6 April Pharmaceutical companies: doing business in changing times

Transcription

1 6 Pharmaceutical companies: doing business in changing times

2 Russia: limitations and opportunities Key indicator Value Rank Population 1 (2015) mln 9 Growth rate of population (2014) Life expectancy (2014) Mortality per 1000 (2014) % population age> 65 (2014) % population age 0 14 (2014) GDP growth rate (2015) 0.2% years , % % % n/a 2015 Healthcare expenditures per capita, USD and as share in GDP, % 72 17,4% US Germany France Poland 2015 Average life expectancy, years 79,6 80,6 World Average 10,9% 11,6% ,8 6,5% ,4 9,2% 850 Brazil Russia India China 73,6 6,7% 636 Target for ,0 70,9 4,2% 70 68,1 5,9% ,4 1 Excluding Crimea US Germany France Poland Brazil Russia India China Source: Federal State Statistics Service, CIA, BMI, WHO, analysis

3 Session 1 1. Localization and local product recent developments 2. Public procurements of EDL medicines: status of a sole supplier within investment contracts, will third-oneout law become second out? 3. Price regulation perspectives for EDL medicines 4. Towards the common market of the Eurasian Economic Union: main achievements for Price regulation of medicines in the Eurasian Economic Union - comparative overview 6. Investors and investment regimes: limitations and opportunities 3

4 Localization and local product recent developments 1 4

5 Current status of Pharma 2020 implementation By 2016 the following is achieved: share of local EDL medicines and strategically important medicines 76.8% pharmaceutical factories constructed 25 amount of state support more than 19.5 billion RUB According to Pharma 2020* by 2020 the share of local EDL medicines 90% * Federal target program Development of pharmaceutical and medicine industry for the period until 2020 and further perspective adopted under the Resolution of the Russian Government No. 91 of 17 February

6 Whether you company/group has localised production in Russia? A. Yes, primarily full cycle production of medicines, including production of APIs; 41% B. Yes, primarily full cycle production of medicines, but without production of APIs; C. Yes, primarily full cycle production of medical devices; D. Yes, but generally only primary and (or) secondary packaging; E. No; 9% 21% 24% F. N/A, our company/group is not involved in production in principle. 3% 1% A. B. C. D. E. F. 6

7 Level of localization required for admission to public procurements 2016 was the last year when execution of primary and/or secondary packaging stages was sufficient for admission to public procurements under the Third-oneout law. Starting from 1 January 2017 an access to public procurements may be restricted to foreign EDL medicines, if they are only packaged in the EAEU. till 31 December 2016: EAEU medicine (ST-1) starting from 01 January 2017: EAEU medicine (ST-1) EAEU medicine (ST-1) EAEU medicine (ST-1) foreign medicine packed in the EAEU State customer foreign medicine packed in the EAEU State customer foreign medicine packed outsidethe EAEU foreign medicine packed outside the EAEU 7

8 Changes in concept of locally produced medicines (1/4) Key criterion before 1 January 2017 execution of sufficient processing of a product within the EAEU. generally: Sufficient processing Treaty 2008 * an alteration of classification code of a product under the UPNEEA ** within any of first 4 figures as a result of processing generally: Treaty 2009 *** classification of all foreign materials under different UPNEEA code than a finished medicine value of foreign materials of the same code used in processing shall not exceed 50 % of the EXW price of the finished medicine (ad valorem rule) *Agreement between the Government of Russia, Government of Belarus and Government of Kazakhstan of 25 January 2008 On unified rules for determination of a country of products origin (the Treaty 2008) ** Unified Products Nomenclature of External Economic Activity *** Agreement on rules for determination of a country of products origin in CIS of 20 November 2009 (the Treaty 2009) 8

9 Changes in concept of locally produced medicines (2/4) Amendments to the Resolution No. 719* Under the amended version of the Resolution No. 719, starting from 1 January 2017 medicines are acknowledged to be manufactured in Russia upon fulfillment of the following criteria: 1 2 obtaining of the Russian marketing authorization (registration); and undergoing of all the following technological operations within the EAEU: manufacturing of finished dosage form packaging quality release control Starting from 1 January 2017 execution of primary / secondary packaging is not sufficient for treating medicine as manufactured in Russia * Resolution of the Russian Government No. 744 of 2 August 2016 On Introduction of Amendments to the Resolution of the Russian Government No. 719 of 17 July

10 Changes in concept of locally produced medicines (3/4) Application of the Resolution No. 719 It might be assumed that in practice starting from 1 January 2017 the Resolution No. 719 would be applicable to a determination of medicines origin for public procurements However, formally the rules set under the Resolution No. 719 shall apply to conclusion of SPICs. While a status of medicines for application of restrictions in the sphere of public procurements shall be determined based on customs criteria ( sufficient processing ) set under the Treaty 2009 ( Third one out law, 15% preferences) or the Treaty 2008 (15% preferences) 10

11 Prospective EAEU rules of determining goods origin Under art. 37 (2) of the EAEU Treaty* the Rules for determination of goods origin** have been drafted. Goods are acknowledged as of EAEU origin if: fully produced within EAEU member-state; or undergo sufficient processing in EAEU member state. Currently the draft of the Rules is undergoing regulatory impact assessment The Rules provide criteria very similar to those set under Treaty 2008 Sufficient processing - an alteration of classification code of a product under the Harmonized system *** within any of first 4 figures as a result of processing With that, it is clearly stated that no packaging operation could be considered as sufficient processing. * Treaty On the Eurasian Economic Union of 29 May 2014 ** Rules for determination of origin of goods imported to the customs territory of the EAEU ( *** Harmonized system established under the International Convention on the Harmonized Commodity Description and Coding System of 14 June

12 Public procurements of EDL medicines: status of a sole supplier within investment contracts, will third-one-out law become second out? 2 12

13 Status of a sole supplier due to conclusion of investment contracts (1/2) Starting from 1 September 2016 the Law On Contractual System* prescribes a possibility of obtaining a status of a sole supplier in connection with conclusion of the following contracts: Special Investment Contract ( SPIC ) with the Russian Federation (art of the Law On Contractual System) Public Procurement Contract with Investment Obligations at the regional level ( Contract with Investment Obligations ) (art of the Law On Contractual System) Minimum amount of investment required for assigning status of the sole supplier: 3 billion RUB for SPICs, 1 billion RUB for Contracts with Investment Obligations * Federal Law On Contractual System of Goods, Work and Services Procurement for State and Municipal Needs No. 44-FZ of 5 April 2013 ( the Law on Contractual System ) 13

14 Status of a sole supplier due to conclusion of investment contracts (2/2) Issues for consideration by a potential investor: status of the sole supplier does not guarantee procurement of medicines from the investor no more than 30% of medicines manufactured during a calendar year by the investor may be supplied under a status of the sole supplier assigned due to a SPIC conclusion. Otherwise, the investor may be held liable in amount up to 50% price of the medicines supplied in excess of the above 30% limit status of the sole supplier grants no exclusivity to the investor several manufacturers of medicines may be assigned with the status of the sole supplier with respect to the same medicine Procurement from a sole supplier is a right of a governmental customer, but not its obligation 14

15 Preferences for local producers in procurements under 223-FZ Starting from 1 January 2017, procurement of local goods by the customers falling under the Law 223-FZ* will be prioritised in comparison to the procurement of foreign goods by application of 15% preferences**. The list of goods falling under the restrictions is unlimited and, thus, includes medicines. 15% preferences Competitive tender (or a similar type of procurement) a bid for supply of local goods shall be assessed as having price reduced for 15% from the offered Steps auction (or a similar type of procurement) a contract with a winner for supply of foreign goods shall be concluded with a price offered by the winner «minus» 15% Customers, who conduct procurements in accordance with the Law 223-FZ: State owned companies and their subsidiaries Budgetary foundations (in case of procurements at the expense of their commercial income and in case of some rare exceptions) State and municipal unitary enterprises (after 1 January 2017 only as an exception) * Federal Law On purchases of goods, work, services by separate types of legal entities No. 223-FZ of 18 July 2011 ** According to the Resolution of the Russian Government No. 925 of 16 September

16 Prospective amendments in public procurements (1/2) 1. Second out law Currently, draft of the resolution prescribing additional preferences for medicines, which full circle manufacturing, including creation of API, is localized in Russia is undergoing regulatory impact assessment*. The preferences are supposed to apply as a first step preceding application of the already existing rules on preferential admission of the EAEU medicines to public procurements (i.e. Third-one-out law). Probability of the second out law adoption is rather unclear FAS does not support this initiative since it may limit competition and lead to increase of prices for EDL medicines full cycle manufacturing in Russia (including creation of API) only FDF is processed from foreign API or even less profound stages are localized only FDF is processed from foreign API or even less profound stages are localized State customer * Draft of the regulation 16

17 Do you support the Third-one-out law and how do you feel about the potential adoption of Second out law in light of your company s interests? A. I do not support the Third-one-out law or adoption of the Second out law; B. I appreciate the Third-one-out law but I do not support the Second out law adoption; 64% C. I support both, the Third-one-out and Second out laws. 22% 14% A. B. C. 17

18 Prospective amendments in public procurements (2/2) 2. Description of medicines in procurement documentation Currently, requirements to description of medicines in procurement documentation* are mostly focused on the issues on indication of either international non-proprietary name (INN) or the trade name and generally do not explicitly prohibit specification in the documentation other key characteristics of medicines (though some prohibitions follow from the FAS clarifications). At the same time, Russian Ministry of Healthcare developed a draft** supplementing existing requirements to medicine description. Generally, the draft sets a prohibition to indicate specific forms of medicine, injection form, dosage, type of package and etc. * art. 33 of the Law On Contractual System ** draft of the regulation is published on Potential risks from the respective limitations unified rules of objective description preventing restriction of competition vs potential risk of improper medical care due to complications with procurement of medicines having the required injection form, dosage or other essential characteristics 18

19 Amendments in public procurements of medical devices In April 2016 Third-one-out law* (the Resolution ) applicable to medical devices ( MD ) was supplemented, inter alia: the restriction is not applied if the final bids propose supply of local products created by several manufacturers of the same group**; MD included into the List*** and those not included cannot be covered by the same contract (one lot)***; it is not permitted to replace local (EAEU) MD by foreign or by MD of other manufacturer while performing the contract; in case the restrictions under the Resolution are not applicable, 15 % price preferences may be applicable****. The list of MD covered by the Third-one-out law was materially supplemented * Resolution of the Russian Government No. 102 of 5 February 2015 (as amended by the Resolution of the Russian Government No. 337 of 22 April 2016) ** as defined under art. 9 of the Federal Law On Protection of Competition No. 135-FZ of 26 July 2006 *** the list of certain MD originating from foreign states subject to restriction approved by the Resolution (the List ) **** set under the Order of the Russian Ministry of Economic Development No. 155 of 25 March

20 Price regulation perspectives for EDL medicines 3 20

21 Price regulation perspectives for EDL medicine In December 2016 the Russian Ministry of Healthcare developed a draft Resolution of the Russian Government amending the rules for the registration of the maximum selling prices for EDL medicines*: 1 Clarification for a set of application documents for the price registration of foreign EDL medicines packed in Russia; 4 Possibility to file an application for the reduction of the maximum selling price together with an application for modifications of a register entry; 2 Change of decreasing coefficients for the price registration of generic/ biosimilar medicines depending on the price groups; 5 Exclusion of data from the price register if a medicine is absent in circulation in Russia for 3 years. 3 Change of the industrial site would require new price registration (amendment of par. 6.1 of the Rules for Maintaining the Register of Maximum Selling Prices); *Draft Resolution of the Russian Government On amendments to the Resolution of the Russian Governments No. 865 of 29 October 2010 (

22 Price regulation perspectives for EDL medicines Recently the President has requested to enhance efficiency of pricing regulation for EDL medicines and in particular revise currently applied prices in Russia *. Among the measures covered by the President s request are the following: 1. to adopt rules of economic analysis 4. to compare prices for EDL during the price registration for EDL medicines (including the maximum allowed level of profitability, inter alia, for foreign medicines). 2. to re-register all prices for EDL medicines under the new procedure. 3. to consider the possibility to separate state procurement of EDL medicines from the delivery services; medicines calculated under new rules with the actual selling prices for such EDL medicines applied earlier for supplies to the state customers (in case prices for purchased EDL medicines exceed the newly-set such documentation on procurement shall be transferred to the lawenforcement authorities). * 22

23 Price regulation perspectives for EDL medicines Measures suggested by FAS aimed at reduction of maximum selling prices for medicines*: to compel the marketing authorization holders of foreign-manufactured medicines to revise the registered prices in case of price decrease in the referent countries; to revise prices for generics in case of price decrease for referent medicines; to establish price indexation level dependent on the price group of medicines and to introduce the differentiated reduction index for generics depending on the price group of the referent medicine; to limit a level of profitability for calculation of the prices for referent medicines; to use comparison method (comparison with referent medicines and average sell prices) for price calculation of local EDL medicines instead of cost calculation; to revise the list of reference countries replacing the countries with the highest prices with the countries with the lowest prices; to update the State register of prices for EDL medicines each year keeping only the information of medicines being de facto in circulation. * 23

24 Did your company have to reduce the prices for medicines as a result of the FAS s policy? A. Yes, we have voluntarily reduced prices for certain medicines; 65% B. No, we ignored the FAS s requests; C. Our company was not affected by this story in any way. 24% 11% A. B. C. 24

25 Other amendments 25

26 Overview of other key regulatory amendments of 2016 Enactment of special regulation for biomedical cellular products (Please see the next slide for more details) New rules of marketing authorization reissuance On 1 January 2017 amendments to the Law On Circulation of Medicines came into force, establishing new rules of issuance marketing authorization ( MA ) for an unlimited term and issuance new MA in case of change of data in the registration dossier, in particular: inability to obtain permanent MA for the medicines absent in circulation for 3 years; an obligation to provide GMP certificate issued by the Russian authorities. Adoption of GxP rules Starting from 1 March 2017 GPP (Good Pharmacy Practice) and GTSP (Good Transportation and Storage Practice) are in effect and establish requirements to retail of medicines and their transportation and storage. New requirement for manufacturers of ethanol pharmaceutical ingredients on accounting and declaring Starting form 1 January 2017 manufacturers producing active pharmaceutical ingredients with ethanol ( EPIs ) are obliged to equip the production equipment with automatic means for measuring and accounting concentration and volume of absolute alcohol in EPIs and volume of EPIs; and to ensure transfer of respective information to the Unified State Automated Information System of accounting of production volume and turnover of ethyl alcohol, alcoholic and alcoholcontaining products. Changes in regulation of ST-1 certificates issuance In September 2016 rules of issuance ST-1 certificates were amended as follows: validity period of ST-1 certificate was changed from 6 months to 1 year; experts right to carry out on-site audit of production site was abolished. 26

27 Regulation of biomedical cellular products (BCP) Federal law On Biomedical Cellular Products No. 180-AP of 23 June 2016 came into force on 1 January 2017 (except for separate provisions, which are effective starting from 1 January 2018). It covers the following areas of BCPs circulation: development preclinical and clinical trials examination state registration production quality control sale use storage transportation import and export destruction of BCP donation of biological material (but only for BCP production) Due to inability to register BCP the Law On BCPs was an objective necessity (after 2011 there was no clear legal possibility to register BCPs). BCP medicine or medical product BCP complex, consisting of a cell line(s) and auxiliary substances (may also be combined with medicines or medical products). Cell line a standardized population of cells of the same type with a reproducible cell composition, obtained from the human body with subsequent cultivation of cells outside it. The Law is criticized for: duplication of provisions of the Law on Circulation of Medicines and questionable difference of BCPs from biological medicines; Limited sphere of application - only complexes with cell lines may qualify as BCP while complexes with cell fractions are not regulated; Unlike world practice treating BCPs as derived from both humans and animals, the Law sets human body as the only source of cells. 27

28 Prospective amendments (1/2) 1. Removal of legal obstacles for state registration of medicines produced under a contract manufacturing model in December 2016 Russian Ministry of Industry and Trade proposed to allow state registration of medicines under the same INN* produced by the same manufacturer at one manufacturing site under different trade names; respective draft amendments to the Law On Circulation of Medicines** are undergoing public discussion procedure; currently state registration of such medicines is prohibited by law***. * INN - international nonproprietary name ** Federal Law On Circulation of Medicines No. 61-FZ of 12 April 2010 ( the Law On Circulation of Medicines ) *** Item 6(2) of Article 13 of the Law On Circulation of Medicines 28

29 Prospective amendments (2/2) 2. Potential legitimation of medicines online trade Following long-term discussion among representatives of retail pharma business and state authorities, Ministry of Healthcare has developed draft regulations legitimating online trade of medicines*. Key issues set by the current draft: only those who have offline retail business (i.e. pharmacies) and respective license for distant retail sale of medicines will be entitled to sell medicines online each pharmacy will be allowed to have only 1 web-site (data on which will be included in the Register of websites of pharmacies) sale of both OTC and Rx medicines will be permitted (except for medicines subject to strict record keeping, anabolic medicines and medicines with ethyl alcohol volume percent over 30%) request for Rx medicines purchase shall be accomplished by copy of prescription (authentication of original shall be executed upon delivery) only pharmacists will be authorized to deliver medicines to the customers. * It is expected that in 2017 distance sales of medicines may be permitted 29

30 Amendments with respect to regulation of medical devices Amending the rules of state subsidies provision Rules of providing state subsidies for clinical trials of medical devises are materially revised*. Inter alia, there are the following changes: scope of costs which may be covered by a subsidy is extended; amount of subsidies is increased from RUB 5 mln up to RUB 200 mln; subsidy may cover up to 80% from actual costs instead of 50%. Adopting new list of implantable medical devices The Decree of the Russian Government No r of 22 October 2016 substantially extended the list of implantable medical devices to human bodies under the state programme of free medical care (more than 100 new medical devices were added to the list). Postponing the key milestones of pricing regulations for implantable medical devices Under the Resolution of Russian Government No. 735 of 1 August 2016 the following key milestones of pricing regulation are postponed: submission of application for price registration (15 July 2017), setting level of wholesale markups (1 September 2017), developing/suggesting rules for prices re-registration (1 October 2017). Prolonging validity term of marketing authorizations for medical devices Under the recent amendments marketing authorisations for medical devices issued before 2013 (for an indefinite term) remain valid until 1 January 2021 (instead of previous 1 January 2017). * by the Resolution of the Russian Government No. 37 of 20 January

31 Towards the common market of the Eurasian Economic Union: main achievements for

32 Whether you company/group sells products in other EAEU countries (abroad Russia)? A. Yes; 61% B. No, we perform sales only in Russia, but plan to enter markets of other EAEU countries; C. No, we perform sales only in Russia and do not plan to expand sales to other EAEU countries; D. N/A, we do not sell products even in Russia, we perform other activities. 22% 14% 3% A. B. C. D. 32

33 Key documents regulating EAEU Common Market of Medicines First level acts Treaty on the Eurasian Economic Union (concluded on 29 May 2014) Second level acts General regulations (requirements for registration, examination, labelling of medicines, criteria of OTC medicines, etc.) Third level acts Safety regulations (GLP,GVP) It is planned to adopt around 60 documents in the following years including, guidance: on preparation of CTD on conducting inspection of compliance to GCP and GVP Agreement on Common Principles and Rules of Medicines Circulation in the EAEU (concluded on 23 December 2014) Quality regulations (GMP, GDP, rules of inspections conduction, concept of pharmacopeia harmonization) Effectiveness regulations (GCP, rules of biological medicines research, rules of bio-equivalency) As well, EAEU commission works on development of the unified EAEU pharmacopoeia on validation of manufacturing and processes on choice of trade names for medicines, and etc. 33

34 Key principles of medicines marketing authorization in the EAEU Rules of medicines marketing authorization ( MA )* presume the following way of registration in the EAEU : MA of new medicine EAEU rules Decentralized procedure Mutual recognition procedure Simultaneous MA in referent and in recognizing country (ies) MA in referent country (ies) approx. 210 days approx. 210 days overall MA in recognizing country (ies) approx. 100 days each country Medicine with MA under national rules National rules permissible until 31 December 2020 Bringing MA in compliance with EAEU rules approx. 100 days shall be completed until 31 December 2025 * adopted under the Decision of the EAEU Commission No. 78 dated 3 November 2016 On Rules of Marketing Authorization and Expertise of Medicines for Medical Use 34

35 Key documents regulating EAEU Common Market of MD First level acts 2014 Treaty on the Eurasian Economic Union (concluded on 29 May 2014) Agreement on Common Principles and Rules of Medical Devices Circulation in the EAEU (concluded on 23 December 2014) Second level acts Acts, establishing the requirements to MD, inter alia, in the following areas are already adopted: marketing authorization and examination labelling classification based on potential risks of application general requirements to safety and effectiveness clinical and laboratory trials technical trials monitoring of safety, quality and efficiency etc. Third level acts 2017 The list is not defined yet 35

36 Key principles of MD marketing authorization in the EAEU Rules of medical devices marketing authorization presume the following ways of registration in the EAEU : MA of new MD MD with MA under national rules EAEU rules National rules permissible until 31 December 2021 analogue of decentralized procedure approx. 170 days authorities of Referent Country prepare expert opinion while Recognizing Countries acknowledge it. MA is issued simultaneously for all countries requested for registration * adopted under the Decision of the EAEU Commission No. 46 of 12 February 2016 On Rules of Marketing Authorization and Examination of Medical Devices Safety, Quality and Effectiveness 36

37 Price regulation of medicines in the Eurasian Economic Union - comparative overview 5 37

38 Overview Russia Belarus Kazakhstan Kyrgyzstan Armenia Prices for medicines are regulated by law Yes Yes Yes No, only in draft No, only in perspective Categories of medicines falling under the pricing regulation EDL medicines only all medicines included into GVFMA list procured by the single distributor EDL medicines only Medicines intended for provision with reimbursement from the state Channels of supply falling under the pricing regulation all all currently only state procurement under GVFMA all TBD Currency of price fixing (registration) RUB any currency KZT KGS TBD Possibility of registered price re-registration (increase) once in a year while amending MA once in 6 months upon necessity (no special rules) once in a year Prices in referent countries are considered Yes, for foreign products, inter alia, packed in Russia Yes Yes No Yes 38

39 Investors and investment regimes: opportunities and limitations 6 39

40 Incentives potentially available for investors in Russia Special economic zones Advanced development zones Free port Vladivostok Financial and nonfinancial incentives Federal and regional incentives Designed to develop Russian industry/technology Tax incentives (profits tax, property tax, land tax, social contributions reduced rates) Free customs zone Other non-tax incentives (e.g. access to land and other infrastructure, simplified administrative procedures, simplified migration procedures) Designed for attraction of investments (initially, implementation is planned for Far East region) Tax incentives (profits tax, property tax, land tax, social contributions reduced rates, etc.) Free customs zone Other non-tax incentives (e.g. preferential access to land and other infrastructure, simplified administrative procedures, simplified migration procedures) Designed to develop areas of ports in Far East (including one airport) Tax incentives (profits tax, land tax, property tax, reduced social contributions rates); Free customs zone Other non-tax incentives (e.g. preferential access to land and other infrastructure, simplified administrative procedures, simplified migration procedures) Special investment contract Established to foster the development of manufacturing and innovative sectors of the Russian economy. Tax (mostly profit tax) incentives Non-tax incentives (e.g. stability of regulatory regime, sole supplier status for state tender purposes) Some federal non-tax incentives Subsidies for compensation of expenses related to development of analogues of medicines, manufacturing of medicines, clinical trials Loan financing Others Regional investment projects and regional benefits Tax incentives (profits tax, property tax, land tax, transport tax) Subsidies for compensation of certain expenses Preferential access to land and other infrastructure Informational, administrative, legal and forms of support Incentives differ for various regimes Qualification criteria also differ significantly 40

41 Special investment contract (1 of 2) Special investment contract (SIC) new form of contractual relationships between the state and business aimed at supporting the Russian manufacturers and attracting foreign investments Incentives available grandfather clause stable tax and regulatory regime federal and regional tax concessions (in practice proved to have limited availability in certain cases) sole supplier status for the purpose of state tenders under the Federal Law No. 44-FZ, but not sole in fact (also, goods manufactured under SIC are not automatically treated as made in Russia ) regional non-tax concessions (e.g. support with infrastructure) It is possible to extend SIC to existing project, but negotiations with the state are required Possibility to negotiate other incentives is very limited Possibility to fix eligibility for future incentives is very limited It is possible to negotiate with the state termination ( exit ) and liability terms, but subject to certain limitations (also, state insists on introduction of new penalties) 41

42 Special investment contract (2 of 2) Conclusion of SIC is not an easy exercise SIC is still a new tool (e.g. regional legislation is not very well developed) It should not be expected that a special investment contract would be granted if all statutory criteria are satisfied by the investor An investor shall be able to sell its project to the state to succeed, which is not easy unless this is a landmark project for the Russian economy Satisfaction of minimum possible requirements is unlikely to be sufficient for this purpose Different authorities may have different views It should be expected that the procedure will take the maximum timing as provided by the laws or even longer 42

43 Thank you! Andrey Odabashian Senior Associate, Legal Head of Group on rendering legal services to pharma companies +7 (812) , ext Artur Oganesyan Senior Associate, Legal Commercial and Anti-trust Group +7 (495) Maria Nevzorova Associate, Legal Group on rendering legal services to pharma companies +7 (812) , ext Aleksandra Morozova Associate, Legal Group on rendering legal services to pharma companies +7 (812) ext This publication has been prepared for general guidance on matters of interest only, and does not constitute professional advice. You should not act upon the information contained in this publication without obtaining specific professional advice. No representation or warranty (express or implied) is given as to the accuracy or completeness of the information contained in this publication, and, to the extent permitted by law, companies of network, their members, employees and agents do not accept or assume any liability, responsibility or duty of care for any consequences of you or anyone else acting, or refraining to act, in reliance on the information contained in this publication or for any decision based on it. refers to Legal, or, as the context requires, other member firms of PricewaterhouseCoopers International Limited, each of which is a separate legal entity Legal. All rights reserved.