Public Citizen, National Physicians Alliance, Other Civil Society Groups Write Letters in Support of California AB 463
In addition to the numerous groups and institutions that stood in support of AB 463 (Pharmaceutical Cost Transparency Act of 2015) at the California Assembly Health Committee hearing on April 21st, six civil society groups that we are aware of have submitted letters or statements in support of the bill.
In alphabetical order, these include:
1. American Medical Students Association (AMSA)
2. National Council of Asian Pacific Islander Physicians (NCAPIP)
3. National Physicians Alliance (NPA)
4. Public Citizen
5. Universities Allied for Essential Medicines (UAEM)
KEI Notes on California Assembly Health Committee Markup on AB 463 Pharmaceutical Cost Transparency Act of 2015
Yesterday (April 21,2015) the California Assembly held a Health Committee hearing to discuss various bills being offered, including Assembly Member Dan Chiu's AB 463, titled the Pharmaceutical Cost Transparency Act of 2015.
AB 463 calls for the pharmaceutical industry to annually report its costs for developing and manufacturing a drug (for any course of treatment over $10k). The bill seeks to provide audited information on R&D costs, a topic for which the industry often makes unsupported and exaggerated claims.
KEI Seminars on Drug Pricing: 30 April 2015, Prof. Paul Grootendorst on the Canadian approach to drug pricing
On Thursday, 30 April 2015, KEI will host the first talk in a series of seminars on drug pricing. The seminars will take place via video conference (hosted by KEI), and participation is welcome either by attending the presentation at KEI’s Washington, DC offices, or to the extent we are able, joining the digital conference.
I would like to call your attention to the plenary debate on the ratification of the Marrakesh Treaty that will take place next session in Strasbourg, probably on April 29th. We would like to ask you to request speaking time or to participate through the “catch the eye” procedure to support the EU´s swift ratification of the Marrakesh Treaty. This would back the demands of millions of blind persons and other visually impaired people in favor of the right to access to reading material in accessible formats.
Please find below a short explanation and suggested speaking points for the debate.
Thank you in advance for your support,
European Blind Union
Speaking points for MEPs for Marrakesh Treaty debate in the European Parliament: Please support in plenary the right to read of blind and visually-impaired persons!
Since the international agreement reached on the Marrakesh Treaty nearly two years ago it is not acceptable that the EU and its member states have yet to make any progress toward the ratification and implementation of this important international human rights tool for the access to culture of millions of blind and visually impaired persons. . We are deeply concerned and disappointed that due to a lack of consensus building, technical-legal commitment and political will on the part of EU member states time has been unduly wasted.
Why we need the Treaty?
We are suffering a “book famine” because fewer than 5 percent of the books published in Europe are available in a format which is accessible for blind and low vision readers while the books that are available cannot be shared across borders in Europe and the rest of the world where fewer than 1% of the books published are available for visually-impaired persons. This enormous lack of accessible mother tongue and foreign language literature deprives blind and partially sighted people of their right to education, information and social participation. EU ratification of the Marrakesh Treaty will help overcome the existing barriers of national copyright laws in order to facilitate the cross-border flow of specially formatted works for visually-impaired persons.
What the European Blind Union asks for:
The European Blind Union strongly opposes the attempt by the Latvian Council Presidency to suspend the ratification process by the EU of the Marrakesh Treaty. This would greatly delay the effective entry in force of the Treaty and the facilitation of access to culture of millions of blind persons in Europe and around the world.
The European Blind Union rejects any attempt to include the Marrakesh Treaty in the general debate about the future of copyright in the EU. Former Commissioner Michel Barnier committed himself publicly on behalf of the European Commission for Marrakesh ratification not to be mixed up with the EU´s new copyright framework. This Treaty is a specific issue of basic human rights for persons with disabilities that should not be delayed for many years by mixing it up with very different issues.
If the Council is convinced that new legislation is needed for implementation(though Council and Commission legal services now do not agree) the EBU asks the Council to present a written position on the legislative changes it deems necessary to EU legislation so as to avoid unnecessary disagreements and delays in the future. These should be drafted in close consultation with blind person’s representatives and their organizations to assure that the objectives of the Marrakesh Treaty are not weakened or changed in anyway by new EU legislation. Even if legal changes are needed later, the EBU asks the EU and its member states to proceed now to ratify the Treaty.
The EBU calls upon the Commission and the Council to adopt a time table which indicates the time frame for the ratification and implementation of the Marrakech treaty.
The EBU asks the European Parliament, the Commission and the Council to establish three-way informal “trialogue” consultations to reach an agreement on the swiftest way of assuring ratification and implementation of the Treaty.
Yesterday, Politico published this story:
Leaked digital single market’s ‘evidence file’ reveals Commission’s ambitions. Documents show policy came before evidence for cybersecurity measures.
By ZOYA SHEFTALOVICH 20/4/15, 1:29 PM CET Updated 21/4/15, 11:33 AM CET
WIPO CDIP 15: Statement of Brazil on evaluation of the Project on Open Collaborative Projects and IP-Based Models
On Tuesday, 21 April 2015, the 15th session of the World Intellectual Property Organization's (WIPO) Committee on Development and Intellectual Property (CDIP) considered the Evaluation Report for the Project on Open Collaborative Projects and IP-Based Models (CDIP/15/3). This project on open collaborate development models is based on Recommendation 36 of the WIPO which states,
The California Assembly Health Committee has published an analysis of AB463, the Pharmaceutical Cost Transparency Act of 2015. The bill will be marked up by the committee on Tuesday (April 21). The analysis was written by Dharia McGrew. It recommends three amendments to the bill, and provides a discussion of the benefits of the required disclosures, with context, and describes the support and opposition. The staff report is attached, and below is a list of 33 groups supporting and 22 opposing the bill.
Knowledge Ecology International (KEI) will present the following statement on 20 April 2015 to the Open Session of the 20th Expert Committee on the Selection and Use of Essential Medicines.
Statement of Knowledge Ecology International: WHO 20th Expert Committee on the Selection and Use of Essential Medicines, with specific focus on expanding access to new cancer drugs, when available at affordable prices
20 April 2015
Dear members of the WHO Expert Committee and the WHO secretariat,
State of California considers AB463, a bill to require disclosure of drug development costs, and more economic data
This is a bill that will see legislative action next week in California, and the bill has some momentum. This is the first time I have seen any government make an effort to have useful data on the economics drug drug development and pricing, and it provides a model that other governments may want to built upon.
A mark-up on the bill has been scheduled for Tuesday, April 21, 2015, in the Assembly Health Committee.
BILL NUMBER: AB 463
INTRODUCED BILL TEXT
INTRODUCED BY Assembly Member Chiu
FEBRUARY 23, 2015
This from the Wikileaks Sony Archive:
An email from Keith Weaver, the "Executive Vice President, Worldwide Government Affairs at Sony Pictures Entertainment, provide an illustration the practical art of doing "Government Affairs," meeting "goals" for fundraisers, trying to avoid making "personal" contributions, and wondering if the donations were to much focused on another company's purchase of policy" "smells a little bit like a Disney play regarding corp. tax reform".
From: Weaver, Keith
Sent: Tuesday, August 26, 2014 5:23 PM
To: Weil, Leah
Sony referred to "WIPO treaty for blind as "stalking horse" to "denigrate the rights of copyright owners"
In the new Wikileaks archives of leaked Sony documents (Link here), there is a memo (https://wikileaks.org/sony/docs/05/docs/DECE/DECE%20CP1%20-%20ss.doc.pdf), which describes Sony Pictures Entertainment (SPE) concern over the proposed WIPO treaty for copyright exceptions for persons who are blind or have other disabilities. The memo, undated in the Wikileaks archives, but probably written in 2009, included the following passages:
The following attached letter [PDF ], from KEI and Public Citizen, asks the NIH to impose certain conditions on an exclusive license on NIH owned patents for a drug to treat the hepatitis C virus (HCV). The NIH wants to license the patents to Virotas Biopharmaceuticals, LLC, a company having a place of business in California. Other than the patents involved, the NIH requires people to sign a non-disclosure to know more about the deal.
Marrakesh in the EU: facing the excuses and delay tactics after Council statement
What the Council Statement on Marrakech says:
Council Statement: http://www.statewatch.org/news/2015/apr/eu-council-marrakesh-treaty-guidance-7321-15.pdf
Two separate issues are dealt with: how to put Marrakesh into EU law and how to ratify the Treaty
We are facing two issues put forth by EU Member States: “the appropriate sequence of the implementation of the Marrakesh Treaty” and “the appropriate legal basis for the decision, in conjunction with the question of competence (exclusive versus shared)” Even if there are first legislative changes in copyright law for Marrakesh, it is still not at all clear that EU Member States will want to ratify as exclusive EU competence.
As opposed to the Commission the Council´s position is that the Treaty cannot be implemented without changes in EU legislation. The Council presents no legal arguments for its position while the Commission has. It criticizes the Commission harshly for not presenting a legislative proposal in last year and a half and for presenting “vague proposals that lack legal certainty.” This is a blame game, a political ping-pong that wastes time and diverts attention from ratification.
Surprisingly, the Council admits that it could take the decision to ratify the Treaty now and to deposit the ratification decision in WIPO once “legal implementation” is done (but prefers to have new legislation first): “even if the Council adopts the Decision on the conclusion of the Marrakesh Treaty on behalf of the European Union, it would not be possible to deposit the relevant instruments of ratification (and thus finalise the conclusion of the Marrakesh Treaty by the European Union) until the internal EU legal framework has been adjusted accordingly.”
Competence issue: The Council admits that its own legal service agrees with the Commission that it is “EU exclusive competence” Logically this also means that the Council legal service also implies that there is no need for new legislation since the basis of EU exclusive competence is that it is already covered by EU law.
The Council says some member states want EU Treaty Article 19.1 (to combat discrimination) to also be used as a legal basis for ratification.
Finally, the Council asks the Commission to suspend the ratification request and asks to Commission to present a legislative proposal to adapt Marrakesh to EU law.
Possible Responses for the debate in the European Parliament Plenary(last week of April):
Express our profound dissatisfaction that over a year and a half time has been lost for access to culture for the visually-impaired due to a lack of consensus building, technical-legal commitment and political will on the part of EU member states. This expresses a lack of sensitivity of the needs of blind and visually impaired persons. We do not want a blame game between Council and Commission but concrete, swift progress toward Treaty ratification.
Demand that the Council presents a written position on the legislative changes it deems necessary to EU legislation so as to avoid unnecessary disagreements and delays in the future. These should be drafted in close consultation with blind persons representatives and their organizations to assure that the objectives of the Marrakesh Treaty are not weakened or changed in anyway by new EU legislation.
Reject the suspension of the Ratification process as proposed by the Council and reject inserting Marrakesh legal implementation in the general copyright debate.
Ask the European Parliament, the Commission and the Council to have three-way informal consultations to reach an agreement on the swiftest way of assuring ratification and implementation.
Demand that the Council and the Commission adopt a timetable for the ratification/implementation process.
NOTE: Please contact your MEPs. Any member of the European Parliament from any country or political group can participate in this plenary debate. Even if he/she does not have official speaking time, he or she can ask to speak briefly from the floor of the plenary debate by the “catch the eye” process.
TRIPS Council (October 2014): India calls for de-linkage and innovation inducement prizes at WTO discussions on IP & innovation
In advance of the World Trade Organization's October 2014 session of the TRIPS Council, the European Union, Switzerland and the United States made a written request to the TRIPS Council to discuss "Intellectual Property and Innovation: Promoting Awareness; Case Studies" under agenda item 12. This marked the 7th time that the United States tabled an item to the TRIPS Council relating to intellectual property or innovation.
In the context of these October 2014 discussions of Intellectual Property and Innovation, the Government of India delivered the following intervention asserting that,
Twenty groups write Congress, no fast track without public access to trade agreement negotiating texts
Twenty groups, including KEI, have written Congress, asking the Congress to provide public access to draft trade agreement texts and U.S. proposals throughout negotiations, and to specific that only agreements developed through such processes should obtain any expedited congressional consideration.
Among other things, the groups said:
On March 18, 2015, KEI, KEI Europe, and Essential Inventions submitted proposals for global voluntary licences for all patents necessary for hepatitis C (HCV) medicines to five drug companies -- AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck.
by Yannis Natsis (17/03/2015)
I recently attended a seminar in Brussels on medical innovation beautifully hosted by an important pharmaceutical company. As always, the setting was ideal. Fancy 5 star hotel, delicious buffet lunch and lots of people working in public relations. The composition of the panel followed the usual recipe successfully tried in corporate events: An esteemed member of the academia, a president of a European patient federation, a classy pharmaceutical executive, an influential certainly pro-business EU public official and an expert. Last but not least, the discussion was moderated by an excellent American facilitator.
As the presentations kicked off, the University professor emphasized the incredible economic significance of the pharmaceutical sector for jobs and growth Europe and reminded everyone that the patent system needs to be defended by all means as this is one of the very few guarantees for innovation. Innovation was underlined by the patient representative too along with repeated and rather emotional calls for patients’ timely access to new treatments in order to meet “unmet” medical needs. The pharmaceutical representative stressed that her sector invests considerable amounts of money in research and development of life-saving treatments. She added that in spite of the very high failure rates, pharma companies do not give up because “human lives are at stake”. The public official agreed and reassured her that her business’ aspirations are taken on board by EU policy-making institutions. Last but not least, the independent expert reaffirmed the need for higher patent protection and stronger enforcement of intellectual property rights as the way forward.
During the Q&A session, the high cost of medicines was briefly touched upon only to be overshadowed by voices claiming that non-treatment costs society more and that patient outcomes should be the guiding criterion in cost-effectiveness assessments. As the icing on the cake, the public official noted that the absence of streamlining of regulatory and reimbursement requirements leads to higher costs for drug development and consequently to higher end prices. The patient representative along with people from the audience reiterated the necessity to institutionalize the early dialogue between all stakeholders, increase public funding and expedite access to new treatments. “Accessibility” of medicines was another highlight of the day seen under the prism of “innovative” methods of bringing drugs to European citizens through adaptive licensing, differentiated pricing, prolonged payment of curative treatments and a more active role of patients in the authorization procedure of new medicinal products.
The meeting came to a close and I felt puzzled. “Early dialogue”, “speedy access to new treatments”, “patient outcomes”, “innovation saves lives”, “innovative payment methods”, “streamlining of regulatory requirements” were all familiar themes and at the end of the day, they make sense and do sound nice. It struck me however that new battlegrounds are appearing as pro-industry lobbies work proactively to guide future European legislation. On the EU level, there is a consistent effort to review and eventually redesign the drug development pathway from discovery to product launch and post authorization monitoring to make industry’s life easier to the detriment of public interest. To this end, the pharmaceutical industry is shaping the agenda by choosing its facts and promoting a language that is easily owned by everyone. Let’s examine some of this rhetoric but from a different perspective, that of thinking of health in terms of a public good and not merely a business.
Early dialogue of all stakeholders (regulators, payers, European Medicines Agency-EMA, Health Technology Assesment-HTA bodies): as there are multiple levels of competences and evaluation criteria split between the EU and the member states during the different phases of drug development, industry wants to guarantee that it has a decisive say in the process early on. They want a detailed overview and a reserved place around the table during the market approval phase and the very important pricing and reimbursement stage. Adaptive licensing & parallel scientific advice are two of the main EU initiatives in this direction.
Early and “speedy” access to medicines: this is the prevailing theme in the EU legislative bodies at the moment. The Council is currently reviewing the existing mechanisms of early access such as conditional approval, compassionate use, and approval under exceptional circumstances. The risks are that very expensive medicines will enter the market faster on fewer reliable clinical trial data and a higher chance of unforeseen adverse effects.
Convergence of evidence requirements: in the spirit of “early dialogues”, industry pushes for a convergence of criteria in relation to market approval, the health technology assessment and the reimbursement phase employed by the different organisations in charge of these stages. Moreover, they highlight the primacy of the European Medicines Agency (EMA) as they do not wish to face additional hurdles from national regulatory authorities. This way they can predict what is coming up and how to tailor the different evaluation stages to their capacity.
Pricing & reimbursement decisions: this is probably the most important stage as it determines patients’ access to a treatment. Market approval is (or at least should be) based on scientific criteria in order to evaluate the efficacy, quality and safety of a drug. This makes it de facto more predictable i.e. more manageable. On the contrary, pricing & reimbursement is and has always been a political decision based on a different set of criteria.
HTA bodies: these are crucial for evaluating the added therapeutic value of new medicines. Therefore, HTA bodies are increasingly regarded as gatekeepers against the flood of me-too medicines that offer modest or no real therapeutic value but usually cost a fortune to public health systems in Europe and beyond. The more HTA’s role grows as part of the regulatory framework, the more they are targeted by pharma. This is due to the HTA’s distinct and instrumental role in introducing the concept of “therapeutic added value” into the market authorization procedure. This concept signals a higher threshold for the entry of new truly innovative medicines. The EMA –whose independence and capacity to control conflicts of interest are doubtful- is currently running pilot projects on adaptive licensing and parallel scientific advice that may a) threaten HTA bodies’ independence, b) weaken the regulatory framework, and c) lower safeguards.
Cost-effective, synergies between all stakeholders: emphasis is placed on cost-effectiveness against cost-benefit analyses. Moreover, industry and the EMA’s pilot projects aim to redesign the traditional licensing path with a view to putting their products earlier on the market while relying on fewer clinical data. It is worrisome that the language used in adaptive pathways (initially named adaptive licensing) widens the scope for the entry of new medicines referring to all medicines and not only those to treat unmet medical needs.
Views on early access vary considerably among EU member states as there are economic concerns especially for those where full reimbursement of treatments is foreseen. That is why, when it comes to HTA, they favour closer cooperation but wish to keep the final assessment on the added value strictly on a national level and oppose any efforts towards a single European HTA. In the meantime, the European Commission has announced that it will conduct a study to compare how member states implement the various early-access schemes-they want to make sure that there is no market distortion, referring to off-label use. The role of patient associations in this debate cannot be overlooked. They are often encouraged by pharmaceutical companies to put pressure on governments to demand early access to treatments as is the case with the seemingly private Dutch initiative presented via mytomorrows.com which is heavily propagated in the Council by the Netherlands.
There may be no new attention-grabbing legislation coming up but all of these initiatives and pilot projects need to be closely monitored as they influence ongoing debate and most importantly future legislation. On the whole, should pharma’s strategy be successful, it will result in an ever closer incestuous cooperation between the regulator and the regulated where any independent scrutiny of new medicines and their prices could be seriously weakened.
HRC28: Statement of the European Union- Cultural Rights (Response to SR Report on Copyright and Right to Science and Culture)
On Wednesday, 11 March 2015, Oliver Hall-Allen, First Counsellor, Delegation of the European Union to the United Nations Office in Geneva delivered the following statement in response to the presentation of the Special Rapporteur in the Field of Cultural Rights (Farida Shaheed) on her Report on Copyright policy and the right to science and culture (A/HRC/28/57).
Oliver Hall-Allen (blue tie, white shirt), First Counsellor, Delegation of the European Union to the United Nations Office in Geneva
HRC28: Statement of the United States of America - Cultural Rights (Response to SR Report on Copyright and Right to Culture)
On Wednesday, 11 March 2015, Ambassador Keith Harper, U.S. Representative to the Human Rights Council, delivered the following statement to the 28th Session of the Human Rights Council on the topic of cultural rights.
HRC28: Statement by Farida Shaheed, Special Rapporteur, on Copyright policy and the right to science and culture
On Wednesday, 11 March 2015, Farida Shaheed, the United Nations Special Rapporteur in the field of cultural rights presented her seminal report on Copyright policy and the right to science and culture (A/HRC/28/57) at the 28th session of the Human Rights Council in Geneva.
Highlights from the report's recommendations include the following: