The past year s key changes in the regulation of the pharma industry

Transcription

1 The past year s key changes in the regulation of the pharma industry Andrey Odabashian, Senior Associate Maria Nevzorova, Associate

2 Agenda Key changes in pharmaceutical regulations 1. Import substitution and support of local manufacturers (SPICs, subsidies and restriction in the area of public procurements, concept of a local manufacturer) 2. Key changes in price regulation for EDL medicines 3. Other amendments 4. Prospective developments Key changes in regulation of medical devices 1. Subsidies 2. Restriction in the area of public procurements ( third one out law ) 3. Introduction of price regulation for medical devices implantable to human bodies 2

3 Key changes in pharmaceutical regulations 3

4 Import substitution and support of local manufacturers: overview One of the key trends in the Russian regulatory framework, is support of local manufacturers (inter alia, of medicines) and limitation of access to the market for foreign companies Support special investment contracts (SPICs) state subsidies financial support from state foundations for development of a production sector price preferences for EDL medicines of EAEU origin Limitations restriction of access to public procurements for foreign medicines application of 15% reduction index to price of foreign medicines 4

5 Import substitution and support of local manufacturers: provision of subsidies to Russian manufacturers of API Maximum amount of a subsidy* mln RUB that may cover up to 50% of the actual expenses under the project Costs that may be compensated by a subsidy: financial lease of equipment; start-up activities with respect to equipment; purchase of raw materials for start-up activities; other costs (up to 10%). 1,454,032.5 k RUB - a budget set for 2016 for granting subsidies compensating expenses on - localization of medicines and (or) APIs production in Russia ** Key requirements for a subsidy provision there is no other local production of a similar medicine as of a date of an application; a business plan provides a 5-fold amount of revenue in a 3 year period after commercial launch of a medicine; no other budget funding is provided under a project; etc. * According to the Resolution of the Russian Government No of 1 October 2015 ** According to the Federal Law On Federal Budget for 2016 No. 359-FZ of 14 December 2015 In addition, subsidies for the development of new products may be provided under the Resolutions of the Russian Government No of 1 October 2015 and No of 30 December

6 Import substitution and support of local manufacturers: financial support from state foundations for development of a production sector State foundations (established on federal or regional level) provide financial support to legal entities engaged in the production sector in any legal way, including, inter alia, provision of: loans; grants; contributions into charter capital; financial lease milliards RUB - total amount of loans provided by one of the foundations - Foundation on Development of Production Sector coordinated by Minpromtorg, for support of projects in pharma-bio-medical sector * According to the information published on the official website of Foundation on Development of Production Sector coordinated by Minpromtorg 6

7 Import substitution and support of local manufacturers: restriction of access to public procurements ( third one out law ) An access of foreign medicines to public procurements is restricted* if there are 2 or more bids for supply of similar medicines (in terms of International Nonproprietary Name) of EAEU** origin, which origin is confirmed by ST-1 certificate. Special transitional period till 31 December 2016: an access to public procurements is not restricted to foreign medicines, which primary and/or secondary packaging and release quality control are performed in the EAEU. Procurement No. 1 EAEU medicine (ST-1) EAEU medicine (ST- 1) foreign medicine State customer Procurement No. 2 EAEU medicine (no ST- 1) EAEU medicine (no ST- 1) or (ST- 1) foreign medicine * Under the Resolution of the Russian Government No of 30 November 2015 ** Eurasian Economic Union 7

8 Import substitution and support of local manufacturers: application of 15% reduction index to price of foreign medicines 15% preferences for EAEU manufacturers* Starting from 10 May 2015 this preference is established for indefinite term (under the previous version of the Order it was effective till 31 December 2015) In case a winner of an auction in electronic form ** has submitted an application for supply of products of foreign origin, a contract with him shall be concluded with a price offered by the winner «minus» 15% Its shall be applicable in case a foreign medicine is admitted to public procurements (if third one out law is not applicable). An origin of medicine shall be confirmed by a written declaration submitted by a participant of the tender. * Under the Order of the Ministry of Economic Development No. 155 of 25 March 2014 On conditions for access of goods originated from foreign states for state and municipal public procurements of goods, work and services ** Generally a tender for supply of pharmaceuticals shall be conducted only as an auction in electronic form (Resolution of the Russian Government No. 471-r of 21 March 2016). 8

9 Import substitution and support of local manufacturers: concept of local manufacturer - overview of the regulations Current regulation Execution of sufficient processing of a product within EAEU Treaty 2008 * Treaty 2009 *** generally, an alteration of classification code of a product under the UPNEEA ** within any of first 4 figures as a result of processing generally: classification of all foreign materials under different UPNEEA code than a finished medicine value of the materials of the same code used in processing shall not exceed 50 % of the EXW price of the finished medicine (ad valorem rule) Prospective developments Draft resolution **** Localization of particular manufacturing stages EAEU rules It is possible to expect that in future the new rules may be developed under article 37 (2) of the Treaty on the Eurasian Economic Union *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 ** Unified Products Nomenclature of External Economic Activity *** Agreement on rules for determination of a country of products origin in CIS of 20 November 2009 **** Draft Resolution of the Russian Government on amending the Resolution No. 719 of 17 July

10 Import substitution and support of local manufacturers: pricing preferences Overall, the effective price regulations on EDL medicines provide more possibility to register / reregister higher prices if a full-cycle production is conducted in Russia or in other countries of EAEU as compared to a situation where products are entirely produced abroad or only packed in Russia EAEU manufacturers, generally, are not obliged to compare prices for the medicines with the minimum prices applicable in reference countries As opposite, foreign manufacturers and those, who intend to carry out only primary and (or) secondary packaging in Russia, shall provide the information on minimal selling prices in reference countries (such minimal price can not be exceeded) Much wider possibilities to re-register prices are granted to EAEU manufacturers There is no possibility to re-register prices of a foreign manufacturer in connection with the change of prices on raw and other materials, as well as with amendment of out-of-pocket expenses. Moreover, the possibility of the re-registration for foreign manufacturers is rather limited in principle and it may be applied only in a small number of cases. 10

11 Question for voting 1 How the described measures in support of the manufacturing localisation (SPICs, subsidies, financing, price preferences and limitations for public procurements) have affected a strategy of your company? 1. our company has decided to localise/expand the production in Russia / other EAEU country due to these measures; 2. the supportive measures have no effect on our strategy. Our company plans to localise/expand the production in Russia/other EAEU country due to other reasons; 3. the supportive measures have no effect on our strategy. We do not plan the localisation/expansion of the production in Russia/other EAEU country; 4. this question is not applicable to our company (we are not a multinational company or are not involved in production activities). 52% 21% 15% 12%

12 Key changes in price regulation for EDL medicines: overview Starting from October 2015 maximum selling prices for EDL medicines are registered (re-registered) under new rules established by the Resolution of the Russian Government No. 979 of 15 September Submission of documents by a MAH; Almost equal rights of Russian manufacturers and manufacturers from other countries of the EAEU; 5 Maximum selling prices for generic/ bioanalogous medicine shall not exceed 80%/90% of average registered price of referent medicine/ of top registered price for similar medicine. Introduction of 5% reduction index for generic/bio-analogous medicines for foreign manufacturers; 3 Possibility of and rules for the reregistration of the maximum selling prices for EDL pharmaceuticals of foreign manufacturers; 6 Possibility for cancellation of the price registration for EDL medicines if submitted information proves to be inaccurate; 4 Amendments into the rules for the reregistration of the maximum selling prices of local manufacturers; Limitation of a possibility for a repeated price registration at the level higher than 7 the previously registered. 12

13 Changes in price regulation: implications due to a change of a manufacturing site Based on art. 6(1) of the rules and latest clarifications of FAS new price cannot be registered if under the same marketing authorization a new manufacturing site was added Based on FAS s practice, this rule applies regardless of the fact how the production chain has changed: change of local production sites within the EAEU; such change within non-eaeu countries; transfer of packaging stages from abroad to a production site located in the EAEU Whether the similar? approach shall be applied if more profound manufacturing stages are transferred to the EAEU 13

14 Question for voting 2 Which algorithm for calculation of a registered price on EDL medicine was applied by your company after 1 January 2016, if your company / contract manufacturer performs only a primary / secondary packaging and release quality control of an EDL medicine in Russia / other EAEU country? 1. based on the rules for EAEU manufacturers; 2. based on the rules for foreign manufacturers; 3. based on item 6(1) of the Rules for maintenance of the state register of maximum selling prices on EDL medicines (introduction of amendments into an old registered price, without registration of a new price) (in presence of respective earlier registered price) 4. this question is not applicable to our company (we have not applied for the price registration in the mentioned circumstances). 72% 13% 15% 0%

15 Question for voting 3 How do you evaluate a registered EDL price(s), if you applied for its registration/re-registration under new rules (effective starting from 1 October 2015)? 45% 1. the registered price is economically reasonable and meets our expectations; 2. the registered price is unreasonably lower than expected given an amount of our expenses; 3. we have not applied for registration/reregistration of maximum selling price after 1 October % 32%

16 Other amendments In sphere of price regulation: new procedure of agreeing maximum retail and wholesale mark-ups for selling prices on EDL medicines imposing on executive bodies an obligation to coordinate such mark-ups with FAS was set by z the Resolution of the Russian Government No. 58 of 3 February 2016 form of a protocol on prices reconciliation for EDL medicines was amended. Currently applicable form presumes filling data on price of EDL medicine during whole chain of suppliers (but not only the last one as earlier) In sphere of medicines registration: starting from 01 January 2016 a registration dossier for a medicine shall be provided in a form of a common technical document a document confirming a compliance of a manufacturer with GMP rules shall be provided for a medicine s registration (confirmation of registration) 16

17 Prospective developments The following amendments in the sphere of price setting are planned in the nearest future: New rules of maximum selling prices (re-)registration FAS criticizes the effective registration rules and declares that soon new price regulations with respect to maximum selling prices of EDL medicines shall be developed Implementation of pricing measures in order to prevent the closure of the production business of Russian EDL medicines of lower price segment** New methodology of setting maximum mark-ups on retail and wholesale prices for EDL medicines according to the Plan of FAS s activities for the period up to 2018 *, an act on new methodology of setting maximum retail and wholesale mark-ups to EDL medicines shall be enacted in II quarter 2017 * ** List of the President s instructions to the Government on additional measures for the development of the pharmaceutical industry in the Russian Federation (Pr-226, p.6) 17

18 Key changes in regulation of medical devices 18

19 Subsidies Maximum amount of a subsidy* mln RUB that may generally cover up to 50% of the actual expenses under the project Costs that may be compensated by a subsidy: financial lease of equipment; start-up activities with respect to equipment; lease of production premises; purchase of raw materials for start-up activities; interest under bank loans; etc. * According to the Resolution of the Russian Government No of 1 October 2015 ** According to the Federal Law On Federal Budget for 2016 No. 359-FZ of 14 December ,650,414.5 k RUB - a budget set for 2016 for granting subsidies compensating expenses on - localization of medical devices production in Russia ** Key requirements for a subsidy provision aggregate revenue from sale of own medical devices for no less than 100 mln RUB; a business plan provides a 3-fold amount of revenue in a 3 year period after commercial launch of a medical device; no other budget funding is provided under a project; etc. In addition, subsidies for the development of new products may be provided under the Resolution of the Russian Government No of 1 October

20 Restriction in the area of public procurements ( third one out law ) An access of foreign medical devices ( MD ) to public procurements is restricted if there are 2 or more bids for supply of MD of EAEU origin that comply with the procurement documentation and origin of which is confirmed by ST-1 certificate * MD that fall under the restriction include, inter alia: glucose analysers, devices for blood transfusion, several types of reagents for laboratory investigations, refrigerators for medicines, several types of tomographs, electrocardiographs, syringes, and other Minpromtorg plans to supplement the list by including, inter alia, the following MD: dressing materials, prostheses, defibrillators, infant incubators, and other * Resolution of the Russian Government No. 102 of 5 February

21 Introduction of price regulation for medical devices implantable to human bodies Under the recent amendments maximum selling prices for certain MD shall be registered by Rosdravnadzor * Price regulation is applicable only to MD included into the list of MD implantable to a human body under the state programme of free medical care Unlike respective regulation of medicines, maximum selling prices for MD depend on average selling (import) prices of whole group of MD (under a nomenclature classification of MD) under which such MD falls. Manufacturers of MD shall provide to Roszdravnadzor such data on actual selling (import) prices. Price regulation is intended to control supply prices of MD only under the public procurements. Initial (maximal) price of a contract can not exceed the maximum registered price for respective MD. Such average selling (import) prices are calculated not by respective manufacturers, but by Roszdravnadzor in coordination with FAS * Resolution of Russian Government No of 30 December

22 Contacts Andrey Odabashian Senior Associate Head of Group on rendering legal services to pharmaceutical companies +7 (495) , ext Maria Nevzorova Associate Group on rendering legal services to pharmaceutical companies +7 (495) , 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, Russia, its 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 Russia. All rights reserved. Not for further distribution without the permission of Russia. " Russia" refers to IL member-firms operating in Russia. "" is the brand under which member firms of PricewaterhouseCoopers International Limited (IL) operate and provide services. Together, these firms form the network. Each firm in the network is a separate legal entity and does not act as agent of IL or any other member firm. IL does not provide any services to clients. IL is not responsible or liable for the acts or omissions of any of its member firms nor can it control the exercise of their professional judgment or bind them in any way.