Key Enabling Factors for Successful Local Production and ...

Training Workshop Report: Key Enabling Factors for Successful Local Production and Supply of Quality-Assured Medical Products, WHO South-East Asia Region

26 – 28 November 2019 Novotel Bangkok Sukhumvit 20 Hotel, Bangkok, Thailand

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This document, in part or in whole, may not be reviewed, abstracted, quoted,

transmitted, distributed, translated or adapted in any form or by any means without the

permission from the WHO Local Production Programme.

1. INTRODUCTION ............................................................... 1

2. WORKSHOP PROCEEDINGS ............................................ 2

3. TRAINING EVALUATION AND CONCLUSION ............... 11

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1. INTRODUCTION

Low- and middle-income countries (LMICs) still face challenges in access to quality-assured

essential medicines and health products. Local production of quality medical products is a key

pillar in strengthening access. Local production has been a subject of discussions in the World

Health Assembly (WHA) since the 1970s. The adoption of the Global Strategy and Plan of

Action on Public Health Innovation and Intellectual Property by the World Health Assembly in

2008 brought a new focus on local production as one action to contribute towards promoting

innovation, building capacity and improving access to essential medicines and health products.

There has been growing interest by LMICs to embark on local production. Member States

requested for support in promoting local production at the 71st WHA in the context of

discussions on the global shortage of, and access to, medicines and vaccines. Local production

has been cited in several high-level declarations and international fora as a potential strategy to

ensure health security through uninterrupted supply of medical products; attain universal health

coverage; and achieve cross-cutting health targets embedded in the Sustainable Development

Goals. At the 72nd WHA Technical Briefing on Local Production, the first interagency statement

on promoting local production was launched, signalling the aim of 6 international organizations

to work holistically, strategically and collaboratively with governments and other stakeholders in

promoting sustainable quality local production.

Strengthening local production is a cross-cutting endeavour. Sustainable local production requires

effective multisectoral collaboration to promote an enabling investment, legal and technical

environments. Lessons learned in providing technical assistance to manufacturers suggest that the

scope of assistance needs to be expanded beyond GMP and quality assurance standards into other

key areas such as business and policy considerations, which are necessary for local production to

be successful. Against this backdrop, WHO organized a training workshop to present and discuss

key enabling factors for the successful local production of quality-assured medical products in the

WHO South-East Asia Region in Bangkok, Thailand from 26 - 28 November 2019.

The goal of the training workshop was to strengthen the capacity of local manufacturers in the

WHO South-East Asia Region in the sustainable production of quality-assured medical products.

The specific objectives for the workshop were to:

i. Provide training and guidance to manufacturers and other participants on key business,

policy, regulatory and other factors critical to successful local production of medical

products.

ii. Share experiences and lessons learned in achieving quality local production of medical

products.

iii. Understand the gaps and needs in building the capacity of local manufacturers and

regulators to promote sustainable quality local production.

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The workshop had the following outcomes and outputs:

i. Capacity building for participants.

ii. Meeting report including any identified gaps in capacity building for manufacturers.

iii. Training package based on a compilation of the training materials presented during the

workshop.

iv. Principles and/or key concepts for consideration towards development of a ‘points to

consider’ for local pharmaceutical production.

The training workshop comprised four sessions namely Leveraging the business environment for

local production, Compliance with international GxP norms and other quality standards,

Regulatory Affairs, Opportunities and challenges for local production of vaccines, medical devices

and blood products. Presentations by experts was augmented with company experience sharing by

participants through presentations related to the topics covered during the training workshop.

In total, 95 participants attended the training workshop. These included pharmaceutical

manufacturers from Bangladesh, Malaysia, Myanmar, Sri Lanka, Thailand and Vietnam together

with manufacturers’ associations namely Bangladesh Association of Pharmaceutical Industries,

Myanmar Pharmaceutical & Medical Equipment Entrepreneurs' Association, Sri Lanka

Pharmaceutical Manufacturers’ Association, Thailand Pharmaceutical Manufacturers’

Association, The Directorate General of Drug Administration Bangladesh, Thailand Food and Drug

Administration, Thailand National Health Security Office, Bureau of Medicine and Medical Supply

and Vaccine Management. Other stakeholders who participated at the workshop included

international partners from The Global Fund, Medicines Patent Pool (MPP), UNCTAD, UNDP,

UNICEF and WHO. Two GMP experts from consulting firms also participated in the training

workshop.

2. WORKSHOP PROCEEDINGS

Dr Jicui Dong, Programme Manager for Local Production Programme, Regulation of Medicines

and Other Health Technologies (RHT), WHO HQ opened the workshop with an introduction of

Ms Emer Cooke, Director, RHT, WHO HQ and the invited officials from Thailand, Bangladesh

Sri Lanka, and Myanmar to deliver the welcoming remarks. Dr Dong stated there is the

continued dependency on imports of essential finished pharmaceutical products in the WHO

South-East Asia Region and the need to promote sustainable quality local production.

Ms Emer Cooke, Director, RHT, WHO HQ delivered welcome remarks remotely to participants.

Ms Cooke thanked the Food and Drug Administration (FDA) Thailand, the Directorate General

of Drug Administration (DGDA) of Bangladesh and the top leadership of the pharmaceutical

manufacturing associations of Thailand, Bangladesh, Sri Lanka and Myanmar for participating in

this workshop. She thanked the Thailand Government, the WHO Country Office Thailand and

WHO South-East Asia Regional Office for their support. Ms Cooke mentioned that effective

multisectoral collaboration and close partnerships are essential to promote an enabling legal,

investment and technical environment for sustainable quality local production and, with this

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spirit, the first interagency statement on local production signed by the top leadership of The

Global Fund, UNAIDS, UNCTAD, UNICEF, UNIDO and WHO was launched during the WHA

this May. Ms Cooke remarked this workshop is also a reflection of this spirit.

Dr Suchart Chongprasert, Director of Drug Control, on behalf of Dr. Paisarn Dunkum, Secretary

General of the FDA Thailand, delivered welcome remarks and mentioned the need for

collaboration and partnerships to develop the pharmaceutical industry. He mentioned that

Thailand had one of the most developed pharmaceutical industries in South-East Asia. Mr

Mozammel Hossain, Assistant Director from the DGDA spoke of the strengths of the Bangladesh

pharmaceutical industry especially in exports. Bangladesh has overseen an annual plan to

increase local production of pharmaceuticals over the years. Mr Rachod Thakolsri from the

Thailand Pharmaceutical Manufacturers’ Association, spoke of the need to build local industry

capacity and the importance of final cost of medical products to the patient. The Sri Lanka

Pharmaceutical Manufacturers’ Association’s Mr Sirimal Fernando mentioned that local

production in Sri Lanka was at the 20% level. Mr SM Shafiuzzaman from the Bangladesh

Association of Pharmaceutical Industries spoke of the success story of the pharmaceutical

industry in Bangladesh with 98% of total consumption coming from local production. Dr Zaw

Moe Khine representing the Myanmar Pharmaceutical & Medical Equipment Entrepreneurs’

Association highlighted the high dependence of Myanmar on imports of medical products and

sighting opportunities for growth for local industry.

Dr Dong also thanked the Thailand Government, speakers, participants, the WHO Country Office

Thailand and the WHO South-East Asia Regional Office for their support in making the training

workshop a reality. Dr Jicui Dong went through an overview of the agenda and highlighted the

objectives and outcomes of the training workshop.

2.1 Session One - Leveraging the business environment for

local production

Mr Sirimal Fernando Secretary General of the Sri Lanka Pharmaceutical Manufacturers’

Association moderated the first session of the training workshop. Speakers for this session were

as follows:

• Mr Leslie Ong - Program Analyst, UNDP Thailand

• Ms Jacqueline Enstone - Regional Supply Specialist, UNICEF East Asia and Pacific

Regional Office

• Mr Lin Li - Senior Manager, Strategic Sourcing, The Global Fund

• Ms Somruethai Supunkul - Project Manager, Thailand National Health Security Office,

Bureau of Medicine and Medical Supply and Vaccine Management

• Dr Jicui Dong - Programme Manager, Local Production Programme, WHO HQ

• Ms Erika Dueñas Loayza – Technical Officer, Intellectual Property Management, WHO

HQ

• Ms Sandra Nobre - Head of Business Development, Medicines Patent Pool (MPP)

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• Mr Chris Chitemerere - Consultant, Local Production Programme, WHO HQ

• Mr Christoph Spennemann (remotely) - Officer-in-Charge, Intellectual Property Unit,

UNCTAD

• Mrs Claudia Nannei – Technical Officer, Essential Medicines and Health Products, WHO

HQ

Mr Leslie Ong - Program Analyst, UNDP Thailand started the first session of the training

workshop with a presentation on Strengthening policy coherence to promote domestic

pharmaceutical production. Lessons learned from countries in starting stages of pharmaceutical

production show that these players typically have small market share and face strong competition

from imported finished pharmaceutical products. It was also pointed out that government

stewardship and intervention and a coordinated strategy are key for successful local production.

Three critical elements for local production namely access to markets, access to finance and

access to technology were pointed out as important in fostering local production of

pharmaceutical products. Key drivers for promoting domestic pharmaceutical production include

political leadership, overarching policies and government coordination platforms.

Ms Jacqueline Enstone - Regional Supply Specialist, UNICEF East Asia and Pacific Regional

Office, spelt out the mandate of the organization. UNICEF is mandated by the United Nations

General Assembly to advocate for the protection of children's rights, to help meet their basic

needs and to expand their opportunities to reach their full potential. The major commodity

groups procured through UNICEF include vaccines, pharmaceuticals, water and sanitation and

nutritionals. Major service areas procured include construction services, freight and local

technical workforce. Expression of Interest are published on the UNICEF website. The UN

Global Market Place is a source of information for procurement tenders, which suppliers should

subscribe to. Local manufacturers were urged to adhere to the UN Supplier Code of Conduct and

were advised to always respond to invited tenders making sure all required documentation is

complete. It was noted that supplying products and services through UNICEF is a long process

just like entering any new market and manufacturers were advised not to easily give up.

Founded in 2002, The Global Fund is the leading contributor of resources in the fight against the

three diseases namely HIV/AIDS, Malaria and Tuberculosis. Mr Lin Li - Senior Manager,

Strategic Sourcing, The Global Fund outlined the organization’s market shaping strategy which

aims to leverage the Global Fund’s position to facilitate healthier global markets for health

products – today and in the future. Procurement channels for the Global Fund include pooled

procurement mechanism (PPM), national procurement mechanisms and other procurements

agents/Global Drug Facility. 44% of the Global Fund’s Pooled Procurement Mechanism (PPM)

health product spend is for malaria-related products. The Global Fund has embarked on a

strategy to encourage local production through PPM and has a balanced supply system based on 5

elements namely cost-competitiveness, performance, sustainability, risk management and benefits

sharing. The Fund is moving away from spot tenders to long-term agreements and has embarked

on responsible procurement which considers environmental issues. Key considerations when

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bidding for tenders include bringing value to the market beyond price (e.g. being closer to the

customer/demand).

Ms Somruethai Supunkul - Project Manager, Thailand National Health Security Office (NHSO),

Bureau of Medicine and Medical Supply and Vaccine Management outlined the procurement

procedures of the organization. The NHSO considers a balanced perspective in its procurement

activities and is committed to the use of generic substitution. The Thailand National Medicines

List (NML) is used for procurement which is split into two categories namely general essential

medicines and special items. A Procurement Committee is in place to exercise the mandate of

NHSO. Demand forecasting is done using a population-based forecast and a utilization-based

forecast for each ensuing fiscal year. The quality of a medicine not price only is taken into

consideration during the procurement process.

Dr Jicui Dong - Programme Manager, Local Production Programme, WHO HQ made a

presentation on the first Interagency Statement on Promoting Local Production of Medicines and

Other Health Technologies. Dr Dong mentioned that the first interagency statement on

promoting local production was launched at the 72nd World Health Assembly Technical Briefing

on Local Production, signaling the aim of 6 international organizations to work holistically,

strategically and collaboratively with governments and other stakeholders in promoting

sustainable quality local production. The interagency statement highlighted the need for multi-

sectoral collaboration to promote an enabling environment for sustainable quality local

production. The statement also highlights the need to take a holistic approach in promoting local

production, which considers policy coherence, regulatory systems strengthening, skilled human

resource, and access to technology and needs-based innovation.

Ms Erika Dueñas Loayza – Technical Officer, Intellectual Property Management, WHO HQ

made a presentation on Understanding patents in the medical products industry. Local

pharmaceutical manufacturers should align business objectives to the industrial and health

policies of their countries. To further develop the pharmaceutical industry, it was mentioned that

there must be a coordinated strategy between government and the players in the industry and

needs should be the primary driver of the pharmaceutical industry. Working with health and

intellectual property authorities was given as a prerequisite for a successful local pharmaceutical

manufacturing sector. Intellectual property knowledge is important to build strategic alliances in

any country in which local pharmaceutical manufacturers operate in. Intellectual property and

trade were pointed out as important factors in improving access to health and increase

competition. The TRIPS Agreement and its associated flexibilities were given as essential pillars

in promoting local production. Countries were urged to domesticate the TRIPS Agreement and

its associated flexibilities.

The Medicines Patent Pool (MPP) was founded by UNITAID in the year 2010 as a mechanism to

promote sustainable access to medical products. Ms Sandra Nobre - Head of Business

Development, Medicines Patent Pool mentioned that through patent holders, the MPP gives

players in the pharmaceutical industry “Freedom to Operate” through provision of voluntary

licenses in specified geographical markets. This mechanism reduces launch times between Low-

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to Middle-Income Countries and High-Income Countries thus increasing access through price

reductions. To date, MPP has issued 109 sublicenses with 23 manufacturers covering 151 active

projects.

Mr Chris Chitemerere - Consultant, Local Production Programme, WHO HQ made a presentation

on Business Intelligence and Demand Forecasting. During the presentation, it was noted that the

business environment in which an organization operates presents opportunities and threats. The

information on opportunities and threats that exist in the business environment constitute business

intelligence. Pharmaceutical manufacturers need to continuously have access to business

intelligence which in turn forms the basis of market analysis and demand forecasting. Demand

forecasting in turn feeds into short and long-term planning activities such as new product

development and facility design.

Mr Christoph Spennemann - Officer-in-Charge, Intellectual Property Unit, UNCTAD made a

presentation on Requirements for technology transfer and joint venture opportunities. During this

presentation, it was emphasized that policy coherence was important for any technology transfer

project to succeed. It was pointed out that owners of technology call for a high level of cGMP

and quality from technology receivers to protect their interests. Local policies and laws play a

critical role in accessing technology. UNCTAD gave a practical example of Bangladesh through

the National Drug Policy of 1982 and the subsequent Policy Revision of 2005, the patent law

which does not provide for patents on pharmaceutical products, but processes only and thus

promote reverse engineering.

A presentation on Lessons learned from the GAP technology transfer initiative was given by Mrs

Claudia Nannei – Technical Officer, Essential Medicines and Health Products, WHO HQ. An

overview of the technology transfer initiative under the Global action plan for influenza vaccines

(2006-2016), a WHO programme aiming at increasing availability of influenza vaccines to

respond to pandemics was given. Two main areas of work were identified to achieve this aim, one

of which focused on the expansion of production capacity in low- and middle-income countries.

Sustainability of product, continued regulatory support and optimization of production capacity

were some of the key issues addressed during the project. After 12 years from the inception of

this programme, several issues were encountered, and corresponding lessons have been learnt.

Challenges faced during the implementation phase include lack of infrastructure and staffing,

sophisticated know how required and funding.

2.2 Session Two - Compliance with international GxP norms

and other quality standards

The second session of the training workshop was moderated by Dr Liviu Vedrasco Programme

Officer WHO Country Office Thailand. Topics in this session were presented by the following

speakers:

• Mr David Woo – Technical Officer, Local Production Programme, WHO HQ

• Mr Deryck Smith - Consulting Engineer, GMP Advisory Services

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• Mr Vimal Sachdeva – Technical Officer, Prequalification Team, WHO HQ

• Mr Alain Kupferman - Industry Pharmacist, Pharma Consulting & Engineering

A presentation on risk-based product selection was given by Mr David Woo – Technical Officer,

Local Production Programme WHO HQ. Mr Woo mentioned that product selection needs be

broad-based and should include factors such as availability and cost of quality input materials and

equipment, existing capabilities of the manufacturer, the level of technology need to develop and

manufacture the finished product, market demand and public health needs. It was mentioned that

one factor which needed to be assessed is whether the product candidate could be manufactured

with assured quality, safety and efficacy. The WHO Local Production Programme has developed

a risk-based assessment tool to assist manufacturers in selecting a product candidate that is

commensurate with existing capabilities and to ensure quality of the finished product. Participants

were shown some aspects of manufacturing a product which could impact on the quality of the

finished product and are included in the WHO risk-based assessment tool.

Mr Deryck Smith - Consulting Engineer, GMP Advisory Services gave a presentation on the

design of a cGMP compliant facility. The presentation touched on the inter-relationships and

influence on each other between facility architectural layouts and HVAC or Environmental

Control Systems. It was mentioned that the basic functions of HVAC systems are protection of

product, operators and the environment. The presenter emphasized the importance of temperature

and relative humidity in product protection. Mr Smith mentioned that the quality and location of

HVAC components affect product quality and cleanrooms (controlled environment) are an

important aspect of facility design. He further mentioned that self-inspection is a legal or

regulatory requirement, enables better understanding of the facility and promote continual

improvements to ensure quality.

After the presentation on facility design, Mr Vimal Sachdeva – Technical Officer,

Prequalification Team, WHO HQ gave a presentation on Achieving facility compliance with

WHO/International GxP standards. It was mentioned that as a fundamental rule, it is important

for pharmaceutical manufacturers to follow cGMPs. The focus of his presentation was on the 5

P’s of GMP namely People, Premises, Procedures, Processes and Products. He mentioned that the

5 components of GMP help to improve the product quality, ensure the consistent quality and

safety of products and minimize the risk of product recall. An important aspect of compliance is

design of facilities as it sets the pace for compliance. Mr Sachdeva pointed out that WHO

Prequalification follows a process which requires dossier submission, and that without a dossier

no inspection would be undertaken. It was noted that WHO has moved away from Stringent

Regulatory Authority terminology to WHO Listed Authority. Types of inspections carried out by

the Prequalification team include routine, concise and non-concise inspections with data integrity

playing a crucial role in the process.

Mr Alain Kupferman - Industry Pharmacist, Pharma Consulting & Engineering made a

presentation on Introduction to Quality Risk Management. Mr Kupferman noted that risks arise

at any stage throughout the pharmaceutical supply chain. There are many types of risk in the

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pharmaceutical industry which include operational, product, finance, supply chain,

pharmaceutical and many more. It was mentioned that participants should acquaint themselves

with these various risks, and especially quality risks. The presenter stated that validation should

be informed based on critical quality attributes and critical process parameters and ICH Q9 forms

the basis of implementing Quality Risk Management. Quality Risk Management implementation

follows the steps of assessment, control, reviewing and is done systematically, both proactively

and retrospectively.

Mr Vimal Sachdeva made another presentation on selection, contracting and audit of quality

service providers including API suppliers and CRO service providers. The presenter the

emphasized the role played by risk assessment in selecting services providers. It was mentioned

during the presentation that there must be a Standard Operating Procedure in place for

outsourcing service providers. Inclusion/exclusion of suppliers from an assessment requires that

this be well documented providing the rationale for doing so. Assessment or qualification criteria

for suppliers should be based on cGMP, ISO 9001 and ISO 17025 standards, whichever is

applicable depending on the type of the products . Mr Sachdeva pointed out that confidentiality

agreements are important and should be in place for all suppliers of services.

Mr Deryck Smith gave a detailed presentation on HVAC Control Systems and Validation. The

presentation pointed out that BMS validation depends on sensor output with sensors handling

regulatory data requiring validation and only verification in the absence of regulatory data. The

presenter also touched on calibrations of sensors, the need for data audit trail and the importance

of a fan failure matrix during the validation process. Typical functions of a BMS include control

and display functions. User Requirement Specifications (URS) were noted as a very important

document during the qualification process. Validation is a process which never ends and any

significant change in plant or layout requires re-validation. Risk assessment determines what

needs to be qualified and it was mentioned that there should be a limit on what to qualify.

2.3 Session Three - Regulatory affairs

The Secretary General of the Bangladesh Association of Pharmaceutical Industries Mr SM

Shafiuzzaman was the moderator for session three. Presenters for this session were:

• Mr David Woo – Technical Officer, Local Production Programme, WHO HQ

• Dr Suchart Chongprasert – Director of Division of Drug Control, FDA Thailand

• Mr Mozammel Hossain – Assistant Director, Bangladesh Directorate General of Drug

Administration

Mr David Woo – Technical Officer, Local Production Programme WHO HQ gave another

presentation on Good submission practices. He mentioned that the quality of the dossier

submitted to the national regulatory authority could impact on the efficiency of the NRA.

Implementing good submission practices enables submitted dossiers to be complete and

consistent, which enables the NRA to be efficient in reviewing dossiers and reaching regulatory

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decisions. He further mentioned that Good submission practices can be applied in any situation

that requires documents to be submitted to the NRA for review, e.g. marketing authorization,

GMP audit, post-market surveillance.

Dr Suchart Chongprasert – Director of Division of Drug Control, FDA Thailand made a

presentation on Dossier review, NRAs’ experiences with local manufacturers. His presentation

touched on the approach FDA Thailand follows, mentioning that the organization follows Good

Review Practices. The process involves validation and scientific review components.

Documentation of the review process is considered best practice. Dr Chongprasert pointed out

that poor communication is a cause of failure in many reviews. He concluded his presentation by

mentioned that the overall quality of dossiers submitted by local manufacturers in Thailand is

relatively acceptable but can be improved.

Mr Mozammel Hossain – Assistant Director, Bangladesh Directorate General of Drug

Administration closed off session three of the training workshop with a presentation entitled

DGDA Achievements and Challenges for WHO Pre-Qualification. The presenter mentioned that

regulators are an essential part of the health workforce and effective regulatory systems are an

essential component of health systems and contribute to better public health outcomes. The

Directorate General of Drug Administration (DGDA) is the only responsible regulatory authority

to control quality, safety and efficacy of medicines in Bangladesh. The DGDA, with technical

support from WHO and other development partners has established a coalition of interested

partners (CIP), and task force which aims to coordinate activities with partners supporting

regulatory strengthening efforts for medical products in Bangladesh. The DGDA prepared a road

map in March 2016 which was followed by an institutional development plan as an instrument for

self-assessment. These documents are continuously updated according to emerging needs and

follow the WHO global benchmarking tool (GBT).

2.4 Session Four - Opportunities and Challenges for local

production of vaccines, medical devices and blood products

Session four was moderated by Ms Puttimon Sribonfha from the Thailand Pharmaceutical

Manufacturers’ Association. The following speakers made presentations for this session:

• Dr Jicui Dong - Programme Manager, Local Production Programme, WHO HQ

• Dr Yuyun Maryuningsih – Scientist, Technologies Standards and Norms, WHO HQ

A presentation of Local production of vaccines in the WHO South-East Asia Region was given

by Dr Jicui Dong, Programme Manager – Local Production Programme WHO HQ. During the

presentation, Dr Dong mentioned that there is overwhelming evidence that shows the public

health benefit of vaccines. It was revealed that in the last decade, great advances have been

made in developing and introducing new vaccines, and vaccine producers in developing countries

contribute to the global procurement of vaccines. Despite challenges with technology transfer in

vaccine manufacturing, technology transfer has proved to be effective in building local

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production capacity. The prequalification of vaccines has been found to be effective in the

procurement of quality-assured vaccines.

Dr Yuyun Maryuningsih – Scientist, Technologies Standards and Norms WHO HQ gave a

presentation on Local Production of Blood Products – Quality Assurance and Safety. During the

presentation Dr Maryuningsih mentioned that insufficient or unsafe blood products supply have a

negative impact on the effectiveness of health care and the WHA 63.12 (2010) resolution urges

Member States to achieve self-sufficiency in safety and quality of blood products. It was pointed

out that access to safety and quality of blood products is an ongoing challenge in low- and

middle-income countries (LIMCs) and local production is one potential way to increase access to

blood products. Dr Maryuningsih revealed that The WHO Achilles Project in Indonesia (2012-

2014) could become a lesson learnt on how the LMIC country dealt with this challenge through

strengthening their blood regulatory system, technology, quality management and quality

measures systems in local production of blood products.

2.5 Company Presentations

Company presentations were used to share experiences of manufacturers in applying the topics

covered throughout the training workshop. The key messages from these company presentations

are presented below with key messages from the training workshop presentations.

2.6 Key Messages

Dr Jicui Dong presented the key messages to manufacturers emanating from the training

workshop and the company presentations.

Key messages from the workshop presentations are listed below:

• A holistic and coordinated strategy is needed to promote local production.

• An enabling policy, business and regulatory environment is critical to the sustainability

of local production.

• Government involvement is essential to address the challenges faced by industry.

• International procurement tenders are evaluated based on value for money rather than

price alone, e.g. quality assurance, proximity to the need, supplier performance.

• Ensuring the quality of medical products will help to build public trust and confidence.

• To succeed in the pharmaceutical marketplace, it is vital to stay up to date with business

developments in the dynamic business environment.

• Promoting innovation and access needs to consider the interactions between public

health, trade and intellectual property

• R&D linkages between industry and research institutions are important to support

innovation in local production

• Licensing agreements should be reviewed to mitigate any impact on the access to

medical products and ensure both parties will benefit

• The TRIPS Agreement includes flexibilities that can be adapted at the national level to

meet development and social goals and safeguard public health

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• The expansion of MPP’s scope to other patented essential medicines (in areas such as

cancer, type 2 diabetes, reproductive health) could be opportunities for local production

of much-needed medicines

• Product selection should be risk-based and holistic and include a risk assessment of

whether the candidate can be produced with assured quality, safety and efficacy.

• The HVAC system design influences the architectural design and layout of a facility.

• HVAC control and monitoring systems and its qualification and validation have a major

impact on product quality.

• Self-inspections enable a better understanding of the facility and promote continual

improvements to ensure quality.

• Achieving facility compliance with WHO GxP standards are key to production of high

quality medical products.

• Quality risk management is a systematic process to assess and control risk that can be

applied proactively and retrospectively.

• Selecting, contracting and auditing suppliers and service providers is a key component to

ensure product quality.

• Implementing good submission practices could improve the efficiency of the NRA to

reach regulatory decisions.

• Lack of communication between manufacturer and the NRA is a key factor for

unsuccessful dossier submissions/reviews.

• strengthening the NRA is a key factor to expand the global pharma market.

• Product Development Partnerships could be one strategy to facilitate technology transfer

and local production for the development and local production of vaccines in developing

countries.

• Good Manufacturing Practice should be strictly implemented at Blood Establishments

and within the Plasma Industry to ensure safety and quality assurance of blood products.

Key messages from company presentations are summarized below:

• Leadership must have a vision for successful local production.

• There are opportunities for vaccines and biosimilar products in Bangladesh because of

the exit by large multinationals.

• Product quality must be achieved at an affordable price.

• Lack of qualified local personnel is a huge challenge to local production.

• The Bangladesh pharmaceutical industry is being pushed forward by exports, which in

turn lead into high quality medical products.

• Myanmar lacks policies that support local production with importation of finished

pharmaceutical products being cheaper than importation of raw materials.

3. TRAINING EVALUATION AND CONCLUSION

Feedback from the participants were provided through evaluation forms as well as participatory

discussions. The participants appreciated the workshop and thanked WHO for organizing such an

important workshop. Breaks during long sessions of presentations (e.g. a short dance break) were

taken positively. Participants also provided suggestions for future workshops, such as the use of

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QR codes and carrying out the workshop at the national level as countries differed in their

strengths in terms of local production.

Dr Dong proceeded to close the workshop.

Key Enabling Factors for Successful Local Production and ...

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