Opportunities and Chalengges in Pharma Industry Development to Improve Indonesia Pharma Industry Competitiveness-GP Farmasi

Opportunities and Challenges in Pharma Industry Development

to Improve Indonesia Pharma Industry Competitiveness

“It is

Health

that is Real

Wealth

and not pieces of Gold

and Silver”

-

Why Developing Indonesia Pharma Industry?

Availability, Independency, and Sustainability of Supply

Medication Cost Optimalization

Pharma Technology Acquisition Indonesia Herbal & Marine

Potency

Devisa Saving

Contribution to GDP and Job Opportunity

Social Aspect

Technology Aspect

Current Status Indonesian Pharma Industry

No. of Manufacturers

Value (IDR bio)

Share (%)

Growth vs. LY (%)

Source : Kemenkes 2014, IMS Report Q2 2015

State Owned Local MNC

4 178 24

45,699 16,388

74.6% 25.4%

6.72% 15.3%

Indonesia Pharma Market has hit >60 trillion

MAT Q2 2015: Growth 8.9% (value) or 9.7% (volume)

JKN Implementation (Unbranded Generics

VOLUME )

Branded Generics &

OTC _Price Hospital Demand 

JKN Implementation (Unbranded Generics

PRICE )

Rp-USD

Exchange Rate  New Product Launched 

Indonesia Expectation Heading 2025

Source: http://www.ieconomics.com

64

Productivity Rate per Labor GDP per Capita Life Expectancy

Indonesia Health Care Expenditure as % of GDP

Source : Pharmaceutical & Healthcare Countries Report Q2 2014, Business Monitor International; Economic 360 for Indonesia Healthcare Industry, 2011, Frost & Sullivan

Government shall increase Health Care Expenditure to

5%

of APBN

(Ref. UU Kesehatan No. 36/2009 pasal 171.1)

Indonesia Health Care Expenditure per Capita

Strong Industry Growth & Future Objective

Source: http://www.kemendag.go.id/id/economic-profile/indonesia-export-import/growth-of-non-oil-and-gas-export-sectoral

-2015 2020 2025

Indonesia Pharmaceutical National Market Value

147 T

450 T

Optimistic Annual Growth: 20%

GDP Contribution : 1.3-1.5% (2025)

100 200 300

2015 2020 2025

Indonesia Pharmaceutical Export Value

100 T

250 T

Import Value : +/- IDR 21 T (2013),

dominated by raw material import

V

Commitment from

ABCG

Job Opportunity

2 million jobs

Investment

needed

Rencana Induk Pengembangan Industri Nasional

Peraturan Pemerintah nomor 14 tahun 2015

Indonesia Pharma Industry Roadmap Journey

Kick Off Meeting (16 Apr 14)

Presentation to Dirjen Binfar (05 Sep 14)

Presentation to Kepala BPOM (16 Sep 14)

Presentation to Menteri Kesehatan I (10 Oct 14)

Presentation to Menteri Kesehatan II (12 Dec 14)

Indonesian Pharmace_{utical Industry Road Map} 2015 - 2025

December 2014

Final version (17 Dec 14) Presentation in Rakor

Kemenko Perekonomian (05 Aug 15)

PP 14/2015: Pharma Industry as National Industry Priority

Rakor Kemenko Perekonomian

–

05 August 2015

Participants: Menko Perekonomian, Menteri Kesehatan, Menteri

Ristek-Dikti; Dirjen Kemenkes, Kemenperin, Kementan, Kemenkeu, BKPM, etc

Conclusion:

1. Deputy V Kemenko Perekonomian will develop Peraturan Presiden draft to support Pharma Industry Roadmap implementation. The draft then will be distributed to relevant stake-holders for feedback. 2. Deputy V Kemenko Perekonomian will coordinate with Kementerian

National Pharma Pillars to realize the Transformation 2025

15

INDONESIA PHARMA INDUSTRY AS NATIONAL STRATEGIC INDUSTRY

Collaborative R&D Mission

1. To satisfy domestic drugs and medication market, including JKN & KIS

2. To contribute foreign exchange, export & import substitution

3. To master pharmaceutical technology, including R&D and talent pool Vision 1. To become Top 15 World Pharma in 2025 with IDR 700 T market value

Quality and efficient Manufacturing Regulation to support industry

ABGC forum Alignment

Infrastructure to support industry growth Competent Human Resource

Bio-Pharma _{Vaccine Chem-API}

JKN & KIS:

Availability, Affordability, Accessibility

Export Program & Import Substitution: Foreign Exchange Contribution

Formulation Manuf. Dist. & Export

Transformation of Indonesian Pharma Industry

From Formulation to Integrated Pharma Industry

16

Import (API & Excipient) Formulation Manuf. Dist.

Current

R&D Clinical Trial

Inter-mediate API

API PERIOD

2015-2018 2019-2022 2023-2025

BIOPHARMA-CEUTICALS

• EPO (Erythropoetin)

• GCSF (Granulocyte Colony Stimulating Factor)

• Probiotic

• Insulin (utk diabetes)

• Stem cell protein (Wound care and cosmetics)

• Somatropin

• EGF (Epidermal Growth Factor)

• Enoxaparin (pengencer darah)

• Blood Fractionation (Albumin,

Immunoglobulin, Factor VIII, Factor IX)

• Growth Hormone (hormon pertumbuhan)

• Interferon (pelindung tubuh dari berbagai virus)

• Trastuzumab (antibodi monoklonal yang dirancang untuk bekerja pada target

HER2 positive breast cancer)

• Insulin

• MAB (oncology)

• MAB (Monoclonal Anti Body)

• Insulin analogue

VACCINE

• Dengue (Demam Berdarah) • MR (Measles Rubella)

• HB (Hepatitis-B)

• Hexavalent (dimulai)

• Sabin IPV (Inactivated Polio Vaccine)

• Rotavirus (dimulai)

• Typhoid Vi-Conj

• Rabies (dimulai)

• DTaP (Diphteri, Tetanus, acellular Pertussis)

• Hexavalent

• MenACWY

• New OPV type 2 (for stockpile)

• Pneumococcal (vaksin pneumoni)

• Rotavirus

• Rabies

• HPV (Human Papiloma Virus)

• New TB Recombinant

NATURAL

• Dehidro-di-Isoeugenol (Ekstrak Biji Pala)

• Curcumin (terkadung dlm temulawak utk liver)

• Gingerol (komponen kimia dalam jahe)

• Phylantin (ekstrak daun meniran)

• Piperin (ekstraksi lada hitam)

• Steviosid (pemanis non kalori)

• Xanthorhizol (komponen minyak atsiri khas temulawak)

• Zederone

• Glucosamin (utk persendian dproduksi dlm tubuh atau diekstrak melalui kulit kepiting atau udang)

• Omega-3

• Resveratrol (anti oksidan alami)

• Vinca alkaloid derivates

• Isolat gandarusa (kontrasepsi pria dan wanita)

• Isolat alga coklat (wound care)

• Isolat mikroba simbion karang laut (antibiotik)

• Isolat Guazuma longifolia

• Andrographolide (anti malaria)

• Etil-p-metoksi Sinamat (hasil isolasi rimpang kencur utk pelindung kulit)

API PERIOD

2015-2018 2019-2022 2023-2025

NATURAL

• Ekstrak sambung nyawa (antihiperkolesterolemia)

• Ekstrak temulawak (antihiperkolesterolemia)

• Ekstrak seledri (antihipertensi)

• Ekstrak kumis kucing (antihipertensi)

• Palm sugar

• Ekstrak Cinnamomum burmanii

• Fitoestrogen (Trigonella foenum-graceum)

• Dermifix Wound Healing (Centella asiatica)

CHEMICALS

• Statin derivates (menurunkan kadar kolesterol: Simvastatin, Atorvastatin, Rosuvastatin)

• Pantoprazole

• Clopidogrel

• ARV (Entecavir, Tenofovir)

• Beta-Lactam (Amoxicillin)

• Pharma Salt (garam farmasi) (NaCl pharma-grade)

• Dextrose pharma-grade

• Lyophilisation substances

• Pen-V

• Pen-G

• Magnesium stearate

• Paracetamol

• ARV (Entecavir, Tenofovir)

Healthcare Sector Transform to Become Personalized, Predictive,

and Preventive

Genetic Mapping

Patient segmentation tailored treatment

regimens

Advancements in predictive and

preventive medicine

Personalized Medicine

Source: Frost & Sullivan Analysis

Transformation in Health Sector

FROM TO

One size fits all APPROACH Personalized Medicine

Fragmented, One way INFORMATION FLOW Integrated, Two Way

Provider centric FOCUS Patient Centric

Procedure – based REIMBURSEMENT Bundled, Capitated

Centralized, Hospital-based LOCATION Decentralized, Community-based

Fragmented, Specialized TREATMENT Collaborative, Shared Information

Based on Individual Expert DECISION MAKING Based on Protocols and Analytics

Treating Sickness OBJECTIVE Preventing Sickness (Wellness)

Transformation in Health Sector

Source: Frost & Sullivan Analysis

Global Healthcare

Spend

Better health through earlier diagnosis

The most advantageous way to combat many diseases, such as diabetes or cancer is to predict susceptibility, characterize and begin preventive treatment before the onset of the disease

Screening and Localizing diseases is the most efficacious and cost effective approach to improving quality of life

Predict, 5% Predict, 9%

Predict, 22% Diagnose, 15%

Diagnose, 19%

Diagnose, 27% Treat, 70% Treat, 60%

Treat, 35%

Monitor, 10% _{Monitor, 12%}

Monitor, 16%

2007 2012 2025

Global Healthcare Spend

The Five Selected Future Technologies

Bio-Tech

Natural

Diagnostic

DDS

Main Opportunity for Indonesia Pharma Industry

1. Future Economy Growth will Enlarge Pharma Market Significantly

• High growth in GDP per Capita will enhance people awareness to their health. This may lead health expenditure to 4-5% of GDP

• Government commitment to support Pharma Industry as one of their priority in next 20 years, will boost pharma investment

• Opportunity in export market, including to advanced countries, is not yet explored optimally today

2. High Volume Growth for Generics

• JKN will endorse high volume growth for generic drugs demand, and may slow-down branded-generic drugs growth

• The most efficient industry, both in raw material purchase price and operational cost, will win JKN generic drugs market

3. “Out of Pocket” Market will be still Exist and Growing

Niece-market that not covered by JKN (e.g. for aesthetic purpose) and for some treatment which ceiling compensation is relatively small

(e.g. for cataract-medication, etc); advanced medication, premium treatment / service, and private insurance will be the main drivers for

Main Challenges for Indonesia Pharma Industry

1. Dependency on Raw Material Importation

• More than 95% raw materials (pharma-grade) are still imported, mostly from China, India, and western Europe.

• Pharma product cost structure is vulnerable to Rp-USD exchange rate fluctuation

• Generic product price, which regulated by government, become non-feasible due to weakening Rp-USD exchange

2. Strangling Regulation

• As Indonesia joining PIC/s, industry must adopt PIC/s regulation to comply cGMP. At the moment, most industries (and other supporting industries) are not yet ready to fully adopt it, e.g. requirement to use GMP-approved raw materials starting 2016.

• Government too focus on role to “supervise” industry, while their role

1. PATHOLOGICAL

We haven’t ever been caught, so we

must be doing pretty good (No CAPA,

NO QMS and No QRM)

2. REACTIVE

Compliance is important, so we do a lot

every time we have a problem (CA and PA??,

QMS?? No QRM)

3. CALCULATIVE

We have systems in place to manage

most compliance risks (CAPA, QMS and QRM??)

4. PROACTIVE

We work sensibly on the problems that

we still find (CAPA, QMS, QRM, MAI?? and

CI?? )

5. GENERATIVE

Compliance is just part of how we do business

here (CAPA, QMS, QRM, MAI and CI)

Monitoring, Assessment and Improvement (MAI)

Continuous Improvement (CI)



Maturity of GMP Attitude and Compliance

Main Challenges for Indonesia Pharma Industry

3. “Jaminan Produk Halal” (JPH) Law Implementation

• UU no. 33 / 2014 requires all drugs should follow halal-certification

• UU JPH may potentially disturb products availability to support JKN

• Future pharma product will be dominated by biologic-products, will be challenge to adopt halal-certification

• International Halal Pharma Summit (in CPhI Conference) stated that NO international standard for halal pharma products.

4. Fast Demand Growth vs. Capacity Building

• High investment for new plant with relative low ROE, especially for generics product

• Long lead-time to setup new production facility, dominated by permit issuance (CPOB certification and product registration)

• Limited human-resources (Apoteker, Assisten Apoteker, Lab-Analyst) to support Pharma industry growth, both in quantity and quality / competency

THANK YOU !

Rekomendasi Roadmap Industri Farmasi (1)

Memperkuat Struktur Industri Farmasi

• Kolaborasi industri farmasi (untuk R&D) • Kolaborasi

industri-akademisi-pemerintah-komunitas (Forum ABGC)

• Ketersediaan & kontinyuitas bahan awal dan bahan penunjang lainnya

• Penyiapan kluster industri dan infrastruktur

• Peran Kemenkes, Kemenperin, Kemendag untuk membina-mendukung industri farmasi

PIC: Kemenkes, Kemenperin, Kemendag, Kementan

Pengembangan Investasi

• Promosi investasi untuk industri farmasi

• Penyiapan infrastruktur dan peraturan untuk menarik dan mempermudah investasi

• Evaluasi peraturan yang berpotensi menghambat investasi (misalnya terkait fraksinasi darah, JPH)

• Penyediaan lahan/kluster industri dan infrastuktur

• Pengembangan industri penunjang (bahan kimia dasar, budi daya tanaman / plant-tissue culture, dll)

Insentif Fiskal, Pembiayaan

• Harmonisasi tarif impor • Pembatasan kuota impor • Insentif pajak dan bea-masuk

• Kemudahan akses pembiayaan, baik dalam & luar negeri) PIC: Kemenperin, Kemenkeu, OJK

Teknologi dan Sumber Daya Manusia

• Pendanaan untuk penelitian dan start-up industry bahan baku obat

• Mendorong transfer teknologi kefarmasian

• Memperkuat joint-research, baik dengan universitas ataupun lembaga riset lainnya

• Memperjelas proses, timeline, dan screening paten

• Dukungan pengembangan SDM sesuai kebutuhan industri farmasi

• Program pemanggilan kembali ilmuwan asal Indonesia • Pembangunan pusat uji klinik dan CRO

PIC: Kemenkes, Kemenperin, Kemenristek-dikti, Kemenkumham, Kementan, Kemenkeu, BPOM, BPPT, LIPI,

Pengawasan

• Peredaran bahan baku obat (API), bahan penunjang, dan obat illegal • Pengendalian impor obat, khususnya suplemen dan produk herbal • HAKI

• Peredaran obat melalui jalur non-konvensional, misalnya MLM dan on-line shopping

• Implementasi peraturan yang mewajibkan industri farmasi asing mendirikan industri berbasis riset di Indonesia

PIC: Kemenkes, Kemenperin, Kemendag, Kemenkumham, Kemenkeu, BPOM

Jaminan Penggunaan Hasil Produksi Industri

• Penggunaan untuk JKN melalui skema long-purchase agreement

• Persyaratan bahan baku lokal untuk program pengadaan obat pemerintah

• Pengendalian (buka-tutup) impor bahan baku obat • Promosi ekspor dan menghilangkan hambatan ekspor • Edukasi, pendampingan, prioritisasi oleh regulator untuk

perijinan dan registrasi produk

PIC: Kemenkes, Kemenperin, Kemendag, BPOM

Penunjang Lainnya

• Pendirian Biofarma Life Science Industry (BLSI) :

• Animal Laboratory Center (BSL 3)

• Research Center

• Manufacturing

• Bio-conservation

• Penyertaan Modal Negara (PMN) untuk lahan Jasinga merupakan prerequisite pendirian BLSI

• Menyiapkan industri ADS (Auto Distract Syringe), cartridge, prefilled syringe

• Menyiapkan infrastruktur cold chain

PIC: Kemenkes, Kemenperin, KBUMN, Kemenkeu