Medicine Pricing

CHE by factor of health care provision

Drug management cycle

selection

procurement

distribution

rational use

UHC Law, Philippine National Formulary

Generics Act

RA12009:New Government Procurement Reform Law

Cheaper Medicines Act

Warehousing

Pharmacy Law

in govt hospital, if there is a certain drug that is usually used, pharmacotherapy committee will talk about the usage of that drug -> will try to place the drug in the formulary; if not, topic nomination to the HTA

Management Support

electronic logistics management information system (LMIS)

unified supply chain information system to address current PSCM (Procurement and Supply Chain Management challenges

DOH procuring entity

Medicines management in the public sector

national (DOH)

local (Provincial/municipality/city)

local (municipality/city/barangay)

public health drugs (vertical programs, Medicine Access Programs (MAPs))

specialty care (hospitals)

primary care (PCFs)

the DOH medicine access programs (MAPs) refer to government programs that guarantee access to certain medicines to a particular group or segment of the population

relatively new in terms of logistics of medicines in the Philippines; it tries to be more efficient

breast cancer medicine access program

complete treatment pack program

medicine access program for mental health

public sector procurement

new goverment procurement reform act

purpose:

current state: lack of product selection standards, lack of quantification of guidelines and national committee, long procurement lead time, warehouse management gaps, adhoc distribution mechanisms, lack of inventory policy across all level, lack of data standards and master stock keeping unit list, fragmented systems, and lack of supply chain data visibility

probles

Future state: integrated procurement framework available, cost effective, uniform warehouse management, synchronized distribution and reverse logistics, master list of inventories or stock keeping units (SKUs), end-to-end supply chain data visibility, and integrated information system

generics act

purpose: use of pharmaceutical generic names among all government agencies and personnel "in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines'

EO No. 49 s. 1993 mandated the use of the PNDF in all public procurement, effectively limiting the medicines that may be procured by government entities

cheaper medicines act

imposition of maximum retail price through the office of the president

drug price reference index mandates the procurement price ceiling of essential medicines in DOH facilities, and expanded to all government medicine procurement

Framework Agreement (Sec 16, RA12009)

price regulations

parallel importation

maximum retail price

serves as an understanding between procuring entities and suppliers, stipulating how to conduct business for a predetermined duration

drug price reference index

government-mediated access price (GMAP) list

goods produced genuinely under protection of a trademark, patent, or copyright, placed into circulating in the market, and then imported into a second market without the authorization of the local owner of the intellectual property right

an arrangement between one or more buyers and multiple suppliers, defining the terms under which individual contracts, or call-offs, can be made during the life of the agreement - sets the groundwork for the future award of contracts, without guaranteeing volume or spend

parallel imports emerge where international price differences exceed the costs of transporting and selling medicines across two countries

aims to achieve savings and efficiency by aggregating demand and streamlining the tender process

AO 2020-0039

imposition of maximum prices at all levels of the supply chain, including, but not limited to, manufacturer's price, trader's price, distributor's price and wholesaler's price, and retailer's price

generic drugs

accdg to the generics act: to create the market competition

bioequivalence

drug price advisory council

use of generic terminology

composed of public health, epidemi9ologu, pharmacuetical policy,law, clinical, and economic experts to provide technical advice and guidance to the DOH in implementing measure to promote and ensure access to affordable quality drugs and medicines for all consumers in the Philippines

domestic manufacturing

generic drug importation

education on use of generic drugs

members of the council shall be co-terminus with the SOH subject to reappointment by the new SOH

the biochemical similarity of two (or more) drugs that share the same active ingredient(s) and desired outcome(s) for patients

chair of the council shall hold his/her position not exceeding three years unless he/she relinquished his/her position for reasons beyond his/her control

AO 2015-0051

criteria

The maximum procurement price of essential medicines across all government facilities and government agencies except in cases where the previous years' procurement is lower than the set DPRI of DOH

recommended medicines, based on qualifying criteria evaluation

medicines for top burden of diseases

medicines with limited competition

Set ABC* at the level of previous years' procurement with an allowable variation of plus 10% to account for inflation

EO No. 155 imposing MRP on 34 drug molecules or 71 drug formulas

used to guide all national and lcoal government health facilities in the efficient sourcing of pharmaceutical products in the public sector

external reference pricing

all drugs listed in the PNF

practice of using the price(s) of a pharmaceutical product in one or several countries in order to derive a benchmark or reference price for the purposes of setting and negotiating the price of the product in a given country

*Approved Budget for the Contract - budget for the contract duly approved by the head of the procuring entity

innovator brands and drugs with limited competition (less than 4 manufacturers)

basket of countries

asian countries: Thailand, Malaysia, Vietnam, India, Indonesia

lowest bid price or through external reference pricing (ERP) with countries of similar income status

developed countries: UK, Australia, Canada

calculated every year based on prevailing procurement prices of medicines in govt health facilities with sources from

Regional DOH offices

MRP = MWP + mark-up

DOH retained hospitals

Central Office Bids and Awars Committee (COBAC)

advisory council resolution 2009-001

PITC Pharma, Inc (PPI)

voluntary price reduction of selected drugs and medicines by pharmaceutical companies

no medicine under the GMAP reduction scheme shall be sold at a price exceeding those reflecting in the GMAP list

SC/PWD Discount

lack of APIs and there are economic downturn; hence, expensive drugs

senior citizens and persons with disabilities are entitled to a 20% discount and VAT exemption (12%) on retail medicine purchases

drugs came from india, and pakistan because there ingredients are cheaper which drives the domestic manufacturer to close down

VAT exemption

Effect of Pharmaceutical Policy on Drug Prices

TRAIN Law

expanded the list of VAT-exempt transactions to include sale of drugs and medicines prescribed for diabetes, high cholesterol, and hypertension, which helps reduce their retail prices

The MRP, market entry of generic medicines, VAT exemption and market entry of new originator drugs DO NOT SIGNIFICANTLY AFFECT DRUG PRICES in the PH

CREATE Law

provided value-added tax (VAT) exemption to certain health products including, drugs for hypertension, cancer, mental illnesses, tuberculosis, kidney diseases, diabetes, high cholesterol and covid 19 medicines and medical devices

Generic Medicines

has the potential to decrease drug prices if enough competitors are found in the market through local manufacturing and parallel importation

Maximum Retail Price

There is a need to revist ERP and MWP/MRP formula

VAT exemption

need to study medium- and long-term effects of VAT-exemption

drug price reference index (DPRI)

required for DOH hospitals/DOH-retained hospitals

Cost driver for healthcare

Wages of healthcare professionals

required for other government agencies but not as strict

Cost of facilities

Cost of healthcare services

maximum retail price (MRP)

executive order released from time-to-time from the office of the presdient

gives the list of molecules that are subject to the MRP

medications belong to the formulary of an institution

medications that can be part of formularies in government institutions should be part of the PNF

requires medications bought should be generic

Pharmaceuticals

highlighted that we have different additional procurement methods

20-25% every year for medicine, vaccines and health technologies.

Other health care goods

. This law revises the previous Government Procurement Reform Act (RA 9184) to enhance transparency, competitiveness, efficiency, accountability, and value for money in public procurement processes in the Philippines

It aims to ensure that national and local government health facilities can source pharmaceutical products at fair and reasonable prices

Other materials and services used

includes the supplier to the facility and distribution within the facility

medicines are a major cost-driver

Domains in accessing medicines

Availability

Affordability

Geographic accessibility

Quality

Rational Use

RA 11223, RA6675, RA9502, RA7432/9994 Expanded Senior Citizen Act, RA 7277/10754 Expanded Benefits and Privileges of PWD, RA 10963 TRAIN Law, RA 11534 Corporate Recovery and Tax Incentives for Enterprises Act

RA11223, RA9711

Relevant laws: DOH AO 2019-0036: F1 plus bnb

RA6675, RA9184, RA 11223

proper prescribing, dispensing, and patient use

procures it for itself (phase of distribution), then transfers it to various institutions

drug therapeutics committee

aka Pharmacy Therapeutics Committee

discusses and includes a commonly used medication in the formulary

The procurement law requires that there should be a Project Procurement Management Plan (PPMP) which includes all medications that need to be purchased in a year.

If a medication is already included in PPMP, the hospital/LGU can request

bidding process (RA 9184)

pre-procurement conference

advertisement

pre-bid conference

eligibility screening

submission and opening of bids

bid evaluation

post-qualification

award of contract

contract signing and implementation

importance: gives guidance and structure, resource optimization, transparency and accountability, risk management, compliance, efficiency and effectives

The procurement opportunity is advertised to invite potential bidders. This ensures that the process is open and competitive

procurement requests

PhilGEPS

Philippine Government Electronic Procurement System

A meeting is held to clarify any concerns or questions from prospective bidders regarding the procurement requirements23.

Typical process: Verification (if the medication is listed in ppmp approved) -> Requisition (request to the procurement office, specifying the medication and required quantity) -> Approval (procurement office reviews the request) -> Procurement process -> Distribution

Prospective bidders are screened to ensure they meet the necessary qualifications and requirements

Bidders submit their proposals, which are then opened in a public session to maintain transparency

opening of 1st envelope

eligibility bid security, NFCC,Technical Proposal

opening of 2nd enveloped

financial proposal

The submitted bids are evaluated based on pre-determined criteria to determine the most advantageous offer for the government

The bid that appears to be the most advantageous is further scrutinized to verify the bidder’s capability and compliance with the requirements23.

The contract is awarded to the bidder who meets all the requirements and offers the best value for money23.

PROCESS

Delivery of drugs -> receiving and inspection (QA) -> inventory management -> internal distribution -> monitoring and replenishment -> reporting and accountability

challenge

isang beses lang priprocure ang drugs sa isang tao -> expiry

Depends on what kind of service delivery you are trying to provide whether public health, specialty care and primary care

resources

capacity building of people who will using it

lack of warehouse -> masisira ang mga gamot

In reality, BHS do not follow the proper procurement process

technical working group is required in bids and awards committee that are related to those procured by the committee

should be knowledgeable to the medicines being procured

types of procurement

public-bidding

negotiated agreement

We communicate w/ the supplier beforehand, which can be used in public bidding. Example: we have 10 suppliers for metformin. We can communicate with them and have an agreement and procure throughout the year instead of just one-time.

simplified screening and qualification processes

introduces price-ceilings and capped price adjustments post-award

standardized procurement processes and forms

This can be done without a framework agreement but without this agreement, the supplier can only get their payment once all materials have been delivered to the government

institutionalized civil society participation

adopted open and competitive bidding as primary mode of procurement

mandated the use of an electronic procurement system to ptomote transparency and competition

importance of framework agreement is to ensure available pool of suppliers, we can buy medicines from time to time

inconsistent in compliace to GPRA process

ex. gov set price of 150k for computer and specs are provided (even the specs is not worth the price)

If there is no framework agreement, the bid winner will only be paid once they have delivered the goods

difficulties in access and use of the government procurement system

barangay lvl should be registered in PhilGEPS

Let's say we have a 1 year agreement, 5000 tablets were requested. The purchase request states that we will request for delivery of a certain amount depending on the need later on. No promised number of medicines and supplier is paid by initial delivery

limited in monitoring and enforcement mechanisms

e.g. overpriced computers

Problem: In govt, dapat muna matapos yung contact bago mabayaran. Kaya nabblacklist ang govt offices kasi matagal pa bago mabayaran kahit andiyan naman ang pera

requires generic name instead of brand name

problem with DPRI

sets the price based on the year before

problem if the DPRI is lower -> failure of bidding

economies of scale

if smal -> the have to buy small quantities -> more expensive but they have to base the price on DPRI

because of generics act law, it causes the most significant decrease in price

procurement spending is bigger in LGUs than DOH

stems from situations where importing is more economically cheaper than manufacturing the drug in the country

set the prices of different levels of supply chain because as medicines move in the supply chain, prices inevitably increases due to markups

example during covid, this is to increase access to medicines

since the medicines are transferred to different stakeholders -> price increases once it reaches the patient

The ABC is already set in the purchase order

PPMP contains equivalent price per good or services

sets the price for the MRP and procurement of DOH of the HT

Purchase order contains price per piece and how many pieces will be bought

DPRI should be the price per piece, but the problem is procurement price from last year that is consolidated then will be the price of DPRI for this year

meet the market authorization holder to negotiate price

Does not account for inflation and public health emergencies

Oftentimes, the price set by the supplier is already, which makes it hard for them to lower based on the price of the DPRI which becomes the problem

patented medicnes need to ahve a set price to avoid expensive drug pricing

set a price cap to prevent extermely high pricing

internal reference pricing

entails the comparison of teh drug price within the Philippines

Another problem is that most LGUs dont know the existence of DPRI. They randomly set prices

Maximum wholesale price

rate/price paid by a hospital when buying medicines

lowest between median of asian countries, and minimum of developed countries

sets only maximum allowable prices of medicines procure by the govt, which helps prevent overpricing but does not directly influence market competition or consumer behavior

assumes that asian countries are the same

reason why we can't use the cheapest price for asian countries

COA does not able to flag such activities

maximum retail price

rate/price paid by the patient when buying medicines

mark-up adjustment (MUa) depends on MWP value

DPRI provides benchmark prices for products, which helps in setting realistic and competitive ABC for procurement of medicines. By referencing the DPRI, procuring entities can ensure that they procure medicines at reasonable prices.

in the case of low access medicine

developing countries are given prioritity

but not always the case as the presence of a price regulatory board and an established HTA

EU countries

sabay sabay pagprocure -> low price

unlike in the PHL -> decentralized -> more expensive

Price/1.12*80%

talk to marketing authorization holder to lower the price (especially for medicines for cancer, mAbs, and other costly medicines)

through Pharmaceutical and Healthcare Association of the Philippines (PHAP)

Problem: for the retail price lang nawalan ng VAT, not on distribution and transport, in return, yung retailer yung nababawasan ng 12% yung pagbebenta

GMAP list shall be made available in all pharmacies and shall be seen by the customers

the price shall be lower or the same as GMAP, but not all medicines are in GMAP, only the expensive ones

voluntary price reduction through negotiation between DOH and pharmaceutical companies, especially for medicines for cancer, mAbs and other expensive medicines

Which means there is indirect cost increase due to the overall increase in excise taxes on fuel and other goods which indirectly raise operational costs for pharmaceutical companies which might be passed on to consumers in the form of higher prices for non-exempt drugs

primary care medicines are benefitted by this; how about those for specialty care that is less accessible

in distribution and transport, there is increased in fuel costs which has contagion effects on operational costs leading to an increase of prices in medicines

the only way to reduce the price of these medicines is through MRP

price before and after vat exemption did not change

retailers and wholesalers will increase their mark-ups

RA12009