and healthcare delivery is already underway in Russia, including new biomedical research clusters and R&D tax incentives.

• Alternative mechanisms such as these create a collaborative environment and fundamentally improve access to medicines.


1 Mosapteki, “FAS Russia: Drug prices should be fair”, 2/25/2014, http://mosapteki.ru/material/fas-rossii-ceny-na-lekarstva-dolzhny-byt-spravedlivymi-3508 (Translated)

2 Popovich, L. (2014), “There Still Is a Chance”, Roskaya Business Gazette, 2/11/14

3 World Trade Organization, “Compulsory licensing of pharmaceuticals”, www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm

4 See, for example: Norris, J. & Adelman, C. (2013), Compulsory Licenses under TRIPS: An Analysis of Good Intentions vs. Unintended Consequences to Patients’ Health, Hudson Institute, May 2013

5 Popovich (2014)6 TRIPS Agreement, Article 317 WTO, “The General Council Chairperson’s statement”, WTO

News, 30/8/2003, www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm

8 Bird, R. & Cahoy, D. (2008), “The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach”, American Business Journal, Vol.45, Iss.2, pp.1-48

9 See, for instance, Popovich (2014)10 IMF (2014a), World Economic Outlook Update: Is the Tide

Rising?, 1/2014; IMF (2014b), “Russian Federation – Concluding Statement for the 2014 Article IV Consultation Mission”, 30/4/14, www.imf.org/external/np/ms/2014/043014a.htm; IMF (2013), World Economic Outlook Update: Growing Pains, 7/13

11 Reuters, “Russian capital outflows shrink in April as rouble concerns ease”, 23/5/14, www.reuters.com/article/2014/05/23/russia-cenbank-capital-outflow-idUSL6N0O91XL20140523

12 BMI (2014), Russia Pharmaceuticals and Healthcare Report, Q2 2014, 3/14; BMI (2013), Russia Business Forecast Report, Q4 2013

13 Rudisill, C., Vandoros, S. & Antoun, J. (2014), “Pharmaceutical Policy Reform in the Russian Federation”, Journal of Health Politics, Policy and Law, Vol.39, No.3, pp.691-705;

14 Popovich (2014)15 Ibid.16 Popovich (2014)17 Embassy of Switzerland in Russia (2011), “Pharma 2020: The

Strategy of Development of the Pharmaceutical Industry of the Russian Federation”, www.s-ge.com/de/filefield-private/files/25703/field_blog_public_files/5244

18 Rudisill et al (2014); Grigorenko, E., “The Governmental Program for Hosting International Orphan Drug Companies in Russia”, 6th Eastern European Conference for Rare Diseases and Orphan Drugs, 2011, www.raredisease2011.org/sunular/KONFERANS/26_KASIM/HALL_A/WORKSHOP_A3/Elena_Grigorenko_The_Governmental_Program_for_Hosting_International_Orphan_Drug_Companies_in_Russia.pdf

19 Center for Information & Study on Clinical Research Participation, “Charts and Statistics: Useful information about clinical research before participating in a trial”, www.ciscrp.org/education-center/charts-and-statistics/before-participation/

20 US FDA, “Basic Questions and Answers about Clinical Trials”, www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm121345.htm

21 WHO (2011), Local Production and Access to Medicines in Low- and Middle-Income Countries, p.26

22 Ibid.23 Pugatch, M. & Chu, R. (2011), “The strength of pharmaceutical

IPRs vis-à-vis foreign direct investment in clinical research: Preliminary findings”, Journal of Commercial Biotechnology, Vol.17, Iss.4, pp.308-318

24 US National Institutes of Health, www.clinicaltrials.gov/ct2/search/map/click?map.x=546&map.y=212

25 Pugatch & Chu (2011)

26 Langer, E. “Biopharmaceutical Outsourcing Continues to Expand”, Pharmaceutical Outsourcing, 1/28/2014, www.pharmoutsourcing.com/Featured-Articles/153801-Biopharmaceutical-Outsourcing-Continues-to-Expand/

27 Rudisill, et al (2014), p.69928 BMI (2014), p.25; IMS Health (2013), MIDAS, MAT June 2013

in IMS Health (2014), “What the structure of the market will be: EU vs. CEE Feb 2014”, www.apteka.ua/wp-content/uploads/2014/02/10.pdf; McKinsey & Company (2013), Generating value in generics: Finding the next five years of growth, May 2013, p.1

29 Farmsouz.com, “Elena Maksimkina: About the problems of drug insurance and counterfeit products in Russia”, 1/31/2014, www.farmsouz.ru/interview/main-view/elena-maksimkin-about-the-problems-of-drug-insurance-and-counterfeit-products-in-russia-

30 Health India, “Despite compulsory licensing, generic cancer drug too costly for the poor,” 4/23/2013, http://health.india.com/diseases-conditions/despite-compulsory-licensing-generic-cancer-drug-too-costly-for-the-poor/

31 Norris, J. & Adelman, C. (2013), Compulsory Licenses under TRIPS: An Analysis of Good Intentions vs. Unintended Consequences to Patients’ Health, Hudson Institute, May 2013, p.6; Nunn, A., Massard da Fonseca, E., Bastos, F. & Gruskin, S. (2009), “AIDS Treatment in Brazil: Impacts and Challenges”, Health Affairs, Vol.28, No.4, pp.1103-1113

32 Bond, E. & Saggi, K. (2012) “Compulsory licensing, price controls, and access to patented foreign products”, Vanderbilt University, April 2012, www.wipo.int/edocs/mdocs/mdocs/en/wipo_ip_econ_ge_4_12/wipo_ip_econ_ge_4_12_ref_saggi.pdf

33 Norris & Adelman (2013), pp.6-734 Torstensson, D. & Pugatch, M. (2010), Keeping Medicines Safe –

A Study of the Regulations Guiding the Approval of Medicines in Emerging Markets, Stockholm Network

35 Newton, P., Green, M. & Fernández, F. (2010), “Impact of poor-quality medicines in the ‘developing’ world”, Trends in Pharmacological Sciences, Vol.31, No.3-3, pp.99-101

36 Bate, R. (2007), “Thai-ing Pharma Down”, Wall Street Journal Asia, 2/9/2007; Lybecker, K. & Fowler, E. (2009), “Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules”, Journal of Law and Medical Ethics, Vol.37, No.2, pp.222-39

37 Izvestia.ru, “Russian medicine translate into global standards in two years”, 2/17/2014, http://izvestia.ru/news/565724 (Translated)

38 Ibid.; Deloitte, Trends and practical aspects of development of the Russian pharmaceutical market – 2013, pp.8, 12

39 Embassy of Switzerland in Russia (2011), “Pharma 2020…” 40 Ibid.41 BIO (2010), “How do Drugs and Biologics Differ?”, 11/10/201042 Embassy of Switzerland in Russia (2011)43 Ibid.44 Pugatch Consilium analysis, Biopharmaceutical

Competitiveness and Investment (BCI) Survey, in partner with PwC, 2013

45 Ibid.46 US National Institutes of Health, www.clinicaltrials.gov 47 Nair, G. (2008), “Impact of TRIPS on Indian Pharmaceutical

Industry”, Journal of Intellectual Property Rights, Vol.13, Sept.2008, pp.432-441

48 UN General Assembly, “Resolution 68/220 adopted by the General Assembly on 20 December 2013”, 68th session, Art.1(f)

49 Ibid.; OECD (2012), Innovation for Development, May 2012, pp.13-14; Pugatch Consilium (2014), Building the Bioeconomy, April 2014

notes


notes

50 Singapore Economic Development Board (EDB) (2014), Biomedical Sciences Singapore The Biopolis of Asia, EDB Singapore

51 EDB (2013), Singapore Biotech Guide 2012/2013, p.1552 Korean Ministry of Health & Welfare (MHW) & Korea Health

Industry Development Institute (KHIDI), Korea Pharmaceutical Industry – Present and Future, p.10; Ministry of Education, Science and Technology, Biotechnology in Korea, www.kribb.re.kr/eng/file/Biotechnology_in_Korea_0905.pdf

53 MHW/KHIDI, Korea Innovative Pharmaceutical Company, p.6, http://khidicis.org/src/imgs/pdf_main/Korea_Innovative_Pharmaceutical_Company.pdf

54 US National Institutes of Health, clinicaltrials.gov55 Joo, H. (with KHIDI), “Global Expansion of Medical Korea”,

Presented at the Russian Pharmaceutical Forum, St. Petersburg, June 2014

56 Cavazos Cepeda, R., Lippoldt, D. and Senft, J. (2010), “Policy Complements to the Strengthening of IPRs in Developing Countries”, OECD Trade Policy Working Papers, No.104, OECD Publishing

57 Branstetter, L., Fisman, R. and Foley, C.F. (2005), Do Stronger Intellectual Property Rights Increase International Technology Transfer? Empirical Evidence from U.S. Firm-Level Panel Data, U.S. Department of Commerce, Bureau of Economic Analysis/NBER

58 Kim, Y., Lee, K., Park, W. and Choo, K. (2012), “Appropriate Intellectual Property Protection and Economic Growth in Countries at Different Levels of Development”, Research Policy, Vol.41, pp.358– 375

59 Branstetter, L., Fisman, R., Foley, C. and Saggi, K. (2011), “Does Intellectual Property Rights Reform Spur Industrial Development?”, Journal of International Economics, Vol.83, Iss.1, pp.27–36

60 Department of Industrial Policy & Promotion (DIPP), “Fact Sheet on Foreign Direct Investment, 2000-2014”, p.2, http://dipp.nic.in/English/Publications/FDI_Statistics/2014/india_FDI_February2014.pdf; Shapiro, R. & Mathur, A. (2014), How India Can Attract More Foreign Direct Investment, Create Jobs, and Increase GDP: The Benefits of Respecting the Intellectual Property Rights of Foreign Pharmaceutical Producers, Sonecon, Jan. 2014, www.sonecon.com/docs/studies/FDI_IP_and_the_Pharmaceutical_Sector_in_India-Shapiro-Mathur-Final-January2014.pdf

61 Ibid.62 FT, “KKR to invest $200m in India pharma group Gland”,

11/28/2013, www.ft.com/intl/cms/s/0/74c390d6-57fb-11e3-82fc-00144feabdc0.html#axzz31Bft8LmJ

63 India Brand Equity Foundation, “Indian Pharmaceutical Industry”, Dec.2013, www.ibef.org/industry/pharmaceutical-india.aspx

64 McGill, A. (2009), “Compulsory licensing of patent pharmaceuticals: Why a WTO administrative body should determine what constitutes a public health crisis under the Doha Declaration”, Wake Forest Intellectual Property Law Journal, Vol.10, No.1, pp.69-97

65 Bird & Cahoy (2008)66 Ibid.67 Pugatch, M., Chu, R., Torstensson, D. & Dayan, A. (2012),

Scientific American Worldview, 2012, pp.85-8768 Singaporean Agency for Science, Technology and Research

(A*STAR) ( 2008 ) National Survey of R&D in Singapore, 2003 – 2008, www.a-star.edu.sg/Portals/0/media/RnD_Survey/RnD_2008.pdf

69 Park (2008), “International patent protection: 1960-2005”, Research Policy, Vol.37, Iss.4, p.763

70 Mexican Secretary of Economy, “Total inward FDI flows by type of investment, originating country, economic sector and destination (1999-2014)”, www.economia.gob.mx/comunidad-negocios/competitividad-normatividad/inversion-extranjera-directa/estadistica-oficial-de-ied-en-mexico

71 Ibid.72 Olivares, “APIs, imports and the Bolar exemption: concerns

and practical measures”, www.olivares.com.mx/En/Knowledge/Articles/RegulatoryLawArticles/APIsimportsandtheBolar exemptionconcernsandpracticalmeasures

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Compulsory liCensing for pharmaCeutiCals in russia Licensing in Russia… · Compulsory Licensing...

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