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HDA Media And Political Bulletin – 29 November 2016

WHO drops the word ‘counterfeit’ to use the term ‘falsified’ on addressing quality of medicines

29 Nov 2016, Pharmabiz, Ramesh Shankar

 

The World Health Organisation (WHO) has announced plans to replace the current ‘counterfeit’ terminology for the description of low-quality drugs. The WHO will now recommend the use of ‘falsified’ and ‘substandard’ when referring to illicit drugs. The definition of falsified ensures that there will be no confusion over the intellectual property rights of the falsified drugs as well as clarifying that the drugs should not be considered as falsified solely on the grounds that they have not been authorised for marketing in a specific country.

 

This was also reported by Securing IndustryThe Times of India and The Hindu

 

NPA legal action against Government still alive as talks continue

28 Nov 2016, Pharmacy Business, Neil Trainis

 

The National Pharmacy Association (NPA) is still in discussions with its lawyers in regards to mounting a legal challenge against the Government’s plans to cut community pharmacy funding. The Pharmaceutical Services Negotiating Committee (PSNC) recently ruled out challenging the community pharmacy funding cuts through the courts. An NPA spokesperson said that the NPA is continuing to consult with its lawyers until the Government show a shift in their plans for the pharmacy sector.

 

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WHO drops the word ‘counterfeit’ to use the term ‘falsified’ on addressing quality of medicines

29 Nov 2016, Pharmabiz, Ramesh Shankar

 

The World Health Organisation (WHO) has finally distanced its work on addressing the quality of medicines from an IP enforcement agenda. The WHO’s SSFFC working group dropped the word counterfeit and uses the term falsified. Definition of ‘falsified’ further states that any consideration related to intellectual property rights does not fall within this definition. It also clarifies that medical products should not be considered as falsified solely on the grounds that they are unauthorized for marketing in any given country.

 

In fact, India has been fiercely pushing to get the term counterfeit dropped. Dr. V G Somani, Joint Drugs Controller of India, CDSCO, New Delhi represented India in the negotiations.

 

According to sources, the WHO’s Member State Mechanism on substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products adopted the report of the informal working group on the definition. The adopted definition drops the word counterfeit and uses the term falsified – which is much more in line with public health concerns regarding medicines, which make false claims about what they contain or where they are from, that represent a genuine problem.

 

Numerous policy initiatives claim to promote patient safety by taking action against ‘counterfeit’ medicines. But most, if not all, of these initiatives are on the wrong track. In reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality.

 

According to health groups, major US and European pharmaceutical companies have a vested interest in limiting competition from generic drugs, and are using increased enforcement of intellectual property laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries. Confusion around the term ‘counterfeit’ is feeding into this, diverting resources from the real problem of drug quality.

 

People use the term to describe substandard or falsified medicines. But under international law — the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) — the definition of counterfeit is clearly targeted at one particular area: wilful infringement of trademark on a commercial scale.

 

Anti-counterfeit initiatives with this misplaced focus are growing fast. The dangers of this approach are clear. As a result of European customs regulations put in place in 2003 (EC Council Regulation no. 1383/2003), which cover infringements of intellectual property, almost 20 shipments of generic drugs, including basic antibiotics and anti-retrovirals, were detained while in transit from India to several developing countries via Europe in 2008 and 2009.

 

The European Union first claimed it was fighting trade in counterfeit medicines. But an official response by the Dutch government to a Freedom of Information Act request, filed by Health Action International, revealed that these shipments contained generic medicines detained on allegations of infringing intellectual property. Under international law, goods cannot be detained in transit on the grounds of trademark or patent infringement — trademarks and patents are specific to a particular territory.

 

Even the WHO’s attempts to address the issue have been controversial. The discussion on terminology and the confusion it creates has been taken up by the Intergovernmental Working Group on substandard/spurious/falsely labelled/falsified/counterfeit medical products, a body set up by WHO member states.

 

WHO group finally tames fake medicines tongue-twister

28 Nov 2016, Securing Industry, Phil Taylor

 

A World Health Organization (WH) working group has come up with a new lexicon to replace the current clunky nomenclature for illicit and low-quality medicines.

 

For years, WHO has been using the cumbersome phrase ‘substandard/spurious/falsely-labelled/falsified/counterfeit’ medicines or SSFFCs, having got tangled up in an acrimonious debate about the use of the word ‘counterfeit’ and allegations that – as a term associated with intellectual property rights – its use could lead to a conflation with legitimate generic drugs.

 

Now, the WHO’s technical working group has recommended just two words – ‘falsified’ and ‘substandard’ – to cover the gamut of cases under the SSFFC umbrella. The idea still has to be approved by World Health Assembly (WHA) member states, and will come in front of the executive board in May 2017.

 

“The term ‘falsified’ appears to adequately include all the various types of deliberate misrepresentation of a medical product in such a way which enables the specific exclusion of intellectual property rights,” according to the working group.

 

The proposed definitions are as follows:

 

*Substandard medical products – Also called ‘out of specification’, these are authorized medical products that fail to meet either their quality standards or their specifications, or bot; and *

 

Falsified medical products – Medical products that deliberately/fraudulently misrepresent their identity, composition or source.

 

“The terms of reference of the Member State mechanism on SSFFC medical products expressly exclude the protection of intellectual property rights” from the mandate of the member state mechanism for handling falsified and substandard medicines, said the working group.

 

Medicines won’t be called ‘counterfeit’, WHO says

26 Nov 2016, The Times of India, Rema Nagarajan

 

NEW DELHI: In a major victory for India, which has been pushing hard to get the term “counterfeit” dropped from references to medical products, especially generic medicines, the World Health Organisation’s technical working group has decided to drop the term and distance itself from any agenda of enforcing intellectual property.

 

In November 2015, a working group had been set up to refine the working definitions of “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products. The definition adopted by the WHO on Nov 23 dropped the word counterfeit and uses the term falsified – which is said to be more in line with public health concerns regarding the problem of medicines that make false claims about what they contain or where they are from.

 

With this, the WHO has finally distanced its work on addressing the quality of medicines from an IP enforcement agenda. The definition of ‘falsified’ states that any consideration related to intellectual property rights does not fall within it.

 

It also clarifies that medical products should not be considered as falsified solely on the grounds that they are unauthorized for marketing in any given country.

 

Many member states, including India, had pointed out that instead of focusing on the issue of the safety, efficacy and quality of drugs, the use of the term ‘counterfeit’ was diverting regulatory attention to the issue of intellectual property infringement. India has been fighting this battle in WHO since 1992 when the term counterfeit was first included by the world body in references to medical products.

 

A senior official said several government agencies including the commerce and external affairs ministries had been working for over two decades to achieve this. “This is a major achievement for India and for access to medicines for the poor in the developing world,” he said.

 

The European Union claimed it was fighting trade in counterfeit medicines when almost 20 shipments of generic drugs were detained while in transit from India to several developing countries via Europe in 2008 and 2009.

 

A Freedom of Information Act request, filed by Health Action International, had revealed that these shipments were detained on allegations of infringing intellectual property. Under international law, goods cannot be detained in transit on the grounds of trademark or patent infringement as these are specific to a particular territory.

 

This had led to apprehension among groups working on healthcare access in developing countries that major US and European pharma companies were using increased enforcement of intellectual property laws as a tool to clamp down on legitimate trade in high-quality generic medicines between developing countries.

 

WHO settles India, EU medicine dispute

26 Nov 2016, The Hindu, Vidya Krishnan

 

In a significant victory for the global access to medicines campaign, the World Health Organisation (WHO) has dropped the term ‘counterfeit’ and retained ‘falsified’ to describe medicines of inferior quality.

 

The terms were being used interchangeably to confiscated Indian made generic drugs exported to other countries by showing that they were in violation of intellectual property.

 

In a meeting on Thursday, the WHO settled a long standing dispute between India and the European Union (EU) by clarifying that ‘counterfeit’— will now be used by member States with respect to protection of Intellectual Property Rights (IPR).

 

The European Union Free Trade Agreement (EU FTA) had reached a deadlock after affordable, safe-to-use generic drugs made in India were confiscated as ‘illegal’ and ‘counterfeit.’ Nearly 20 shipments of generic drugs, including basic antibiotics and anti-retrovirals, were detained while in transit from India to several developing countries via Europe between 2008 and 2009, derailing the free trade agreement negotiations.

 

Genuine medicines

 

“This decision by the WHO settles a long-standing battle about labelling of drugs. For far too long, genuine generic medicines have been labelled as counterfeit. The confusion had taken away the much needed attention from the substandard medicines — which is a bigger public health problem for developing countries.

 

Additionally, big pharmaceutical companies were using the term ‘counterfeit’ to describe generic medicines and disrupting trade of generic medicines,” said Leena Menghaney, South Asia head of humanitarian aid organisation Médecins Sans Frontières (MSF), which relies on Indian medicines to treat a wide variety of diseases, including tuberculosis, malaria, HIV/AIDS and other infections that afflict the poorest and most vulnerable populations.

 

Clarifying its position, the WHO said in a statement that, “the adopted definition drops the word counterfeit and uses the term falsified — which is much more in line with public health concerns regarding medicines, which make false claims about what they contain or where they are from, that represent a genuine problem.” The decision was taken by a technical working group on draft working definitions of substandard/spurious /falsely-labelled/falsified/counterfeit (SSFFC) medical products met on November 23.

 

The term ‘counterfeit’ was being described substandard or falsified medicines even though, under international law, — the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) — the definition of counterfeit is clearly targeted at one particular area: wilful infringement of trademark on a commercial scale. “In reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality. Major U.S. and European pharmaceutical companies have a vested interest in limiting competition from generic drugs, and are using increased enforcement of intellectual property laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries,” said K.M. Gopakumar, Legal Advisor with the Third World Network (TWN), a transnational policy think tank.

 

NPA legal action against Government still alive as talks continue

28 Nov 2016, Pharmacy Business, Neil Trainis

 

The prospect of the National Pharmacy Association launching legal action against the government over its cuts to community pharmacy funding remains alive after the pharmacy body revealed talks with its lawyers are continuing.

 

Anger within pharmacy over cuts to its budget over the next two years has not dissipated and there has been speculation that somewhere within the profession legal proceedings will start.

 

The PSNC recently ruled out challenging the cuts through the courts but David Reissner, a partner at Charles Russell Speechlys, told Pharmacy Business that he sent a letter to the government’s lawyers on November 16 on behalf of an unnamed client informing them that they consider the government’s decision-making as “flawed.”

 

The NPA has vociferously confronted the government over its pharmacy efficiency measures and legal action from them remains a possibility.

 

“We are consulting with our legal advisors about next steps and we are also continuing with our political activities. We are going to continue campaigning until the government’s direction of travel shifts dramatically,” an NPA spokesperson told Pharmacy Business.

HDA Media And Political Bulletin – 29 November 2016

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