Life Sciences Opportunities in Brazil
Presenters - Samuel Weston, Life Sciences Organisartion (DIT) Manager for Latin America - Danilo Santos, DIT Business Development Manager for Brazil - Gareth Moore, Santander Desk Director – South America
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Department for International Trade
Life Sciences Opportunities in Brazil October 2018
Department for International Trade
• Formed in July 2016 following the EU Referendum • Responsible for promoting British trade and investment globally
• Building the UK’s new Trade Policy in preparation for EU Exit
Life Sciences Organisation (LSO)
• LSO selling life sciences in Britain: • Supporting British companies and foreign companies in the UK to export • Supporting foreign companies to invest and grow in the UK
Priority Markets • DIT prioritises its support in countries and regions where the most value can be added • DIT Life Sciences currently have 8 priority markets for investment and 7 for exports
Latin America • Latin America is one of DIT’s priority markets for Life Sciences • 6 countries: Brazil, Mexico, Peru, Colombia, Panama and Cuba • DIT has assisted with deals totalling over £50m during this Financial Year so far • Wide range of companies supported of varying size including global pharma and SME medtech
DIT in Latin America Dedicated staff working on life sciences in the following markets: Brazil Mexico Peru Colombia Panama Cuba In addition, DIT has trade-focussed staff in these markets: Argentina, Barbados, Chile, Costa Rica, Dominican Republic, Ecuador, Guyana, Jamaica, Trinidad and Tobago, Venezuela.
UK Export Finance (UKEF) • UK’s export credit agency (ECA) • Mission is to ensure that no viable UK export fails for lack of finance or insurance from the private sector • Help UK exporters by - providing attractive financing terms - supporting working capital loans - insuring against buyer default • No minimum nor maximum contract value
LSO contacts
Samuel Weston Email: samuel.weston@trade.gov.uk 0207 215 1892 Amy Lambert Email: amy.lambert@trade.gov.uk 0207 215 1960
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Brazil: Country Overview • • • • •
5th largest country in the world 9th largest economy in the world Language: Portuguese Capital city: Brasilia Population of over 200 Million – the world’s 06th most populous country • Divided into 5 regions and 27 states
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Why Brazil? Why now? • Emerging middle class • Largest market in Latin America for medical devices and pharmaceuticals • Nearly 4.000 manufacturers and 10.400 distributors • Favorable demographic conditions • Increasing elderly population • Government initiatives attracting investments – PDPs, PPPs • Approximately 6.500 hospitals and 18.000 diagnostic laboratories
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Healthcare in Brazil – Ageing Population
Institute for Health Metrics and Evaluation (IHME), 2018
Healthcare in Brazil – Epidemiological Profile
Institute for Health Metrics and Evaluation (IHME), 2018 15
Healthcare in Brazil – Epidemiological Profile
Institute for Health Metrics and Evaluation (IHME), 2018 16
Healthcare in Brazil - Expenditure
• Market worth USD196.1bn in 2017 Forecasts: USD 229bn (2022) and USD 273.2bn (2027) growth rate of 7.0% • Healthcare per capita spending USD 937 1,227 (2027) • Total healthcare expenditure as a percentage of GDP was 8.9% in 2017 • Private healthcare spending accounted for 55.6% of total healthcare spending in 2017 Fitch Solutions, 2018 17
Healthcare in Brazil - Expenditure
Institute for Health Metrics and Evaluation (IHME), 2018
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Medical Devices Market
Medical Products Market
ABIMED, 2017
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Domestic Manufacturers Medical devices companies profile
Export.gov; ABIMED, 2017
Medical Products Market 2017 Total Imports of Medical Equipment into Brazil ABIIS Group of Products Orthesis, prosthesis and Special Materials (OPSM) Equipment and Support Materials for OPSM Reagents for In Vitro Diagnostics (IVD) Materials and Equipment for IVD (except IT) Other Medical Equipment including Laser Imaging Diagnostic Equipment and supplies Laboratory Equipment Dental Material and Equipment Materials and Supplies Furniture Other IT for IVD
Imports US$ m
Variation from 2016
312
-4 %
1,061
3%
3,951
22 %
2,040
-16 %
817
-2.4 %
463
4.9 %
906
-3.9 %
113
30 %
951 37 2,143
13.1 % 26.8 % 13 %
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Pharmaceutical Market
Pharmaceutical Market Brazil is the largest pharmaceutic market in LATAM and 07th in the world
Pharmaceutical sales reached ÂŁ15.7 billion (11.4% of total healthcare expenditure) in 2017
In 2017, Brazil imported US$ 6.5b in medicines and raw materials and is expected to reach US$ 6.6b in imports by the end of 2018
Continued high growth of the sector for the next 20 years – between 10% and 20%/year
Sindusfarma, 2017 24
Pharmaceutical Market
Therapeutic Focus • • • • • • • •
Cardiovascular Oncology CNS Respiratory Orthopedics Neuropsychiatric Pain Management Women’s Health
Opportunities for innovative drugs, raw ingredients, and equipment: Therapeutic Focus
- Licensing - Distribution - R&D Services (incremental innovation, drug delivery systems, CMO) - Clinical Trial Services (multicentre studies)
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Pharmaceutical Market – other opportunities - Unlicensed medicine – judicialisation process During 2016, the Ministry of Health spent BRL 654,9 million to attend a demand of 1231 patients for the following medicaments: - Ecilizumab; Estimated annual cost per patient (a/p): BRL 1,16 million - Elosulfase; a/p: BRL 1 million - Galsulfase; a/p: BRL 1.15 million - Atalureno: a/p: BRL 1.3 million - Lomitapida; a/p: BRL 1.4 million - Idursulfase; a/p: BRL 1.18 million - C1 Esterase Inhibitor; a/p: BRL 1.1 million - Alfaglicosidase; a/p: BRL 940k - Metreleptina; a/p: BRL 560k
- PDP (Productive Development Partnership) - Nutrition and supplements (USD 220m in 2017)
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Useful Info
Useful Info Labelling /Marketing Requirements Labels must be in Portuguese. For nutritional supplements/herbs/vitamins, companies must follow specific guidelines to make certain claims. Products marketed with therapeutic effects are considered drugs and must provide efficacy and safety tests.
Limitations on Selling Products and Services Healthcare products must follow regulations established by ANVISA. While certain low risk products may be exempt of registration, it is mandatory to have an importer or distributor for product liability. Foreign companies should have local technical staff and replacement parts for customer support.
Selling to the Government The MOH is the main buyer of healthcare products to supply the public healthcare system. Foreign companies can participate in bids as long they have local representatives, with some exceptions.
Distribution & Sales Channels Companies should establish partnerships to cover the most important regions. Large distributors in both medical equipment and drugstores are likely to prefer products that are already available in the market. Regulations prohibit sales of medicines and medical devices outside of specialized medical stores or pharmacies.
E-Commerce E-commerce is a growing channel for end-users to acquire imported products, if they are for personal use. To reduce returns, sellers should inform customers that Brazilian Customs charges fees to clear imported goods. With regards to products for sales, professional treatment or diagnostic use, importers 28 should follow the regular commercial procedures for importation.
Regulatory Overview
ANVISA •
Brazilian National Health Surveillance Agency (based in Brasília)
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Protects and promotes public health, by exercising health surveillance over products and services
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Health control of ports, airports and borders
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Administrative independence and financial autonomy
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Subject to the Ministry of Health, Ministry of International Affairs
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Established in 1999
Website: http://portal.anvisa.gov.br 30
HOW TO START? 1 - Find a local registration holder
OPENING A SUBSIDIARY IN BRAZIL
FINDING A DULY LICENSED LOCAL DISTRIBUTOR
WORKING WITH THE HOSTING ALTERNATIVE
HOW TO START? Hosting Company Main responsabilities •
Maintenance of the sanitary permits
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Maintenance of qualified staff to meet the manufacturer needs
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Product liability towards consumer protection agencies, governmental and private entities, INMETRO
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Civil and criminal liability regarding the products
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Qualification of the distributors (documental inspection) and manufacturers
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Inform ANVISA about technical complaints and adverse events related to the product (Technovigilance or pharmacovigilance)
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Answering questions about technical surveillance issued by ANVISA
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Support and coordination of Recall processes
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Support distributors regarding the labeling of imported products
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Control of the import authorizations to ensure traceability
Medical Devices Registration All products are classified according to the level of risk and invasiveness they pose to human health, similar to MHRA, FDA etc: Class
Risk
CE Equivalence
Certificate
Renewal
I
low
I
notification (cadastro)
automatic
II
medium
IIa
III
high
IIb
every 10 years
IV
maximum
III
certification and GMP (issued by ANVISA or MDSAP)
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MAIN DIFFERENCES Comparison of risk classes: I and II
III and IV
Modality of process
Notification / Enrollment
Registration
Specific documents
Authorization Letter and technical dossier (RDC 40/2015)
CFG/CFS, authorization letter and documents proving safety and efficacy (RDC 185/2001)
GMP Certification (Good Manufacturing Practices certification issued by ANVISA for the manufacturer facility)
Not applicable
Mandatory
INMETRO Certification (Certificate of Conformity for the product, issued by the National Institute of Metrology, Standardization and Industrial Quality)
May be required
May be required
Undetermined
10 years
Validity
ANVISA – RECENT INITIATIVES ANVISA has been developing initiatives and measures to streamline the registration process of new medical products. Such initiatives include: - improved timeframe for responses to medical device submissions (around 90 days) - simple notification instead of full certification for products of classes I and II and automatic renewal - for classes III and IV renewal deadline was extended from 5 to 10 years - allows the transfer of registration of products among companies.
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Possible Required Certifications INMETRO Certification •National Institute of Metrology, Standardization and Industrial Quality •Goal: assure the safety and quality of the products through tests to evaluate the product and then issue a certificate of conformity by a Brazilian Certification Body. •Example of products: Equipment with battery or any type of power supply / Needles, syringes, gloves, breast implants, infusion sets, etc. •Electrical products: - 3rd edition of IEC 60601 is mandatory for most of the products - Portaria 54 approved in May, 2017 – new requirements - Tests reports = issuance date must be with less than 2 years and performed by ILAC laboratories - Valid for 5 years
Possible Required Certifications GMP Certification •Good Manufacturing Practices - risk classes III and IV •Inspection performed by ANVISA •Different approach when compared to FDA or other certifiers (ISO 13.485) •High ANVISA fee (around US$ 31,500.00*) •Valid for 2 years •GMP Certificate belongs to the Brazilian registration holder •Long waiting line – up to 2 years -possibility to speed up – Brazilian Associations members (7 months) or legal injunction (1,5 years) •MDSAP (45 days)
MDSAP PROGRAM ANVISA is implementing new procedures established by IMDRF (International Medical Device Regulation Forum) ANVISA is a member of MDSAP Program (http://portal.anvisa.gov.br/piloto-doprograma-de-auditoria-unica-mdsap) Participating authorities: Brazil, Australia, Canada, USA and Japan List of notified bodies approved for Brazil: https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/U CM429978.pdf
Advantages: ✓speed up the GMP audit (45 days)
✓avoid multiple audits ✓BSI is one of the notified bodies approved for Brazil
Pharmaceutical Registration ANVISA established eight categories for medicines registration: - new medicines;
- generic medicines; - biosimilar medicines; - botanic medicines; - biological & biotechnological medicines; - parenteral medicines in bulk; - homeopathic medicines and medicines that do not require registration
Foreign companies must establish a local office or assign a local partner to submit the petition for the registration of medicines
Pharmaceutical Registration Registration of a New Drug is similar to FDA`s NDA and IND process, and it is comprised of:
1 – Pre-registration measures: protocol for clinical study in compliance with Brazilian clinical trial legislation 2 – Registration: •Documents to be submitted – mandatory GMP certification emitted by ANVISA
•Protocol for the new drug – all clinical studies and proposed retail price •Protocol for import of a new drug – GMP required, labelling in Portuguese 3 – Post registration: alteration or renew of registration
ANVISA – RECENT INITIATIVES ANVISA has been developing initiatives and measures to streamline the registration process of pharmaceutical products. Such initiatives include: - ANVISA has applied to become a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – final evaluation in 2019 - ANVISA is part of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) - ANVISA is implementing CTD (late 2018) and forecasts implementation of eCTD by 2021 - Adoption of MedDRA terminology ongoing
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Import of Unlicensed Medicine Individuals can import unlicensed medicines in Brazil. The importation is possible through an exceptional solicitation for personal use. By submitting at ANVISA, the requests will be analysed by the Agency’s technicians that will verify their safety, efficiency and if they are registered on their country of origin or other countries. This measure also qualifies for the use of proscribed substances, which individuals can request the importation as described above. Other than that, interested companies can request the registration of the product in Brazil.
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DIT Brazil We offer
... and you get
Tailored market reports
Enhanced access to the key players drawing on our experience and contacts
Production of validated contact lists of agents, distributors, customers, key players Press and PR services Arrangements for special events such as product launches, seminar and receptions
Reduction in time spent searching for contacts Reduced risk of encountering the wrong contacts as we will vet them beforehand drawing on our local expertise
Support for participation in a trade fair/mission
Reduced overall risk through knowledge, advice and assistance
Development of a complete visiting programme when you come to the market
Faster identification of opportunities in the market Reasonable cost but high value Reduction in time spent with Logistics
our
local
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Support - UK Export Finance Support your client to acquire products and services with UKEF support! The UK Export Finance (UKEF) or Export Credits Guarantee Department, is the UK official export credit agency. UKEF is strategically and operationally aligned with the Department for International Trade (DIT) and it supports buyers in the financing of their business with British suppliers. Through competitive loans, UKEF allows your client to buy UK’s products and services paying in their local currency. Speak to our team to find out more about how we can help your buyer!
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Gareth Moore
Latin America Desk Director – Santander UK Gareth.moore@santander.co.uk +44 7925 642 899
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Q&A
Danilo Santos Business Development Manager - Brazil Danilo.santos@mobile.trade.gov.uk +55 11 3094-1866