Patients suffer as WHO politics continue

“Counterfeit” is a term that rarely needs defining, and yet controversy erupted again at the recent meeting of the World Health Organization’s Executive Board over just that. 

IMPACT (International Medical Products Anti-Counterfeiting Task Force) – a WHO partnership of major anti-counterfeiting players has recently proposed a new, stricter, definition of counterfeit medicines to help authorities combat this global threat.  While most (85) member countries are in agreement with IMPACTs’ updated definition of counterfeiting, there remain a few dissenters (including India, Argentina, Venezuela, Chile, Brazil and Cuba).  

The WHO currently defines a counterfeit medicine as “a medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”.

IMPACT’s proposed definition includes products with a “false representation of identity, history or source”.  In every public statement on the issue, all parties indicate that they are in agreement that patients around the world should have access to safe and effective medicines.  Why then are they concerned with a strong definition of counterfeiting?

Among the concerns raised over the new definition is the fear that legitimate generic drugs would be treated as counterfeit.  If the medicines are legitimate, then there should be no concerns about their product history or production.

“This is not supposed to be a political game,” said a delegate from Africa according to a recent IP Watch article.  What we need, the delegate added, is funding to increase the capacity of regulatory authorities, to stop the influx of poor quality drugs for which Africa is a “dumping ground.”

What is even more frustrating is that until agreement is reached on the definition of counterfeiting, no coordinated progress is being made on issues such as regulation and enforcement.

If delegates truly want what is best for their citizens, if they truly want them to be protected from counterfeit medicines, then there is no reason to object to a strong definition of counterfeits.  Allow IMPACT to continue its work and for the sake of patients everywhere, let’s work towards stopping counterfeiters in their tracks.

IAPO calls on WHO member states to protect patients from counterfeit medical products

The International Alliance for Patient Organizations (IAPO) — a global alliance representing patients of all nationalities across all disease areas — issued a press release (included below) following the WHO Executive Board meeting calling on member states to protect patients from counterfeit medical products.  To meet this challenge, IAPO stated that numerous factors must be addressed, including weak regulatory systems, inability to afford essential medicines, lack of alternatives and a lack of information.

The full IAPO statement, made at the 124th session of the WHO Executive Board, is available on IAPO’s website.

London, UK, 29 January 2009 – The International Alliance of Patient’s Organizations (IAPO) recently urged members of the WHO Executive Board and member states to protect patients from counterfeit medical products by taking action to promote awareness of the dangers they pose. This request was at the core of an intervention made by Jeremiah Mwangi, IAPO Senior Policy Officer, addressed to delegates at the 124th session of the WHO Executive Board in Geneva, Switzerland.

Counterfeit medical products pose a very real threat to the lives of patients worldwide, and are one of many threats to the quality and safety of medicines available to patients. IAPO believes that the prevalence and availability of counterfeit medical products highlights the gross inequity in access to safe and effective medical products that exists around the world.

To meet this challenge, numerous factors must be addressed, including weak regulatory systems, inability to afford essential medicines, lack of alternatives and a lack of information. Counterfeit medical products are a public health issue. Therefore, IAPO believes that WHO has a central role to play, bringing together relevant stakeholders, including other specialized UN agencies, who can tackle this threat.

In order to protect patients, IAPO made the following call to delegates: “In WHO and member states actions to protect the public from counterfeit medical products, we ask you to not only promote awareness of counterfeit medical products among health professionals, but also among patients so that they can be vigilant and report suspect medicines. IAPO believes that it is essential to take comprehensive and coordinated action to communicate the risks of counterfeit medical products to patients, and to keep patients safe.”

IAPO has prioritised the issue of counterfeit medical products as one of many patient safety issues that are a real danger to patients and, with other patients’ organizations, can make a substantial contribution to partnerships with other key stakeholders. In the role of information provider, IAPO has produced a toolkit for patients’ organizations which includes information to enable patients to identify potential counterfeit medical products and ensure that they acquire medicines that are safe and effective.

The International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that: “Many countries in Africa and parts of Asia and Latin America have areas where more than 30% of the medicines on sale can be counterfeit.” This demonstrates in stark terms the need for political commitment and the full energy of those global institutions, designed to protect and promote public health, to combat this problem. This critical public health issue must not be allowed to slip off the agenda.

The American Autoimmune Related Diseases Association (AARDA) issued a statement of support for IAPO’s global efforts to end the sale and distribution of counterfeit medicines.

The WHO and counterfeit medicines – an unresolved discussion

At last week’s WHO Executive Board meeting, discussion focused on a WHO report and draft resolution on counterfeit medical products.  The International Pharmaceutical Federation (FIP) was one of many health professional associations, NGO’s and other interested groups who joined the discussion.  Their full statement is included below, but some of the key points raised included:

• A common comprehensive definition for counterfeit medical products needs to be in place in all Member States in order to address the negative impact of counterfeit medicines on health; and
• The global and deadly phenomenon of counterfeit medical products will only be eradicated through an agreed framework of effective coordination, cooperation and action at the global level.

FIP intervention on EB124/14, provisional agenda item 4.11 Counterfeit Medical Products:
Speaker from The International Pharmaceutical Federation (FIP) in representing also the World Dental Federation, World Medical Association and the International Council of Nurses

Dear Honorable Members of the Executive Board,

Thank you for the opportunity to speak on behalf of four health professions – dentists, nurses, physicians and pharmacists – which together represent national associations of health professions in more than 150 countries, and bring together more than 25 millions health professionals. 

Following debates arising from the 61st World Health Assembly, in order to address the negative impact of counterfeit medicines on health, a common comprehensive definition for counterfeit medical products needs to be in place in all Member States. We support fully the agreed working text by the WHO International Medical Product Anti-Counterfeiting Taskforce (IMPACT) Third General Meeting and urge all Member States and the international public health community to adopt its principles and to be consistent when establishing and enforcing appropriate legislation and regulations that will prevent counterfeit medical products from being manufactured, exported, imported or traded.

Since the Rome Declaration in 2006, Non-Governmental Organizations such as health professions associations, together with other partners in civil society have called for the consolidation of the most relevant stakeholders in combating counterfeit medical products. We would like to commend the leadership at the WHO for initiating and supporting the work of the IMPACT Secretariat.

Over the past 3 years, IMPACT has developed a number of technical taskforce documents on legislation, regulatory infrastructure and implementation, enforcement, technology development trends and risk communication to combat counterfeit medical products. Some of these practical tools have been useful in the countries that we work in. The International Pharmaceutical Federation (FIP) in representing the World Dental Federation, World Medical Association and the International Council of Nurses, has taken a leadership role in the IMPACT Working Group on Communications and therefore, strongly urges all Member States to support the draft resolution on counterfeit medical products as a reaffirmation of the commitment to prevent and to take all necessary measures to ensure access to genuine quality medical products.

As health professional associations, we assign high priority to promoting awareness among all health professionals and patients of the dangers of counterfeit medical products. In today’s world, digital technology and the Internet make information globally accessible. More and more patients are going online to not only research their own medical issues, but trying to self-diagnose and self-treat as well, based on what they read on the Internet. In some unfortunate cases, unsuspecting patients have died, become sick, or developed a resistance to a genuine antibiotic medicine through the ingestion of counterfeit medical products that contain the incorrect amount of appropriate dose of the drug, harmful additives and no active ingredients at all.

The economic injury of counterfeit goods such as handbags, music and software is significant to individuals, governments and economies; however, it will never compare to the serious public health risks that counterfeit medical products pose. This global and deadly phenomenon of counterfeit medical products will only be eradicated through an agreed framework of effective coordination, cooperation and action at the global level.

On that final note, we thank you for your attention.

Counterfeit medicines and public health: an update from the WHO and on Bill S-799

According to a report from IP Watch, “No compromise has yet been found to bridge disagreements over the consultation process behind the counterfeit report and over the risk of confusing intellectual property violations with potentially dangerous misrepresentation of medicines.” 

As the WHO Executive Board met last week (January 19-27), a World Health Organization report and draft resolution on counterfeit medical products drew energetic debate.   Among the concerns raised were discussions over the precise definition of counterfeiting within the context of the WHO, and procedural discussions over the work of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).  On behalf of the European Union, Hungary said it “actively support WHO’s effort and leadership role in the IMPACT task force,” the US said the group had filled its role of combating counterfeit “exceptionally,” and the UK congratulated the group on its “significant contribution to raising awareness and engaging relevant stakeholders.”

Further discussions will take place at the World Health Assembly in May.

Meanwhile, a bill sponsored by Senator Paul A. Sarlo which would impose increased penalties for counterfeiting if the offense poses a risk to the health or safety of the general public was unanimously approved today by the US Senate Judiciary Committee.

The bill, S-799, would upgrade the penalties associated with counterfeiting offenses when the offenses endanger public health.

“There has to be a different standard when a counterfeiter not only tries to capitalize on a product’s earned reputation, but also ignores health and safety precautions and puts consumers in danger,” said Senator Sarlo. “By itself, counterfeiting undermines a product’s legitimacy, but in cases when the public safety is called into question, we need higher penalties to act as a deterrent.”

The bill now heads to the full Senate for approval.

China warns of more health scares amid slowdown

According to a recent Reuters report, the global economic slowdown could have serious health and safety implications.

BEIJING, Jan 14 (Reuters) – Chinese food and drug makers struggling in a declining economy could be tempted to cut corners and ignore quality standards, a senior Chinese official warned as the country awaits court verdicts in a tainted milk scandal.

China has been rocked by a number of scandals in recent years involving unsafe food and drugs which have sometimes killed people and prompted global recalls of Chinese-made goods.

At least six children last year died from drinking milk formula adulterated with melamine, an industrial compound used to cheat nutrition tests, and more than 290,000 fell ill with kidney stones. China has put on trial a number of company officials and farmers accused of producing and selling the toxic milk.

Shao Mingli, a senior official from China’s food and drug safety watchdog, said that the country was on “high alert” as the impact of the financial crisis began to hit home, Xinhua news agency quoted him as saying late on Tuesday.

“Some enterprises might conduct production in violation of standards and regulations in an attempt to ease their financial burdens,” Shao said.

“On the other hand, conflicts and disputes arising from some companies’ regrouping or merger and acquisition might impact production and quality management,” the official added, calling for tighter supervision of all levels of the supply chain.

The watchdog had dealt with 297,500 cases of “illegal drugs and medical equipment” with a value of about 600 million yuan ($88 million) last year, Xinhua said, in an indication of the seriousness of the problem.

The report comes amid an investigation into a health scare involving a foreign brand of dog food, which local media have linked to the deaths of dozens of pets.

The China Daily on Tuesday said that at least 30 dogs had died from liver complications after eating a brand of dog food which the state newspaper said was tainted with aflatoxin.

The paper quoted vets who said a number of dogs had been diagnosed with liver damage after eating the pet food, and a local supplier that had stopped selling it.

But China’s General Administration of Quality Supervision, Inspection and Quarantine said it had neither approved the food for import, nor had border quarantine units ever allowed its import, Xinhua said, casting doubt over the product’s origins.

In 2007, pet food made with Chinese ingredients tainted with melamine killed a number of dogs and cats in the United States.

New Pharmaceutical Price Regulation Scheme in the U.K. to Encourage Innovation and Access

A new Pharmaceutical Price Regulation Scheme (PPRS) came into effect in the U.K. on January 1, 2009.  The PPRS represents an attempt to balance incentives for innovation with cost and price restraint.  The objectives of the 2009 PPRS are:

• To deliver value for money; securing the provision of safe and effective medicines at reasonable prices;
• To encourage innovation by promoting a strong and profitable pharmaceutical industry;
• To promote access and uptake for new medicines; and
• To provide a stable and predictable market environment.

“The health departments of the UK and the Association of the British Pharmaceutical Industry have a common interest in ensuring that safe and effective medicines are available on reasonable terms to the NHS, and in a strong, efficient and profitable pharmaceutical industry. Such an industry must be capable of sustained research and development leading to the future availability of new and improved medicines in this and other countries.”
              — Department of Health Site

Some of the important new features are provisions aimed at encouraging and rewarding innovation and encouraging the uptake of cost-effective medicines.

Fake drugs and failed governance

The China Post published an interesting commentary on counterfeit medicines and the global response to this serious threat to public health.

The World Health Organization meets in Geneva this week (Monday, Jan. 19) to decide new measures against the exploding global trade in counterfeit medicines — up to a third of all medicines in Africa and a quarter in developing countries overall. While the WHO wrangles over an international treaty and how to define the term “counterfeit,” it is not addressing the real causes, including the failures of dysfunctional governments which prevent genuine manufacturers from protecting their brands. Interpol co-ordinated some 200 raids and seized more than US$6.65 million of counterfeit medicines in November across Cambodia, China, Laos, Myanmar, Singapore, Thailand and Vietnam: the second massive strike in the area in three years. Governments in developing countries frequently promise “crackdowns,” enact new laws, propose stricter punishments and so on — yet counterfeits remain widespread.

Developed countries, by contrast, have counterfeit levels below one percent. Some suggest this is due to strong regulators such as the U.S. Food and Drug Administration (FDA) yet millions of drug consignments pass through U.S. customs every year to 9,000 wholesalers. The FDA does not and cannot monitor all this, so why don’t more counterfeits slip into such a lucrative market?

Part of the answer lies in the foundations that underpin the economies of richer countries such as strong protection for trademarks, which allows consumers to be confident of the origin of products.

Some claim that brands are only important to expensive, patented medicines. The opposite is true. Most medicines consumed in poor and wealthy countries alike are “generics,” drugs whose patents have expired, which should create a thriving market of branded generics, competing not just on price but on quality too. But a lack of respect for trademarks in developing countries means that patients can rarely be certain that the generics they buy are the genuine item: off-patent drugs are among the most commonly counterfeited medicines.

Rich countries’ civil liability law, meanwhile, ensures that injured consumers can obtain redress through the courts, discouraging the production of fakes and those who peddle them.

This can only happen with efficient legal systems, free of corruption or political influence. Sadly, the courts and police of most developing countries are a long way from this ideal and they allow criminals to bribe their way out of trouble, making new laws futile.

Extra laws often simply create extra layers of bureaucracy which then create further opportunities for corruption. Drugs passing through customs, for example, face myriad regulations and tariffs, inevitably leading to “informal” payments to speed up the process. If the market is small, as in many African countries, many suppliers of legitimate medicines find the obstacles too expensive and do not bother supplying at all. Counterfeiters, unconcerned by regulations, gain even greater advantage. A free media is also crucial to improving standards and defending citizens against fakes. In China melamine contamination killed four infants (and harmed thousands), yet the government banned news reporting. All three cases filed against the producer have been rejected by the courts. The same happens with medicines.

Additionally, many governments impose high taxes and tariffs as well as complicated regulations on imported medical products, adding an average of 68.6% to the final price in developing countries, according to a WHO study in 2003: taxes or tariffs alone are often around 20% – from 14% sales tax in South Africa to a combined 30% in Brazil and more than 50% in India for imports (and at least 19% on local drugs). This makes real drugs more expensive, creating yet more opportunities for counterfeiters to undercut them.

Although strengthening the rule of law is vital for tackling fake drugs, as well as for general economic development, such reforms are lengthy and difficult. In the short-term, technology can help manufacturers of genuine products protect their brands. In Ghana, a new service called MPedigree allows people to send serial numbers (embedded under a scratch-pad on drug packets they have bought) by text message: they then get a message back telling them if the item is genuine. Many similar schemes are under development. Even safe Taiwan, with only around one percent counterfeits, has had to introduce near-infrared spectrography (NIR) to protect consumers.

The WHO and its International Medical Products Anti-Counterfeiting Taskforce (IMPACT) are doing good work in publicizing the threat and pushing governments to react but the private sector has to be at the forefront of solutions, especially in developing countries: after all, it has a far better grip on drug production, storage and distribution. Governments can help by interfering less, taxing less and focusing on what would really help, like strengthening the rule of law.

Julian Harris and Philip Stevens are analysts at International Policy Network (www.policynetwork.net), London, an international, non-governmental, educational and non-partisan development think-tank.

TACD meeting on Patents, Copyright and Knowledge Governance

The Transatlantic Consumer Dialogue recently hosted a meeting in Washington D.C. on Patents, Copyrights and Knowledge Governance.  Panellists were charged with making 2-3 concrete policy recommendations re IP for the incoming Obama administration.  While no consensus was reached, and in fact only a few of the presenters actually provided specific policy recommendations, there were some interesting presentations and discussions.  Some of the points raised include:

• Maintaining an innovation economy is central to America’s long term success.
• Innovation should be high on the government agenda.  There is a need for an advocate for innovation in the Whitehouse. 
• Having a patent system is good, though everyone can agree that it can be improved.
• Implement different IP requirements and protections for different industries (software and IT technologies don’t take 20 years to develop and also become obsolete much faster)
• University generated invention is a huge source of innovation

Other topics raised during the two-day meeting included the need to improve access to affordable and effective medicines in developing countries; the potential benefits and significant challenges a prize system to induce innovation; TRIPS flexibilities and US trade practices; and the Anti-Counterfeiting Trade Agreement.

TACD is a forum of US and EU consumer organisations co-chaired by Jill Johnstone of Consumer Focus and James Love of KEI.

Backgrounder on compulsory licensing

The Council on Foreign Relations recently posted an interesting article which discusses global trade rules for intellectual property in the context of access to essential medicines.  The following is a brief overview of the article: 

In 1995, members of the WTO ascribed to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which established minimum levels of protection for member countries for products including pharmaceuticals.

WTO members were also given flexibility in how to establish their patenting systems, which allowed them to issue compulsory licenses to produce generic versions of products, including drugs, without the permission of the patent holder under circumstances such as a national emergency. But this flexibility has led to a lot of controversy. Do Hyung Kim of the University of the Houston Law Center in February 2007 says in a research guide on TRIPS that the problem is “any nation can, in theory, declare a public health emergency for questionable reasons to assign compulsory licensing for any patented drug.”

By the turn of the century, a number of emerging economies threatened to issue compulsory licenses just as they would have come under TRIPS jurisdiction, primarily as a tool in drug price negotiations.

Some experts are concerned that the inclusion of noninfectious diseases, such as cancer, diabetes and heart disease, into this little- or no-profit scenario could undermine innovation for chronic diseases, because there would be few profit avenues left for pharmaceutical companies. “Somebody’s got to pay, there’s no free lunch,” argues Fidler. With the investment climate so competitive, R&D money for a product likely to be “immediately stolen” by countries breaking patents could be a difficult sell to investors.

Read the full backgrounder at the Council on Foreign Relations site.

Incentives for Research into Neglected Tropical Diseases

One of the many topics that have been discussed in the wake of the WHO’s intergovernmental working group on public health, innovation and intellectual property, is the issue of incentives for research into neglected tropical diseases.  Over the past decade, many public-private partnerships, government programs and other initiatives have fostered medical research into diseases primarily affecting developping countries and strengthened regional healthcare infrastructure.  While more can always be done, it is also important not to jeopardize existing programs.

The Center for Global Development’s Global Health Policy blog discusses one promising new incentive scheme — The Priority Voucher Review:

…the PRV program, it is a new bipartisan incentive mechanism passed by Congress and signed into law in September of 2007. The legislation rewards the sponsor of a neglected tropical disease product with a tradable voucher upon its FDA approval. The voucher can then be used to obtain a priority (speedier) review for another product.

…

MSF argues that big pharmaceutical companies will abuse the legislation, scouring their pipelines and dusty shelves to register existing products they had no prior plans for. This is a flawed argument. The legislation specifically excludes combination therapies (where any active ingredient has previously been approved been FDA approved), and it will only award a PRV for a product that is either a significant improvement over the current treatment, or where no current treatment exists. This is why Novartis is the only company to come forward and apply for FDA approval thus far. It should also be noted that there are not dusty shelves full of neglected disease products; in fact, there are too few products for neglected diseases – exactly why this incentive was created. Even if companies did come forward with these hypothetical, existing products, the vouchers would be a well deserved reward for investment in neglected diseases.

…

No incentive scheme will be perfect, but the PRV program is an innovative mechanism to increase this much-needed R&D in neglected diseases. It is a unique way for the US to use its own market-based, profit oriented business model for the good of the developing world, and the U.S. Congress should be commended for this farsighted legislation.

Read the full article on the Global Health Policy blog.