IFPMA backs WHO to lead anti-counterfeit fight

The International Federation of Pharmaceutical Manufacturers and Associations today unveiled 10 principles on counterfeit medicines in a bid to "re-focus" the drug industry's stance on the fight against the trade.

A key element of the document is an affirmation of the role of the World Health Organization in leading the international effort against medicines counterfeiting, in the face of a renewed assault on WHO's position as the chair of the IMPACT (International Medical Products Anti-Counterfeiting Taskforce) consortium.

Just ahead of the IFPMA's statement, non-governmental organisations, charities and other groups from around the world sent an open letter to WHO Director General Dr. Margaret Chan indicating that they "are very concerned about the nature and extent of WHO's involvement in issues pertaining to counterfeit medical products."

Once again, the controversy is revolving around the use of the term 'counterfeit', with critics claiming that the definition used by the WHO raises the possibility of confusing counterfeits with generic medicines (see also NGOs fire a broadside at WHO over counterfeits role).

In fact, the tension surrounding the WHO's role in IMPACT has become so taut that the organisation is discussing internally whether it should lead the project - or even pull out - sources close to the organisation told SecuringPharma.com.

The IFPMA document, which is available to download here, lays out IFPMA's current thinking on counterfeiting and seems to be a tacit endorsement of the WHO's leadership in the fight against counterfeiting, which it says is "not about commercial interest; [but] is about protecting patients."

Haruo Naito, president of the IFPMA, said in a statement that the industry group "stand ready to be an active partner in WHO-led efforts, including IMPACT."

IMPACT is the sole global initiative launched by regulators to specifically focus on combating counterfeiting of medical products, according to the IFPMA, and should be supported. It brings together the expertise of medicines’ regulatory agencies, enforcement agencies, healthcare providers and the private sector in a unique global platform.

That sentiment was echoed by Thomas Kubic, chief executive of the Pharmaceutical Security Institute, who revealed some of the PSI's data on counterfeiting from 2009.

"Based on our research, the number of counterfeit medicine incidents worldwide rose almost 7 per cent last year, to 1,693," said Kubic, noting that a particular concern has been the growth in counterfeit anti-infectives, with counterfeit cases in this therapeutic category advancing 50 per cent over the previous year.

Eduardo Pisani, Director General of the IFPMA, commented: “We hope that the Ten Principles will highlight the full scope of the problem and demonstrate that the fight against counterfeit medicines is simply about protecting patients’ health."

The principles are listed briefly below:

1. Medicine counterfeiting is first and foremost a crime against patients
2. Counterfeit medicines threaten the full spectrum of legitimate medicines.
3. Patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents.
4. All substandards are not counterfeits.
5. A medicine that is authorized for marketing by one regulatory authority but not by another should not be regarded as counterfeit.
6. Government regulatory and enforcement authorities must be fully vested with the proper power and adequately resourced to fight counterfeits.
7. Stopping the international trade in counterfeit medicines is vital.
8. All stakeholders across the pharmaceutical supply chain must be made aware of the health threats posed by counterfeit medicines and collaborate.
9. Global cooperation is needed.
10. The leadership of the World Health Organization is crucial.