Leading up to the release of Professor Joe DiMasi's latest study of the cost of drug development, KEI offered $50 to the individual who could most accurately predict the new cost for drug R&D.
We received 26 guesses, ranging from $1.157 billion to $5 billion.
Joel Lexchin's estimate ($2.47 billion) was the closest to DiMasi's number ($2.558 billion). It was also the 5th largest estimate.
A complete list of submissions is below.
Name & Guess
Charles Clift - 1.157 billion
Nicole H - 1.2 billion
Ronald Rader - 1.55 billion
Wouter Deelder - 1.655 billion
The Tuft Center for Study of Drug Development (CSDD) has just concluded a press conference, and issued a press release about their new study of drug development costs. The key number is $2.558 billion.
When the new Tufts study on the costs of R&D for development of a new drug is released Tuesday at 10AM, here are 10 things to look for:
We will be sharing some data on 2005 to 2014 oncology approvals, including the size of the trials cited in the medical review, and the orphan status.
The spreadsheet we are working on updating is published here:
KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
A copy of the research note is also available here as a pdf file: http://keionline.org/sites/default/files/kei-rn-2014-3.pdf
KEI Research Note 2014:3
Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
November 17, 2014
Here you can find the slide presentations given at the event “Can we afford our medicines?” that took place on November 12th, 2014 at the European Parliament. The webstream of the whole event is here: http://greenmediabox.eu/en/ct/62-Can-we-afford-our-medicines- . Thanks to all who made the event a big success and we hope it will be a turning point in the fight for universal access to quality health treatments in Europe.
CAN WE AFFORD OUR MEDICINES?
Notes from introduction to “Can we afford our medicines?” event in EP, 12-11-2014
1. Transparency: Today there is no transparency on prices EU states pay for medicines(taxpayers often don´t know what their state health service is paying for each medicine), no transparency on scientific research/clinical trials or safety and efficacy, nor on R and D costs nor is there clear traceability of the costs of producing a new medicine, We´re in the dark, middle ages. Doctors don´t know, Patients don´t know, Politicians don´t know, Taxpayers don´t know.
2. How many times do we pay? Three is a massive privatization of public investment in research. “I already paid for this drug!” is a reality. Where is the public return on investment in research if there are there no strings attached to our investment as far as IPR, affordability or knowledge exploitaiton? We often re-buy taxpayer research at an astronomical cost and end up paying for a medicine 3,4 or 5 times (taxes, co-payment, medical insurance, tax evasion of pharmaceutical companies, paywalls around public research results, ..)
3. Public Good, not just a commodity: Health is a public good, health knowledge is a public good, part of the global commons. Is access to medicines mainly a competitive business issue or a public health question?
4. Is the present system efficient? Marketing costs dwarf research, most new drugs have little therapeutic value (me toos, evergreening), cost of not sharing data of clinical trials, overprescription and underprescription are two sides of same coin. Safety and efficacy of medicines are often hidden. There is great over-lap and waste in research, marketing and deception.
5. Corruption or unethical practices are massive: Pay to delay practices to prevent generics on market cost public health systmes billions. Massive perks for doctors, unethical lobbying by paid pseudo patient groups, massive tax evasion by big pharma (where is the so called “trickle-down” benefit for all?) and thousands of lobbyists in Brussels that work to place pharma profits ahead of affodable public healh needs.
6. Monopoly and Malice: Patent monopolies do not fuel innovation but often prevent it- thickets, scientific enclosure, fear of sharing, scientific manipulation. In Energy and Telecom: measures for structural unbundling of dominant positions have been proposed or taken in market in favor of consumers, competition and lower prices; but EU patients have no such advantage. There are clear dominant positions in the pharma market: Direct or indirect control of R and D, production, IPR portfolios, marketing and sales- end up moulding and manipulating of whole cycle.
7. It is the EU´s competence!: It is often said that health and pharmaceutical pricing are not direct EU competences but indirectly they are. Fiscal austerity, Transparency, IPR policy, EU innovation and research, non-discrimination..
8. Evidence based EU policy: No econometric studies on different innovation models No impact evaluation of EU promoted austerity cuts in health budgets, No provision of how Europeans will pay skyrocketing medicines expenditures of an aging population and more expensive drugs, No EU project to share health technology assesments. No price caps considered, No socially responsible licensing proposals for EU research..
9. De-linkage and open source dividend: Separate R and D costs from final costs of medicines through prizes, patent pools and open medical research. Fund an open source dividend to incentivize sharing of scientific research. Promote socially responsible licensing when public money is involved.
10. If it is not good for the majority, it is not good. Marginal costs of producing medicines are very low, universal access is possible if there is political will to break monopolies. Access is the best policy: If it doesn´t work for the majority, it simply doesn´t work.
The problem of unaffordable medicines and the need for health-driven innovation are not on EU agenda
Due to the high cost of medicines, millions of citizens of EU member states cannot receive proper medical treatment for a number of very serious illnesses. Practically half of the EU population is excluded from the most effective treatments for cancer, Hepatitis C and other life-saving medicines simply because they (nor their public health systems) cannot pay for them. Despite this fact, there is no clear political reaction to this situation, not even an organized debate nor a coherent search for policy proposals, studies or pilot programmes. Surprisingly, this situation is rarely considered a political and moral scandal. Health inequality is not usually considered any less acceptable than general social inequality. Unfortunately, EU supported austerity measures that have forced health-care budget cuts have made this bad situation even worse.
After many meetings this week with the health attachés from a number of important EU member states that are members of the Council´s working groups on pharmaceuticals and public health, I have reached the depressing conclusion that to date initiatives on the price of medicines and new health-driven innovation models are practically non-existent in the institutional sphere. None of the major EU member states recall ever having discussed any innovation or pricing alternatives to the Pharma patent monopoly driven model. This is in a context in which a number of these same countries admit that their states either cannot afford to buy some of the best life-saving treatments or they are forced to ration them to a small percentage of the patients who need them.
It is surprising that while there are legal EU price caps on telephone roaming rates and data roaming, no one proposes controlling prices of life-saving medicine prices. And it is not just a question of competences but of political will to place health first ahead of the dominant “growth, jobs, innovation” rant.
While there have been some political and parliamentary rumblings that complain about the high price of some medicines, namely the Hepatitis C cure Sovaldi, there are no concrete, viable proposals on the official political table that could bring down the price of life-saving medicines and/or promote new biomedical innovation models driven by real health needs. On the contrary, there are a number of serious proposals on the EU short-term agenda (medicine price Directive, TTIP, greater IPR protection, “personalized, innovative medicines”..) that could even make it more difficult in the future to bring down the price of medicines or introduce health-driven innovation models.
“Access to medicines” is usually understood by the European Commission, EU member states and other policy makers as meaning making new products “available for patients”, getting them “on the market” or “over the regulatory hurdles”, never about being affordable. Aside from some occasional rhetorical, lip-service about patients needs, pharmaceuticals is seen primarily and secondarily as issue of “growth, jobs and industrial innovation” rather that a public good. No one at all contests the constant official EU equivalency of stronger, longer patent protection and data exclusivity with “innovative medicines” nor objects at all to the coupling of high medicine prices with the high research costs of a new generation of “personalized medicine”. There is no consideration of protecting the “public return” of massive public investments in biomedical R and D nor preventing the privatization of public health-related knowledge. The pharma mantra is so pervasive that often European Commission officials from DG Enterprise, DG Research and DG Sanco are “more catholic than the Pope” in defending industry orthodoxy on IPR, transparency and high prices. A rather minor example: the EU policy to promote “open data” research with EU finding has just excluded any research related to health because it would be “too controversial”. The ideological, regulatory and legislative capture by the pharmaceutical industry is almost complete in Brussels with very few exceptions such as the inconclusive, partial victories such as the Regulation on clinical trial transparency.
A few issues now on the table in the EU Council and in the European Commission:
Joint Procurement: France has proposed pooled procurement solely to purchase Hepatitis C treatment Sovaldi. It is not at all clear if this will ever materialize. A number of countries have shown an interest in this initiative but there is a reluctance to share information and many countries such as Spain or France itself have gone on to negotiate secret agreements with the company Giliad on their own. The success of this initiative is very doubtful because of the lack of openness.
Transparency of prices: The Directive on medicine prices (now being considered by the Council) is all about the Pharma industry having access to government procurement processes and health technology actions in each EU member state so the Pharma industry can be able to take action against the lowering of prices on “innovative medicines”. It is not at all about the publication of the real prices each member state pays Pharma for medicines. These procurement prices are kept secret. As a result, the pharmaceutical industry knows perfectly well the prices and conditions negotiated by each European state while each government negotiating prices is totally in the dark about the prices paid by neighboring European countries. By “divide and conquer” the industry is at a great advantage in negotiating prices.
TTIP and pharmaceuticals: like everywhere else, the pharma wish-list – all oriented to market-driven innovation, high prices and higher IPR protection is very present at the negotiating table for both EU and US negotiators.
On 14 March 2014, KEI published "Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules" in which we provided an analysis of the Global Fund's plans to create a global framework for tiered pricing enforced by the rules of the World Trade Organization (WTO).
WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentiality
6 November 2014
The following intervention on patents and health was delivered by KEI during the 21st session on WIPO's Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.
Statement of Knowledge Ecology International (KEI)
Item 7: Patents and health
On Wednesday, 5 November 2014, Pakistan delivered the following intervention on patents and health.
Agenda 7 Statement on patents and health
1. General statement
I will make this statement in national capacity,
WIPO Standing Committee on the Law of Patents (SCP 21): Intervention of Pakistan on Opposition Systems
On Tuesday, 5 November 2014, Pakistan delivered the following intervention on opposition systems.
The agenda item on quality of patents also include another item on "opposition systems" which was not discussed by the Committee. I want to make a small statement on opposition systems.
WIPO patent committee (SCP21) to discuss International Nonproprietary Names and Exceptions and Limitations to Patent Rights
In the words of the International Bureau of the World Intellectual Property Organization (WIPO), the WIPO Standing Committee on the Law of Patents (SCP) was created,
created in 1998 to serve as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law.
WTO TRIPS Council (October 2014): Statement of India on the Review of the Paragraph 6 system (compulsory licensing for export)
On 28 October 2014, India delivered the following intervention at the WTO TRIPS Council's annual review of the Paragraph 6 system (designed to facilitate compulsory licensing for export of pharmaceuticals).
In particular, India noted that
Obama officials seek end of WIPO program on limitations and exceptions to patent rights in developing countries
During the WIPO 2014 General Assembly's discussions of patents and health in the context of the work of the Standing Committee on the Law of Patent (SCP), the Obama Administration embraced an aggressive position against WIPO technical assistance on the use of patent limitations and exceptions.
India's Department of Industrial Policy and Promotion creates IPR Think Tank to Draft National IPR Policy
On Friday, 24 October 2014, India's Department of Industrial Policy and Promotion (DIPP) announced the creation of an IPR Think Tank to Draft National Intellectual Property Rights Policy.
The composition of the think tank follows:
Justice Prabha Sridevan, Chairperson, IPR Think Tank;
Ms. Pratibha Singh, Advocate, Singh & Singh Associates, Member;
Ms. Punita Bhargava, Advocate, Inventure IP, Member;
Dr. Unnat Pandit, Cadila Pharmaceuticals Limited, Member;
My name is Elizabeth Rajasingh.
I want to talk about a trade dispute between India and the United States, involving patents on a drug for leukemia.
New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishers
For more information:
James Love, Knowledge Ecology International
email: email@example.com, +1.202.361.3040
The May 16, 2014 version of the consolidated negotiating text for the Intellectual Property Chapter for the Trans-Pacific Partnership (TPP) agreement is a long, complex document that taken as a whole is designed to expand and extend monopolies on knowledge goods, including in particular publisher-owned copyrights, patents on inventions, and monopoly rights in data used to register new drugs, vaccines and agricultural chemical products.