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World Health Professions Alliance (WHPA) Brief to WHO

Member States on Substandard and Spurious/Falsely-

Labelled/Falsified/Counterfeit Medical Products (SFFC)

Health professionals are concerned and call for action

Speaking on behalf of the world’s health professionals1, who are deeply concerned

by the relative inaction on this serious public health threat, WHPA urges WHO

Member States to consider the following:

The infiltration and sale of SFFC medicines in the legitimate supply chain

can cause death and misery to patients around the world. Failure to act to

prevent this would be a fundamental breach of the trust patients place in

public health structures.

In countries with a high burden of communicable diseases such as malaria,

tuberculosis and HIV/AIDS, counterfeit medical products can lead to drug-

resistant forms, which would reverse gains that have been achieved in fighting

these diseases.

Medicines counterfeiting is a worldwide threat to public health and demands

sustained, coordinated international action. The main channels for SFFC

medicine supply include street markets in developing countries and the

Internet. Reported counterfeiting incidents are relatively high in Europe, yet

harm caused by counterfeit medicines is greatest in communities least able to

afford effective regulatory systems and health care.

In sub-Saharan Africa and parts of Asia and South America, people are also

at risk from medicines that may have been accidentally adulterated,

produced to a poor standard and/or degraded by inappropriate storage.

Such problems should not be ignored. But neither should they be confused

with deliberate counterfeiting.

Programmes to protect the public from fake or other seriously defective

medicines should not inappropriately inhibit the supply of low cost generic

medicines that are safe, legal and effective.

1 The World Health Professions Alliance WHPA represents more than 26 million health care

professionals across more than 600 national health professions associations. WHPA is an alliance of the International Council of Nurses (ICN), the International Pharmaceutical Federation (FIP), the World Confederation for Physical Therapy (WCPT), the World Dental Federation (FDI) and the World Medical Association (WMA). By working in collaboration, instead of along parallel tracks, patients and health care systems benefit.

Background

Counterfeit medicines and other health products can have harmful effects on patients' health,

including death in worst-case scenarios. These fake products are also detrimental to public

health efforts to deal with diseases in countries, which are already stretched thin with limited

resources for health care.

The counterfeiting of medicines has been a problem for at least two decades in many countries

around the world. As international markets expand and become globalized the problem has

extended to all countries and regions; even though it remains more prevalent in developing

countries. The increase in the commercial use of the Internet has also contributed to a growth

of the problem as many fake products are sold illegally on unauthorized web sites.

All of us have a common goal to protect the well being of patients in all parts of the world from

poor quality, substandard and counterfeit medical products. Health professionals are taking

pro-active steps in collaboration with Member States and WHO to ensure the quality, safety and

efficacy of all medical products available in countries, in accordance with recognized

international standards. This form of quality assurance applies to both branded and generic

products, to both the private and public sectors, and to both imported and locally manufactured

products.

A lot has been said in many discussions since the first draft resolution on counterfeit medical

products was tabled in 2008. Unfortunately there is still an urgent need for more to be done to

close the gaps.

The 2010 report of the WHO survey on terminology of “counterfeit” medicines in national

legislations clearly demonstrates that regardless of how it is named – as fake, falsified, spurious

or counterfeit – disputes in trademark infringement and other intellectual property related

crimes should never ever be the basis on which to define if a medical product is counterfeit or

not.

Most recently, the Working Group of Member States on Substandard/Spurious/Falsely-

Labelled/Falsified/Counterfeit (SSFFC) Medical Products met from 28 February to 2 March

2011 in Geneva. Reports noted that differences remained among Member States on the

appropriate terms to be used to represent medical products of compromised quality, safety and

efficacy. With regards to the future role of WHO in the areas of substandard and SFFC medical

products, the WHPA supports the three areas of work proposed, namely, information and

awareness creation; setting norms and standards; and providing technical support to countries.

WHPA activities against counterfeiting of medical products

The WHPA “Be Aware, Take Action” campaign www.whpa.org/counterfeit_campaign.htm

provides dentists, nurses, pharmacists, physicians and physical therapists with tools and

strategies to advocate for appropriate investments in the education and capacity building of

health professionals to detect counterfeits and to safely inform colleagues and patients.

The WHPA “Be Aware, Take Action” campaign against counterfeiting of medical products was

officially launched during World Health Assembly in 2010.

One very important recommendation from both workshops is the need for collaboration among health professionals at the national level through the formation of national health professions alliances so that through such inter professional relationships, health professionals can begin to tap from each other’s core competencies in fighting this menace. Through such collaborations, health professionals can then begin to share and learn from their experiences on counterfeit medicines related incidents, make proposals to their government on appropriate policies which define the roles of national associations of health professionals vis-à-vis those of the regulatory authorities where such definitions are lacking. Possible areas of collaboration with the regulatory authorities and intelligence agencies can also be identified. Better systems of drug procurement and medicines distribution as well as models or national systems for reporting cases of medicines counterfeiting can be proposed through such collaboration among health professionals. This will also give room for a collective effort in advocating for an increased government and regulatory authorities’ attention on medicines counterfeiting. Front line health professionals and their patients are directly encountering counterfeit medicines every day. It is our role as professional associations to call upon governments to seriously address this issue.

WHPA regional initiatives with health care professional associations

In the second half of 2010, two ‘Be Aware, Take Action’ regional workshops were conducted for

health care professionals (HCPs). The first was held in Costa Rica (19 October) and the second

in Nigeria (22-23 November).

We estimate that at the end of April 2011 more than 90,000 relevant HCPs and 50 health

decision-makers have been contacted and at least 11 national HCP associations have committed

to on-going anti-counterfeiting activities.

Plans are underway for workshops in the South-East Asia, Western Pacific, Central and Eastern

Europe, Latin America and the Eastern Mediterranean regions in 2011 and 2012.

San José, Costa Rica regional workshop 19 October 2010

53 healthcare professional participants from 23 national health professional organisations and

2 patient groups in 9 countries attended this workshop. At this inaugural meeting, the WHPA

San José Call to Action (annex 1) was adopted by workshop participants. Follow up actions have

since taken place in Costa Rica, El Salvador, the Dominican Republic, Guatemala and Mexico.

More than 20,000 HCPs have been reached as a result of this workshop.

Abuja, Nigeria regional workshop 22-23 November 2010

93 participants from 30 health professions organisations and 4 patient groups in 11 countries

attended this workshop. This represents a reach to more than 65,000 HCPs in these countries.

There was considerable media coverage, the WHPA Abuja Call to Action (annex 2) was adopted

and to date, there has been significant follow up activity by workshop participants in their own

countries. Follow up actions have taken place in Ethiopia, Liberia, Nigeria, Rwanda, Tanzania

and Uganda, and further activities are being planned in other countries who participated in the

workshop.

ANNEX 1

The WHPA San José Call to Action on Combating Falsified and

Counterfeit Medical Products

19 October 2010, San José, Costa Rica

We, health professionals’ organisations from Central America and the Spanish-speaking

Caribbean countries, as well as Colombia and Mexico, have gathered in this first-ever, multi-

disciplinary health professionals event addressing falsified and counterfeit medical products, to

recognize that such medical products present a serious public health problem worldwide, and

to issue this Call to Action to patients, the general public, health care professionals, and

government officials.

We recognize that increased vigilance by health care professionals and patients can help make

safer use of medical products.

We are concerned that falsification and counterfeiting of medical products, including the entire

range of activities from manufacturing to knowingly providing them to patients, is a vile and

serious criminal offense that puts human lives at risk and undermines the credibility of health

systems.

Likewise, we are concerned about the infiltration of such products in the legitimate distribution

chain, leading to the unknowingly prescription, dispensing and administration of such

medicines to patients by healthcare professionals.

Accordingly, we issue this Call to Action to initiate concerted action in our countries:

PATIENTS AND THE GENERAL PUBLIC:

We call on patients and the general public in our countries to:

Only buy medicines from legal outlets, such as registered pharmacies and appropriately

trained personnel such as registered pharmacists

Never buy medicines from illegal or uncontrolled Internet sites that hide their physical

location and are not supervised by properly trained health professionals.

Report a suspected falsified or counterfeit medical product to their attending health

professional.

HEALTH CARE PROFESSIONALS:

We call on health care professionals in our countries to:

Work together across various disciplines to raise awareness of and action against

falsified and counterfeit medical products amongst patients, the general public, their

colleagues and health authorities;

Consider and report falsified and counterfeit medical products as a reason when

patients do not respond or have an unexpected response to treatment;

Always procure medical products from a legitimate distributor or wholesaler.

NATIONAL ORGANISATIONS OF HEALTHCARE PROFESSIONALS

We call on national organisations of health professionals to:

Work together with the other organisations of healthcare professionals in each country

in order to optimise resources, maximise the effectiveness of our efforts and pass on to

the public an image of cohesiveness of healthcare professions around the challenge of

counterfeit medical products.

Work closely with the Pan American Network for Drug Regulatory Harmonization

(PANDRH) / Working Group for Prevention and Combat Drug Counterfeiting, of the Pan

American Health Organization (PAHO).

Encourage their members to take an active role in identifying, reporting and eliminating

falsified or counterfeit medical products from the distribution chain.

GOVERNMENT HEALTH OFFICIALS:

We call on government health officials in our countries to:

Adopt the WHO definition of falsified and counterfeit medical products so that access to

legitimate, safe, effective and affordable generic medicines will not be hindered by

inappropriate intellectual property rights enforcement

Conduct regular public campaigns educating patients and the public about how they can

protect themselves from the dangers of falsified and counterfeit medical products

Establish national reporting systems that enable health professionals to report and to

get feedback about adverse events, drug-related problems, medication errors, misuse or

drug abuse, defects in product quality or detection of falsified and counterfeit medical

products.

The participants2 of this WHPA workshop agree unanimously on the SAN JOSÉ “CALL TO

ACTION” and commit to plan and act in cooperation in support of it.

2 Colombia, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua and Panama

ANNEX 2

The WHPA Abuja Call to Action on Combating Falsified and

Counterfeit Medical Products

22-23 November 2010, Abuja, Nigeria

1. We, national member organizations 3 of the International Council of Nurses (ICN), the

International Pharmaceutical Federation (FIP), the World Confederation for Physical

Therapy (WCPT), the World Dental Federation (FDI) and the World Medical Association

(WMA) are meeting in Abuja, Nigeria on the 22 – 23 November 2010, to address the

alarming threat of falsified and counterfeit medical products in Africa. In attendance, are

patient support and consumer groups4 too.

2. We note with grave concern that the problem of poor quality medicines, particularly

falsification and counterfeiting of medical products is on the increase and that about a half

of medical products in some regions of Africa may be counterfeit.

3. We recognize that significant steps have been taken to fight medicines counterfeiting by

some African governments and their regulatory bodies, health professional organisations

and international organisations such as the World Health Organization (WHO). However,

there remains a need to ensure a zero tolerance to medicines counterfeiting as curbing this

heinous crime is primary to any significant improvements that may be made in the

Millennium Development Goals (MDGs). Health professionals are uniquely positioned in

this fight and must rise up to the challenge to increase the awareness of this problem and

implement definitive strategies towards curbing it.

4. We therefore commit ourselves, as leaders representing nurses, pharmacists, physical

therapists, dentists and physicians, to accelerate our response to this problem by:

a. Empowering patients and the consumers with the knowledge needed to avoid

falsified and counterfeit medicines.

b. Supporting our national drug regulatory authorities and relevant government

agencies to aid pharmaceutical guideline enforcement and by assisting in

developing national reporting systems that enable health professionals to report

and to get feedback about adverse events, medicine-related problems, medication

errors, misuse or medicine abuse, defects in product quality or detection of falsified

and counterfeit medical products.

c. Working with medicines manufacturers, national quality control laboratories,

hospitals and universities to learn about quality products and ways of detecting

3 Cameroon, Cape Verde, Cote d’Ivoire, Democratic Republic of Congo, Ethiopia, Gambia, Ghana, Kenya, Liberia, Nigeria, Rwanda, Tanzania, and Uganda. 4 Liberian United Youth for Community Safety and Development, Association of Women Living with HIV/AIDS in Nigeria, Women and Children Alive, and Community Health and Information Network.

counterfeits as well as provide continuing education programmes to health

professionals on the detection and reporting of counterfeits.

d. Establish inter professional collaboration so that health professionals and patient

support groups can begin to tap from each other’s core competencies in fighting this

public health threat.

5. We strongly urge governments in our countries to:

a. Adopt the WHO definition of falsified and counterfeit medical products so that access to legitimate, safe, effective and affordable generic medicines will not be hindered by inappropriate intellectual property rights enforcement.

b. To implement and enforce relevant legislations and regulations that will prevent, control and reduce the incidence of counterfeit medicines.

c. To strengthen the integrity of the medicines supply, procurement and distribution systems.