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