[01.24] Philippine Drug Industry, Drug Distribution, and Regulation V2.pdf

Commodity, right, wealth

What are the three different perspectives on health mentioned in the source?

Useful as a tool or means to mobilize communities, to enforce a form of social engineering

From which perspective is health considered a commodity?

Innate to every individual, everyone has access and is able to receive health goods and services, everyone has to be covered by health financing

From which perspective is health considered a right?

Discrete and measurable, a form of power that can assess progress and relative strength

From which perspective is health considered a form of wealth?

Health is useful

What is the health perspective taken by the public sector/government?

Consistency, coherence, and involvement of all its parts

What is expected of the Philippine government in its policies and standards?

Rational, consistent, clear, global yet flexible

According to the source, what characteristics must the Philippine government exhibit to work well with other actors globally?

Republic Act no. 9711, The Food and Drug Administration Act of 2009

What is the legislative basis for the adopted definitions of health products, drugs, and medical devices?

Food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances

What does the term "health products" encompass according to RA 9711?

Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals

What is one clause in the definition of a "drug" according to RA 9711?

Articles (other than food) intended to affect the structure of any function of the body of human beings or animals

What is another clause in the definition of a "drug" according to RA 9711?

Derived from cells, tissues, or microorganisms

What are "biological products" characterized by?

Diagnosis, prevention, monitoring, treatment, or alleviation of disease

What is one specific purpose of a "medical device" as defined by RA 9711?

Does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means

What is a key characteristic of a medical device regarding its primary intended action?

Minimal

What is the current state of health product trade in the Philippines?

No active manufacturers producing Active Pharmaceutical Ingredients (API)

What is a key reason for the minimal health product trade in the Philippines?

Imported

Where are active ingredients like paracetamol, co-amoxiclav, azithromycin, and bromhexine sourced from for local tablet/capsule/syrup production?

Technologically complex and a bit distant capability-wise

Based on the Atlas of Economic Complexity by Harvard University, what are biopharmaceutical products characterized as for the Philippines?

National pride

Beyond economic stability, what else does the establishment of a biopharmaceutical industry represent for countries like France, the UK, and the US?

Extent of resources, complexity of technology and science, and the regulatory gauntlet

What factors make it discouraging for companies to start innovating and manufacturing drugs in the Philippines?

Vaccines, monoclonal antibodies, serums

What specialized aspects of the pharmaceutical industry have more progressive countries focused on in the last 20 years?

Philippines in the Health Product Supply Chain Drug discovery, raw materials (active pharmaceutical ingredients), suppliers for raw materials

What are the key aspects the Philippines currently lacks in the health product supply chain?

Lagundi

What is the only notable raw material of pharmaceutical importance produced domestically in the Philippines?

Nucleic acids, primers, antibiotic raw materials

What specific materials need to be imported for pharmaceutical production in the Philippines?

Clinical trial facilities, contract research organizations, manufacturing capabilities, ability to produce fluids (IV fluids/swero), laboratories, good intellectual property regime, very good packaging and logistics

What aspects does the Philippines possess in the health product supply chain?

Strong demand

Why is the consumption side of health products not problematic in the Philippines?

Counterfeits, product diversion, grey market

What illegal or non-compliant means of distribution exist due to strong demand for health products in the Philippines?

Stable water supply, power supply, modernization of agriculture, transport, logistics, Intensified Cleanliness Policy (ICP)

What elements are needed to strengthen the Philippines' supply for upstream biopharmaceutical industrial activities?

Not one person can do it (it takes a village)

What collective effort is required to put together the necessary elements for a biopharmaceutical industry?

Active pharmaceutical ingredient source, contract-manufacturing organization, receiving a warning letter from the FDA regarding intellectual property rights

What are potential issues or risks drug manufacturers face in the supply chain?

Partnerships & Regulation Trust

What is the fundamental basis for partnerships in establishing a biopharmaceutical industry?

Complete, timely, consistent, coherent

What characteristics should communication have in partnerships?

World Health Organization (WHO), United Nations (UN), Food and Agriculture Organization (FAO), US Government, The Gates Foundation, European Union, World Bank, Asian Infrastructure Investment Bank (AIID), Asian Development Bank (ADB)

Name at least three multilateral organizations or partners the Philippines may tap for help in establishing a biopharmaceutical industry?

USAID (United States Agency for International Development)

Which US agency has provided significant funds for the development and execution of health projects in the Philippines?

China

Which country primarily bank-rolls the Asian Infrastructure Investment Bank (AIID)?

Japan

Which country primarily bank-rolls the Asian Development Bank (ADB)?

China, Japan, South Korea, Taiwan, USA

Name at least three leading trade partners of the Philippines based on import data in 2017.

China, USA, Hong Kong, Japan, Thailand

Name at least three leading trade partners of the Philippines based on export data in 2017.

Technology transfer

What important part of initiating a biopharmaceutical industry can these leading trade partners be sources of?

The relationship between the public and the private sector

What does partnership entail beyond other countries and the Philippines?

Regulatory pyramid

What framework illustrates the 6 layers of instruments the government can use to assert its influence?

Volunteerism, Peer Review, Clinical Guidelines

What instruments are at Level 6 (bottom/frontline) of the regulatory pyramid, used most frequently?

Professional organizations

Who typically makes clinical guidelines?

Self-regulation, Accreditation, Disclosure

What instruments are at Level 5 of the regulatory pyramid?

Intellectual Property Office of the Philippines

Which organization exerts a largely self-driven form of regulation for intellectual property?

Financial Instruments, Extra pay for Accredited Facilities, Case Mix Group Payment

What instruments are at Level 4 of the regulatory pyramid?

Philhealth

Which agency can incentivize good or compliant behavior among those receiving its benefits via financial instruments?

Co-regulation, Medical Boards, External Audits

What instruments are at Level 3 of the regulatory pyramid?

Physician licensure exam (PLE) administered by the Philippine Regulatory Commission (PRC)

What is an example of a Level 3 co-regulation instrument?

Meta-regulations, Mandatory Standards, Mandatory Accreditation

What instruments are at Level 2 of the regulatory pyramid?

Food and Drug Administration (FDA) and Health Facilities and Service Regulatory Bureau (HFSRB)

Which Department of Health agents enforce mandatory standards and meta-regulations?

Regulations that can require those subject to it to issue regulations themselves

What are meta-regulations?

Command & Control, License Suspension

What instruments are at Level 1 (top) of the regulatory pyramid, used sparingly?

Department of Health (DOH) and Supreme Court

What are the primary agencies that exercise command and control and license suspension?

Trends in Regulation Improvement of the public-private partnership

What is one observed trend in regulation?

The government has to negotiate with other governments (government-to-government)

How does the government facilitate technology transfer for patented technologies not yet existing in the Philippines?

Regulatory harmonization & convergence

What trend involves alignment among major health regulatory agencies to understand the same concepts and definitions?

Reduction of redundancy in regulatory efforts and more efficient resource spending for the private sector

What are the benefits of regulatory harmonization and convergence?

Shift from development aid to free trade agreements

What trend in regulation signifies the Philippines maturing as an economy?

Reversed

What has happened to the shift from development aid to free trade agreements in the last 4 years in the Philippines?

Data-driven medical devices & the internet of things

What trend in regulation generates a wealth of information for regulators and the private sector?

Community as the Object of Public Sector’s Authority To protect and to serve the public/community

What is the purpose of the public sector's authority?

Establishing social safety nets (consumer protection, Universal Health Coverage & Health Financing), patient education and product labeling, electronic commerce

What forms can the provision of public health goods take?

Ensuring that the private sector is responsible and reliable in its dealings with the public, ensuring that people are getting a fair trade

What does consumer protection entail?

Fairness and truth in advertisements

What is important regarding product labeling in terms of public sector authority and regulation?

Safety of trade and individuals through electronic commerce, correction mechanisms for failures in transactions

What does the public sector need to ensure regarding electronic commerce for health products?

Complex problem solving, critical thinking, creativity

What are some necessary skill sets for human resources in the next 5-10 years, according to the World Economic Forum?

Gateway and middlemen

What is the role of professionals in the provision of goods and services for the community?

Money

What lubricates the exchange of goods and services between the community, public and private sectors?

Travel, vehicles, placement in school, shopping, real estate, sex

What forms have incentives taken to manipulate or influence health professionals?

Maslow’s needs hierarchy

What psychological framework's entire hierarchy has been exploited to manipulate health professionals?

To provide goods and services that are sustainable, effective, safe, accessible, and convenient for the community

What is the primary vocation of health professionals when navigating the biopharmaceutical sector?

Elections (suffrage)

For many Filipinos, what is the only way their voice can be heard?

Education

What continues to be the core public good, especially in the face of distorted truth?

Doctors/teachers (Docere = teach)

What is the fundamental vocation of doctors, as highlighted in the source?

Drug Distribution Vast

According to 2018 data, what is the product space of the Philippines for biopharmaceuticals?

Capability distance of biopharmaceutical manufacturing

What does the vast product space illustrate for the Philippines?

Ensure maturity of the economy

Why should the Philippines still pursue the biopharmaceutical industry, despite it being a distant opportunity?

False dichotomy

What is the nature of the question "Which is more urgent for us now—cheap or safe and effective drugs?"

How can we ensure that safe and effective medicines are consistently supplied to Filipinos?

What should the primary focus of legislators be regarding drug supply?

Department of Health’s Medical Assistance Program (MAP), PhilHealth (PHIC), Philippine Charity Sweepstakes Office (PCSO), Local Government Units (LGU)

What are the main government appropriations or entities involved in financing healthcare expenses?

Generates funds through the lottery and sweepstakes

How does the Philippine Charity Sweepstakes Office (PCSO) primarily finance healthcare expenses?

Centralized procurement program of the DOH

What is the Medicines Access Program (MAP) in terms of goods flow?

Consolidate demand and purchase in bulk

How does the DOH's Medicines Access Program achieve cheaper prices for drugs?

Formulation and filling facilities

What are most of the "manufacturers" in the Philippines, given the lack of API production?

Philippine International Trading Corporation (PITC)

What government-owned and controlled corporation purchases medicines directly from sources abroad to provide competition?

India

From which country does the PITC most commonly import cheaper goods?

Z packages and Primary Care Benefits (TSeKaP)

Through which PhilHealth programs are Medicine Access Programs provided?

ComPack for non-communicable diseases (hypertension, diabetes), Expanded program on immunization, Reproductive health, Soil-transmitted helminthiasis

Name at least three types of LGU-based Medicine Access Programs.

Formulary and Essential Medicine

What are the two main drug lists relevant to the Philippine environment?

Formulary

Which drug list is a manual containing clinically oriented summaries of pharmacological information about selected drugs?

Oriented towards what is usable and available to the clinician

What is the orientation of a formulary?

Essential Medicine

Which drug list is created with due regard to disease prevalence and public health relevance?

Oriented towards the needs of the population

What is the orientation of an essential medicine list?

Guide the procurement and supply of medicine costs, medicine donations, and local medicine production

What do lists of essential medicines guide?

Philippine National Formulary Essential Medicines List

What is the name of the combined formulary and essential medicines list in the Philippines?

Used to guide procurement decisions

What is the primary purpose of the Philippine National Formulary Essential Medicines List?

Money (patients buy preferred brands) and Medicine (government purchases in bulk)

What two approaches are being used by the government in providing goods to patients and consumers?

Philippine International Trading Corporation (PITC)

What government instrument competes with local pharmaceutical companies to bring down medicine costs by importing cheaper goods?

Government Procurement & Legislation Local Government Code of 1991 (RA No. 7160)

What law tasked Local Government Units (LGUs) with the authority to provide for the health care needs of their constituents?