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Corruption and Pharmaceuticals: Strengthening Good Governance. Health, Nutrition & Population, Human Development Network, Operations   Policy and Country Services and                                       PREM Public Sector Group                           Brown Bag Lunch Seminar April 4, 2006

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Corruption and pharmaceuticals strengthening good governance
Corruption and Pharmaceuticals: Strengthening Good Governance

Health, Nutrition & Population, Human Development Network, Operations   Policy and Country Services and                                       PREM Public Sector Group                           Brown Bag Lunch Seminar

April 4, 2006

Washington, DC

Jillian Clare Cohen, Monique Mrazek and Lorraine Hawkins


Organization of seminar
Organization of Seminar Governance

  • Introduction to the topic

  • Provide examples of how corruption can occur globally

  • Highlight a pharmaceutical diagnostic tool applied in Costa Rica

  • Discuss anti-corruption strategies

  • Feedback


Introduction
Introduction Governance

  • Access to medicines is often a life and death issue

  • Despite international aid and a plethora of programs devoted to improving global pharmaceutical access, there is a morally concerning drug gap

  • About 2 billion people or one-third of the global population lack regular access to medicines

  • WHO estimates that by improving access to essential medicines (and vaccines) about 10 million lives per year could be saved

  • Corruption contributes to the drug gap


The impact of corruption in the pharmaceutical system
The Impact of Corruption in the Pharmaceutical System Governance

  • Corruption in any one of the critical decision points in the pharmaceutical system can be detrimental to a country’s ability to improve the health of its population

  • Typically the poor in developing countries are most susceptible to its detrimental effects

  • Good governance is a sine qua non for ensuring good access to essential medicines for the population


Why the pharmaceutical system is susceptible to corruption
Why the Pharmaceutical System is Susceptible to Corruption Governance

  • The sale of pharmaceutical products is lucrative

  • Final customers more vulnerable to opportunism than other products

  • Pharmaceutical suppliers (drug manufacturers, importers, wholesalers, pharmacists) are profit maximizers

  • But sometimes profit maximization breaches legal norms and professional ethical norms


Good governance
Good Governance Governance

  • We focus on two core areas for good governance

  • First, government regulation (e.g. market entry, manufacture, sale)

  • Second, when coverage is provided, selecting, purchasing and managing distribution of medicines


Why the pharmaceutical system is susceptible to corruption1
Why the Pharmaceutical System is Susceptible to Corruption Governance

  • The pharmaceutical system has a significant degree of government involvement in its regulation

  • Government officials have a monopoly on several core decision points

  • Governments determine how drugs are selected for a national formulary

  • Need robust institutional checks and oversight mechanisms to limit individual discretion


Why the pharmaceutical system is susceptible to corruption2
Why the Pharmaceutical System is Susceptible to Corruption Governance

  • Third, it can be difficult to distinguish authentic pharmaceutical products from counterfeit or sub-standard ones

  • In many countries with weak institutions, the sale of counterfeit, unregistered or expired drugs are common

  • The WHO estimates that about 25 percent of drugs consumed in poor countries are counterfeit or substandard

  • Counterfeiters are often skilled at copying legitimate products


Corruption is now talked about

Corruption and pharmaceuticals is becoming a “mainstream” topic

Reluctance in the past by policy makers to disregard the issue

“Too complicated”

“I’ll know it when I see it”

“How can you distinguish the difference between corruption and inefficiency?”

Corruption is now talked about


Collective action to fight corruption
Collective Action to Fight Corruption “mainstream” topic

  • Declaration of Rome (February 2006)

    “…counterfeiting medicines, including the entire range of activities from manufacturing to providing them to patients, is a vile and serious criminal offence that puts human lives at risk and undermines the credibility of health care systems”


Counterfeit medicines the bad and ugly
Counterfeit Medicines: the Bad and Ugly “mainstream” topic

  • If institutions weak more likely find counterfeit medicines in the market

  • Regulators may receive kickbacks to ignore makers of counterfeits

  • Regulators may be intimidated by counterfeit producers


Counterfeit medicines 2
Counterfeit Medicines (2) “mainstream” topic

  • Thailand, substandard medicines account for 8.5 percent of the market

  • China had 500 illegal manufacturers

  • India plans to introduce the death penalty


Counterfeit medicines 3
Counterfeit Medicines (3) “mainstream” topic

“Profiting from spurious drugs that might harm or kill innocent people is equivalent to mass murder”

  • Tragedies are not uncommon (e.g. Haiti and cough syrup for children)


Global examples
Global Examples “mainstream” topic

  • A pharmaceutical manufacturer in Brazil was found to be manufacturing sub-standard contraceptive drugs

  • In June 2004, the New York State Attorney General’s Office accused GlaxoSmithKline of fraud by concealing information to physicians about the adverse impact of the anti-depressant Paxil® (paroxetine) when prescribed for depression in children and adolescents


Drug dumping
Drug Dumping “mainstream” topic

  • This happens when pharmaceutical companies donate low quality, ineffective or even dangerous drugs to developing countries

  • Tax concessions are given for donations in the USA

  • Need to ensure intention is good and uniform standards apply

  • WHO Guidelines for Drug Donations (1996)


Purpose of corruption framework
Purpose of Corruption Framework “mainstream” topic

  • The pharmaceutical system is technically complex

  • It is comprised of a number of core decision points: manufacturing, registration, selection, procurement, distribution, and prescribing and dispensing

  • Need to know what are the best practices in the core decision points so ignorance and ioster corruption

  • Decision makers need to be familiar with the potential areas where corruption can occur in the pharmaceutical system


Pharmaceutical system corruption assessment tool
Pharmaceutical System Corruption Assessment Tool “mainstream” topic

  • First methodology done by Cohen, Cercone and Macaya (2002) in Costa Rica and which has been revised and applied in South East Asia by the WHO in 2005

  • Includes use of questionnaires that are designed to assess the vulnerability of each decision point in the pharmaceutical system

  • For example, does the pharmaceutical system run centrally or locally? What institutions are involved in the procurement of pharmaceuticals? What committees are responsible for the drug selection process?


Pharmaceutical assessment tool
Pharmaceutical Assessment Tool “mainstream” topic

  • Built on Klitgaard’s formula:

  • Monopoly(M) + Discretion (D) – A (Accountability) – T (Transparency) = Corruption


Service “mainstream” topic

Delivery

Manufacturing

Selection

Registration

Procurement

Distribution


Methodology “mainstream” topic

Gaining Support

We obtained support from the central government and the hospital management prior to launching our pilot study in order to guarantee access to information

Evaluation

Evaluation

indicators

indicators

Develop

Develop

Seek “buy

Seek “buy

-

-

in”

in”

General

General

questions /

questions /

and mandate

and mandate

methodology

methodology

Focus groups

Focus groups

distribute to

distribute to

from top

from top

design

design

decision points

decision points

leadership

leadership

User survey

User survey

Map questions

Map questions

to key

to key

personnel

personnel

Request

Request

support from

support from

Contact and

Contact and

hospital

hospital

meet with key

meet with key

management

management

personnel

personnel

Focus groups

Focus groups

User survey

User survey

Collect industry

Collect industry

Collect

Collect

(must have good

(must have good

(train survey

(train survey

perspective

perspective

information

information

moderator)

moderator)

collectors)

collectors)


Assessment tool continued
Assessment Tool (Continued) “mainstream” topic

  • After interviews complete, indicators are rated according to the specified criteria

  • An average rating is calculated for each of the questions addressing a given decision point

  • Average rating has a possible range from zero to one

  • Sum of all the ratings of one is divided by the number of questions in a given decision point to obtain the percentage indicators

  • Resulting percentage is converted to a zero-to-ten scale by multiplying the resulting percentage by ten


Methodology “mainstream” topic

Scale

A ten-point rating system represents the following degrees of vulnerability to corruption:

0.0 – 2.0

2.1 – 4.0

4.1 – 6.0

6.1 – 8.0

8.1 – 10.0

Extremely vulnerable

Very vulnerable

Moderately vulnerable

Minimally vulnerable

Marginally vulnerable


Some findings costa rica
Some Findings: Costa Rica “mainstream” topic

  • Procurement was moderately vulnerable to corruption, with a relatively low rating of 5.7.

  • Absence of an information system to track suppliers and project future need, as well as the lack of documentation

  • Distribution was 6.9, due to the absence of a monitoring system for inventory stock


Some findings costa rica1
Some Findings: Costa Rica “mainstream” topic

  • Registration and selection processes both received 9.4, indicating that they are minimally vulnerable to corruption

  • System received an overall rating of 7.7 suggesting the system is only marginally vulnerable to corruption


Nigeria s war on counterfeiters 1
Nigeria’s War on Counterfeiters (1) “mainstream” topic

  • Nigeria notorious source of counterfeit medicines

    • Studies found more than 50% (up to 80%) of retail drugs sampled were not compliant with pharmacopeia standards

    • Some had no or a small amount of active ingredient (50 mg ampicillin instead of 250mg), others were mislabeled (for example paracetamol labeled as the antimalarial drug Fansidar)

  • New head of National Agency for Food and Drug Control (NAFDAC) declared war in 2001

    • Staff retrained

    • Procedures more transparent

    • Registration guidelines updated and enforcement strengthened with more inspectors


Nigeria s war on counterfeiters 2
Nigeria’s War on Counterfeiters (2) “mainstream” topic

  • Drugs seized in markets, manufacturers, warehouses

  • Drug stores and sub-standard manufacturers closed

  • Media campaign to out fake drugs and smugglers

  • Impact:

    • estimates of up to 80% fewer fake drugs on market

    • 30 convictions secured and 40 pending

    • Some West African countries lifted ban on Nigerian drugs

    • Local manufacturers experiencing turnaround with 16 new manufacturing sites

    • Multinationals coming back to Nigeria

  • Lessons: Make example of smugglers; inspections and enforcement incentive to retailers; education and training including of general public key


Unregistered drugs azerbaijan
Unregistered Drugs Azerbaijan “mainstream” topic

  • Central Drug Control Laboratory modernized and staff retrained

  • Regular batch testing of drugs

  • Drugs passing inspection had hologram stickers on package

  • Hotline for patients to check if a batch number had passed quality control

  • Number of arrests and seizures of unregistered drugs


Drug procurement albania
Drug Procurement Albania “mainstream” topic

  • In Eastern Europe rapid deregulation and privatization of pharmaceutical sector, combined with unstable economic and political environment created vulnerabilities to corruption

  • Procurement system was vulnerable to influence during drug selection, kickbacks or bribes that enabled bidders access to confidential information and use of direct procurement instead of competitive bidding

  • Albania has made significant strides introducing a more transparent international tendering system

  • This has significantly lowered the price of the average purchase contract for a given drug


What can we do
What Can We Do? “mainstream” topic

  • Klitgaard (2000) identifies three main phases in combating corruption

  • First raise consciousness: Educate decision makers and the public about corruption and its deleterious impact

  • Second add systems analysis to identify points of vulnerability to corruption

  • Third determine what prevention strategies are necessary to prevent corruption


What to do manufacturing
What to Do: Manufacturing “mainstream” topic

  • Ensure legal basis for GMP requirement

  • Ensure compliance with GMP by having both regular and random inspections

  • Hire a sufficient number of capable and well paid inspectors

  • Develop a rotating schedule for inspectors of manufacturing sites


What to do drug registration and quality control
What to Do: Drug Registration and Quality Control “mainstream” topic

  • Develop transparent, effective and uniform law and regulations for drug registration

  • Ensure adequate quality control capacity or capacity to adequately review registration documents

  • Educate professionals and public to identify registered drugs

  • Disseminate information on internet

  • Market surveillance and random batch testing


What to do drug selection
What to Do: Drug Selection “mainstream” topic

  • Clear criteria for selection and pricing

  • Drug selection criteria should be based on international standards as set out by WHO

  • List based on WHO EDL

  • Committee membership available publicly

  • Professional and public scrutiny including the regular reporting to the media of drug selection meetings

  • Public posting of methodologies used and results obtained/decisions made


What to do procurement
What to Do: Procurement “mainstream” topic

  • Procurement procedures must be transparent, follow formal written procedures throughout the process and use explicit criteria to award contracts to reduce the risk of corruption

  • Announced closing date should be strictly adhered to

  • Information on tender process and results should be made available to all participants and published

  • Supplier selection justified and monitored

  • Written records should be kept of all bids received

  • Procurement office should be required to report regularly on key procurement performance indicators


What to do distribution
What to Do: Distribution “mainstream” topic

  • Where possible develop information systems to ensure drugs are allocated, transported and stored appropriately at all points

  • Tight and regular communication and reporting between every level of the system

  • Appropriate storage facilities and conditions

  • Good security such as electronic monitoring of transport vehicles and careful checking of delivery orders against inventories of products delivered


What to do prescribing and dispensing
What to Do: Prescribing and Dispensing “mainstream” topic

  • Where possible use information systems to monitor physician prescription patterns

  • Impose serious penalties for breaches of legal and ethical standards

  • Regulate industry interaction with prescribers through explicit criteria that limit industry gifts and payments

  • License and inspect pharmacies


Closing thoughts
Closing Thoughts “mainstream” topic

  • The methods and recommendations we make are not comprehensive or perfect

  • They are however a needed first step to confront corruption head-on

  • Education and transparency are key

  • Once we know where corruption is likely, deterrent measures can be put in place

  • This should include putting together baseline data

  • Disregarding the problem is not an option


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