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1、Q3 2011 pharmaceuticals +8.8% in local currency terms and +12.1% in US dollar terms. Short-term forecast unchanged from Q211. ? Healthcare: RUB2,324,bn (US$76.51bn) in 2010 to RUB2,552bn (US$86.57bn) in 2011; +9.8% in local currency terms and +13.1% in US dollar terms. Forecast unchanged from Q211.
2、 ? Medical devices: RUB156.7bn (US$5.16bn) in 2010 to RUB175.3bn (US$5.945bn) in 2011; +11.9% in local currency terms and +15.2% in US dollar terms. Forecast down moderately from Q211 due to analyst modification. Business Environment Rating: In the BMI Business Environment Ratings for the 20 markets
3、 of emerging Europe, Russia receives a composite pharmaceutical rating of 57.5 unchanged since the previous quarter, but placing the country fifth overall, one place higher as a result of downgrade in our outlook for Turkey. Russia still has the highest score of any Commonwealth of Independent State
4、s (CIS) market. Key Trends the later rapid decline and consolidation of local industry; and strong growth in 2005 and 2006 driven in large part by massive, over-budget spending under the Provision of Supplemental Medicines or DLO scheme. This has now been sharply cut back. DLO spending rose again in
5、 2008, but there was clear statement of intent from the government that local producers will benefit in the future. The currency devaluation and rapid slip into recession in 2009 were another shock for the market, albeit one that appeared to have passed by the end of 2010. Going forward, the new man
6、datory medicines insurance programme, now slated for 2013, promises both opportunities as well as potential further volatility if it is implemented badly. Russias pharmaceutical market was worth RUB544.3n (US$17.92bn) at consumer prices in 2010. BMIs numbers translate into per-capita expenditure of
7、just US$126 in 2010. Per-capita spending levels are still among the lowest in the CEE region although higher than large markets such as Romania and Ukraine and substantially higher than other, smaller ex-Soviet states. Drug spending was equal to about 1.21% of GDP during the year, which is also low
8、for the CEE region. Pharmaceutical Market By Sub-Sector (US$bn) 2010 Source: Association of International Pharmaceutical Manufactures in Russia (AIPM),AESGP, IMS Health, RMBCB, Remedium, BMI Russia Pharmaceuticals and Healthcare Report Q3 2011 Business Monitor International Ltd Page 14 According to
9、opinion-poll data, Russians are broadly dissatisfied with the level of healthcare provision provided by the state. A survey by the Yuri Levada Centre in August 2008 found that just 18% of Russians were satisfied with current levels of healthcare. Some 60% were dissatisfied, while 30% said they could
10、 obtain good medical services for themselves or their families if required. Medical workers are similarly dissatisfied with conditions, as low pay, poor working conditions and a loss of prestige since Soviet times has led to a shortfall of 46,000 doctors, according to government figures published in
11、 March 2009. In April 2010, the Ministry of Healthcare and Social Development reported that there was a 33% shortfall of medical workers in Russia. OTC medicines represent a characteristically large component of Russian drug market consumption, equal to 37.8% in 2010, while prescription drugs repres
12、ent the remainder, In volume terms, consumption consists overwhelmingly of low-cost generics, and in value terms generic drugs represent around 37% of the market, if OTC products are excluded, and 59% of prescription pharmaceuticals. The market is heavily reliant on imports, accounting for at least
13、75% of the market in value terms and over 90% in the DLO market. One apparent exception is vaccines, with the government claiming that 90% of vaccines on the national schedule are domestically-produced, although many are made using outdated techniques. At present, non-domestic sales for Russian-made
14、 vaccines are modest, and outdated technologies weaken the countrys export potential. In 2010, just RUB184mn (US$6.06mn) of vaccines were exported. The Ministry of Industry and Trade received approval of its industry strategy, the Conception for the Development of the Russian Pharmaceutical Industry
15、 to 2020 (known as Pharma-2020), in October 2009. In October 2010 the government issued a decree (#1660) adopting the 2020 Strategy as official policy and making it a Federal Target Programme, giving it a standalone budget and priority status. The strategy reflects familiar themes in government stat
16、ements regarding the need to stimulate production of advanced generics and patented pharmaceuticals. Its sheer ambition and targets reflect the current government and presidential administrations approach to industrial policy an approach that has yet to be met by clear success on the ground in most
17、areas. In a linked development, in November 2008 Prime Minister Putin announced the formation of a State Council for the Development of the Pharmaceutical and Medical Industries, consisting of representatives from the government, state-owned firms and the private sector. The government has committed
18、 to invest up to US$5.675bn in good manufacturing practice (GMP)-compliant production facilities as well as research and development. Outside investment in large projects, such as the St Petersburg pharmaceutical cluster is also integral to the project, with Novartiss five-year, US$500mn investment,
19、 announced in December 2010, setting an important precedent. Also, the Russian Venture Company announced in February 2011 the creation of a Biopharmaceutical Fund to attract foreign investment to the pharmaceutical industry. Russia Pharmaceuticals and Healthcare Report Q3 2011 Business Monitor Inter
20、national Ltd Page 15 By the end of the next decade, the government wants the market share of locally produced pharmaceuticals to reach 50%. Less plausibly, it says 80% of all drugs sold should be patented pharmaceuticals. The margins on prices are to be minimal. Helping improve the production facili
21、ties of local companies to harmonise them with international standards also appears to be part of the strategy. Most importantly, if the industry is to achieve a high level of import substitution and pursue innovative drug development, the government will need to open up its networks of state-contro
22、lled scientific institutes, known by the acronym NII, to greater private sector cooperation. The Federal Agency for Control over Healthcare and Social Development (Roszdravnadzor), reported that 528 domestic companies were licensed to produce pharmaceuticals at of the end of 2008. Most are generally
23、 small and unprofitable, although around 10 large firms are emerging that are profitable and increasingly well capitalised, and total production levels have risen in Russia in recent years (with the exception of 2009) despite the surge in imports. The government has repeatedly delayed enforcing GMP
24、guidelines in the domestic industry, given the manifest inability of most local players to finance the necessary investment. In March 2010 the government imposed a new deadline of 2014 for GMP compliance a deadline enshrined in the new Law on Medicines that came into force in September 2010. In July
25、 2009 the government announced the opening of a training centre, developed in consultation with US drugmaker Eli Lilly, to help local companies. Around 60 domestic manufacturers reportedly had some GMP-compliant production lines at the end of 2008 and the government said that 30 companies were judge
26、d to be compliant as of the beginning of 2010. Notably, Minister of Health Tatyana Golikova said in May 2010 that domestic industry readiness would not dictate GMP-compliance deadlines. Realistically, the government may adopt the solution put forward recently in Ukraine, namely to apply GMP complian
27、ce to new pharmaceutical production licence applications as well as renewals for existing facilities. The Association of Russian Pharmaceutical Manufacturers (ARFP) represents companies which are compliant or implementing compliance. Consolidation in the domestic pharmaceutical industry is picking u
28、p, but has been slower than expected, in part because regional manufacturers have been sheltered from acquisition by regional government and business interests. The biggest impediment however is that producers are usually unwilling to shoulder huge modernisation costs for grey-field facilities, and
29、it often proves cheaper and more effective to build new plants. If the government is serious about its commitment to enforce GMP requirements by 2014 and comes through with pledged aid, this could re-energise the consolidation process as many of the countrys smaller 500 or so manufacturers will be u
30、nable to pay to convert facilities. In any case, many, perhaps most, smaller facilities will have to close. Russia Pharmaceuticals and Healthcare Report Q3 2011 Business Monitor International Ltd Page 16 Multinationals have usually preferred to import drugs, due to the difficult regulatory environme
31、nt, although the increasing role of the state in purchasing is shifting more manufacturing into Russia due to discriminatory policies favouring locally produced drugs. Low-cost manufacturing has encouraged some investment in production; notably, Krka opened a dosage forms production facility in 2003
32、 outside the capital, Moscow, representing an investment of US$45mn and is reportedly planning further investments of around EUR135mn. Meanwhile, Serbia-based Hemofarm acquired in 2006 by German generics maker Stada opened a large facility in Obninsk, Kaluga, in the same year. Polish company Bioton
33、invested around US$35mn in building an insulin production plant in the Orlov region, which was acquired by Sanofi-Aventis in Q409. Another drugmaker from the country, Polpharma, acquired local generics producer Akrikhin in a deal completed in May 2007. Frances Servier opened a tablet manufacturing f
34、acility in Moscow in late 2008. Russia Pharmaceuticals and Healthcare Report Q3 2011 Business Monitor International Ltd Page 17 Regulatory Regime The main health regulatory agency in Russia is Roszdravnadzor, under the Ministry of Healthcare and Social Development, which replaced the previous Minist
35、ry of Health as part of wide-ranging ministerial and agency restructuring in 2004. The basis for market regulation is the 1998 Pharmaceutical Products Act, which has been amended on several occasions since its introduction, and the Law on Medicines. Among other things, Roszdravnadzor oversees the ma
36、rket authorisation process for medicines, regulates the prices of pharmaceuticals at a national level, as well as determines eligibility for reimbursement. The new federal law On Circulation of Medicines of April 12 2010, Number 61-FZ, entered into force on September 1 2010. It was later amended by
37、the following federal laws; July 27 2010, Number 192 FZ; October 11 2010, Number 271-FZ; and November 27 2010, Number 313-FZ. The legislative set introduced changes in the sphere of government control over medicines prices and the organisation of the medicine distribution system. The law introduced
38、the notion of liability for violating the legal requirements concerning distribution. As well as legislation relating to the licensing of medicines, clinical trials and the accreditation of medical organisations participating in clinical trials. The law introduced new regulations for the withdrawal
39、and destruction of low-grade, falsified and counterfeit medicines, as well as guarantees for access to medicines for the rural population. The regulation set-up a state pharmacopoeia, and it introduced legislation relating to the import and export of medicine, as well quality control and labeling. T
40、he law also introduced changes to the essential medicines list. The new legislation was dubbed as a new phase of pharmaceuticals and medicines regulation in Russia and has several benefits for both foreign and domestic pharmaceutical firms operating in the country.BMI considers the new law, which ha
41、s been adopted in accordance with the Development Strategy For The Russian Pharmaceutical Industry 2020, to be significantly more favourable to domestic firms. The circulation of medicines law focuses on setting up a precise and transparent process for registering medicines, with a detailed descript
42、ion of all the requirements for the state approval of drugs and the actual registration procedure. According to Tatyana Golikova, head of the Health and Social Development ministry, the new drug registration system is strictly regulated in steps and timeframes, with the longest registration time for
43、 new drugs to be 210 business days, equivalent to around 10 months, compared with 18 months or more in previous years. Under the new law, the current practice of open-ended registration certificates for pharmaceuticals will end, with approvals limited to a validity period of five years for a first r
44、egistration. An open-ended registration certificate may be issued in the event of a subsequent successful state re-registration. Notably, medicines designated exclusively for export will not be subject to state approval. Russia Pharmaceuticals and Healthcare Report Q3 2011 Business Monitor Internati
45、onal Ltd Page 18 The federal law also clarifies clinical trial regulation, including mandatory life and health insurance for patients participating in clinical studies. The law establishes the requirement for clinical trials to only be held in accredited medical institutions, which will have to meet
46、 Good Clinical Practice (GCP) standards and strengthens the qualification requirements for researchers responsible for the studies. BMI notes the new legislation maintains that imported medicines are still required to undergo a second round of local clinical trials. This will continue to hamper fore
47、ign pharmaceutical manufacturers aiming to enter the Russian market. However, there are a limited number of exceptions. If the clinical trials are held outside of Russia, but fall under the international clinical trials mutual recognition treaties and/or the reciprocity principle, or if the foreign
48、manufacturer included Russia in the international multicentric clinical trials, then the drug will be accepted. While the amendments to clinical trial regulations are encouraging, it is still alleged that Russian legislation on clinical trials is not in line with international rules and in particula
49、r does not correspond to international principles of patient care. Due to the recent legislative progress, a treaty for the mutual recognition of Russian and EU clinical trial data seems closer than ever to actuality, following a meeting in Brussels between the EU Health Commissioner John Dalli and Russian Health Minister Tatyana Golikova in February 2011. They discussed ways combat non-infectious and infectious diseases and approached a solution to prevalent issues in the sphere of clinical research, relating