HDA Media And Political Bulletin 17 May 2016
|The UN’s Misguided Focus on Patents as the Cause of Drug Shortages
15 May 2016, IP Watchdog, Joseph Allen
IP Watchdog discusses patent protection as a barrier to improving access to medicines in developing countries. The article is in advance of the U.N. Secretary General’s High-Level Panel on Access to Medicines report on the patent system, which is expected to cite patents as one of the larger pieces of the problem. Companies such as Biotechnology Innovation Organization have pointed out that although 95% of essential medicines are off patent, one third of the world’s population still does not have reliable access to them. The article points out the cost of producing drugs and concludes by stating that blaming the patent system for access problems is destructive.
16 May 2016, The Pharmaceutical Journal
The Department of Health (DH)_H has announced reductions worth £48m to Category M (generic medicine reimbursement) prices which will apply to prescriptions between June and September 2016. This is in response to the preliminary findings of the 2015/16 medicines margin survey. The DH intends to reclaim excess margin worth £800m that they believe was delivered to contractors in 2015/16.
16 May 2016, PSNC
The Department of Health granted the following price concessions for May 2016:
The price concession only applies to the month that it is granted.
Contractors will be alerted to any updates through our website and via our e-news email. If you wish to subscribe to our email list, you can receive an email as soon as any announcements are made. Please note that PSNC cannot provide details of generic products that are suspected of being affected by generic supply problems unless and until the Department of Health grants a concession. No additional endorsements are required for price concessions.
If you have problems obtaining a Part VIII product or problems obtaining the product at the set Drug Tariff price, please report the issue to PSNC using the online feedback form on the PSNC Website.
If you have been able to source the product, please provide full details of the supplier and price paid. PSNC will investigate the extent of the problem and if appropriate discuss the issue with the Department of Health.
Any further concessions will be posted here on the website.
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|The UN’s Misguided Focus on Patents as the Cause of Drug Shortages
15 May 2016, IP Watchdog, Joseph Allen
A growing drum beat tuned for the election year is advising the government to override patent protection as the quick and easy way to make drugs more accessible. The patent system is being roundly condemned as a barrier to public health which must be brought to heel. Efforts range from urging the NIH to misuse the march in provisions of the Bayh-Dole Act to control drug costs to “A simple way for government to curb inflated drug prices“ in The Washington Post advising that the “government patent use” authority be invoked to take drugs deemed too expensive. The next step in the campaign is coming from the United Nations.
Improving access to needed medicines for those suffering the ravages of disease in developing countries is a serious issue. There are many factors contributing to the problem including poor transportation systems, lack of available health care and education, endemic poverty, trade barriers, systematic corruption and, of course, the cost of drugs. Yet the U.N. Secretary General’s High-Level Panel on Access to Medicines is focusing on the patent system as the source of the problem. The report is due next month.
The Panel received predictable statements from both sides of the debate, with one notable exception. The U.S. Department of State undiplomatically pointed out the crucial flaw in the study: ” We question the premise that the rights of inventors, international human rights law, trade rules, and public health are “misaligned”…
State offered a devastating indictment:
The Panel has been tasked with examining only two pieces of the larger puzzle, and will be doing so in isolation, pursuant to terms of reference which are based on a description of the problem stated in a way that suggests predetermined outcomes. The United States is concerned that by conducting such a narrow review, the report issued by the Panel may be imbalanced and of limited use, or even counterproductive in building consensus among stakeholders and national governments.
The Panel’s recent press release “Protests, Patents and Patients Dominate Debate In Johannesburg” shows that the Department’s concerns are justified. According to the release, the Panel is to “address the policy incoherence between intellectual property laws and access to medicines.” Participants praised several “alternatives and/or changes to the current patent based system” being considered. One of the “new ideas” prominently cited is having government, not industry, pay for R&D. “This means no monopolies on medicines that are financed with public money. In order to realize this, we need to find a way to work together as a global community so that all governments will contribute fairly to developing R&D costs.”
It’s hard to think of a worse idea than putting a consortium of governments in charge of drug development–unless it’s putting the UN in charge.
The statement from the Biotechnology Innovation Organization illustrates why the focus on intellectual property as the source of the problem misses the mark:
At the outset we note that the scope of the call for contributions appears to be narrower than the apparent mandate of the Commission. In fact, the call presupposes that the concept, and advances that notion that IP protections are inconsistent with public health. We disagree with this assessment and we believe that the facts prove this assertion to the contrary. For example we note that while 95% of essential medicines, as defined by the WHO, are off patent, still one third of the world’s population does not have reliable access to them and, in parts of Africa and Asia, that is true for half the population. And despite all the current mechanisms in place to facilitate no-or-low costs access to non-patented HIV medicines, only 15.8 million of the estimated 36.9 million people living with HIV globally (about 43%) were accessing treatment in 2014.
Moreover, despite the wide availability of no-or-very low cost non-patented HIV medicines, in at least 14 African countries, 80% or more of people who were estimated to be eligible for treatment under the WHO guidelines were not receiving antiretroviral therapy as of 2013. First-line treatments for killer diseases like malaria and TB are available as generic products at very low cost, and yet many people are denied access to them. And finally, according to the WHO, and estimated 649 million people, or about 50% of the population in India do not have regular access to the hundreds of non-patented drugs on India’s EML. Despite its large domestic generic drug industry, India’s investment in health as a percentage of its GDP has averaged around 4% for the last decade. India’s current level of 4.5% is one of the lowest figures in the world ranking it below such countries as Haiti and Ethiopia.
The solution to these problems isn’t destroying the system the world depends on for creating new drugs. And it’s not an accident that most come from the United States.
Drugs are only made in a handful of countries with strong patent systems. The reason is simple: the costs and the risks of bringing a new drug to market are enormous. If you’re looking to get rich quick, drug development isn’t for you. Developing a drug takes more than 12 years, costing an average of $2 billion per drug. For every 5,000 drugs tested, perhaps 5 will proceed to clinical trials, and one may reach the market. Of these, perhaps 20% will turn a profit, and they must pay for the whole system. This effort can only be justified if resulting products are patent protected so they cannot be freely copied around the world. And unlike other countries, many of our new drugs come from small companies and start ups. Patents are crucial for them to receive risk capital and to compete against well established competitors.
The US enjoys an unparalleled university and federal laboratory research system, an important source of new treatments. However, publicly funded inventions are more like ideas than products. The task of turning these discoveries into drugs that can alleviate human suffering falls on the private sector, which spends many times in development what the government spent supporting the underlying research. If the product is unsuccessful, the company alone takes the hit. Without a strong patent system, no business can afford to assume this burden.
Before passage of the Bayh-Dole Act, federally funded drug discoveries simply wasted away in the laboratory, benefitting no one. It’s no coincidence that after Bayh-Dole injected the incentives of the patent system into the process that federally supported inventions suddenly became drivers of new therapies, new companies and even a new industry– biotechnology– in which we lead the world.
Blaming the patent system for the problem of access to drugs is more than misguided, it’s destructive. The poster boy of bad behavior, Martin Shkreli, who raised the cost of Daraprim 5000% overnight wasn’t using the patent system for his misdeeds. Shkreli knew that rival companies would not go through the lengthy, expensive FDA approval process for a drug with a limited patient population. When the UN launches a study on the costs of regulation, please let me know.
The Department of State offered some important points to ponder:
The High-Level Panel’s mandate is too narrow to address the many and often inter-related barriers to access to safe, effective, and affordable medicines. The World Health Organization (WHO) identifies four main factors contributing to access to medicines: l) the rational selection and use of medicines, 2) affordable prices, 3) sustainable financing, and 4) reliable health and supply systems. None of these factors are being directly studied by the Panel. With regard to affordable pricing of medicines, the WHO has identified numerous considerations, including pricing and procurement policies, taxes, markups and tariffs, and other national policies (or lack thereof) that ultimately result in higher costs for consumers and for health systems.2 In fact, even common, essential, off-patent medicines often do not achieve their intended health impact due to supply and manufacturing issues…
State “strongly” advises the UN to “incorporate all relevant factors into a meaningful analysis of why people in low and middle income countries do not have the access to medicines that we all believe is desirable and necessary.”
Good advice. Let’s hope it’s taken. It’s advice we should incorporate into our own debate on how to make important new therapies more accessible for those who need them.
16 May 2016, The Pharmaceutical Journal
The government is clawing back £48m from community pharmacy contractors in England over the next four months, with the possibility of more cuts after October 2016, national negotiators have revealed.
The reduction in reimbursement prices for generic medicines listed in Category M of the Drug Tariff — £12m a month from June 2016 to September 2016 — is a move by the Department of Health to reclaim an overpayment to contractors above the agreed allowance of £800m in 2015–2016. The department plans to consider future funding in October 2016 in discussion with the Pharmaceutical Services Negotiating Committee (PSNC), the negotiating body for community pharmacy contractors in England.
The PSNC acknowledges that the Category M margin levels were high in 2015–2016 year but rejects the cut in reimbursement.
The announcement is a further financial blow to community pharmacists in England and comes as the PSNC admits it is making little progress in persuading the government to drop its planned £170m cut to the 2016–2017 pharmacy budget.
Peter Cattee, chair of the PSNC’s funding and contract sub-committee, says ministers have little interest in commissioning additional services from community pharmacy.
“The government appears unshaken in their determination to remove a sum of £170m from community pharmacy funding this year, and to do so via reductions in fees and allowances.
“We are very pessimistic about the outcome of the consultation on community pharmacy’s future,” he adds. “We are also very concerned that the NHS and government have not been clear about their aims… We strongly advise all contractors to make whatever provisions they can for the funding reductions.”
Meanwhile, Community Pharmacy Scotland, which represents community pharmacy owners in Scotland, has secured an extra £1m for the profession in 2016–2017 following successful negotiations with the Scottish Government.
16 May 2016, Pharmacy Biz, Neil Trainis
Misleading comments by Dr Keith Ridge to the All-Party Pharmacy Group on dispensing error rates in Sweden and England continue to cause ripples, with Gareth Jones, head of corporate affairs at the National Pharmacy Association, urging him to “go further” to ensure “a fair representation of the error rate literature” is presented.
Jones (pictured) criticised Ridge, the chief pharmaceutical officer, for relying on a research paper by professor Bryony Dean Franklin, executive lead pharmacist research and director at the Centre for Medication Safety and Service Quality, which put the dispensing error rate in community pharmacy in England at 3.3%.
“In advance of the APPG hearing I spoke to Bryony who confirmed that in her view 3% remains about the dispensing error rate in community pharmacy, taking into account methodologies and definitions used, although there remains a paucity of good research,” said Dr Ridge, who had attempted to make a comparison between dispensing error rates in community pharmacy in England and large scale automated dispensing facilities in Sweden.
Dr Ridge also corrected his dispensing error figure made to the APPG of 0.00001% in relation to large scale automated dispensing facilities in Sweden.
“I was referring to the error rate published by Apotekstjanst AB in Sweden – in fact the published rate is 0.0000185%,” he said.
Acknowledging Dr Ridge’s apology for “inadvertently misleading” the APPG, Jones said: “We understand that the chief pharmaceutical officer has accepted that he misled the All-Party Pharmacy Group in relation to safety data for hub and spoke models. The Department of Health’s hub and spoke proposal is flawed and this is just one of many claims that are unravelling.
“But he still needs to go further in order to ensure that the APPG and anyone planning to respond to the consultation has a fair representation of the error rate literature.
“It is interesting that he relies on just one of the papers (by Bryony Dean Franklin which provides the 3.3% error rate) from the K. Lynette James literature review.
“The authors in the James et al. paper reviewed this paper by Bryony Dean Franklin and stated ‘the data-collection procedure employed by Franklin and O’Grady was inconsistent. . . . . the validity, reliability and reproducibility of study findings are compromised.’
“Those significant criticisms of the research should, we believe, have been declared to the APPG. The number of items checked within the Bryony Dean Franklin study was less than 3,000 (and only 11 pharmacies were involved).
“Another UK study mentioned in the James et al. paper, with a much lower error rate (0.04%), sampled 125,000 items. Why has he ignored these other studies when presenting an error rate to the group?
“And why has he not addressed the point that the DH used the 0.04% figure in its February 2015 decriminalisation impact assessment? (the Department of Health clearly believed that was the most reliable evidence).”
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