National legislation USA legislation Contacts for action alert

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Published on Universities Allied for Essential Medicines (http://essentialmedicine.org)
Home > National legislation
National legislation
USA [1]: generic biologics legislation and Bill S4040
Canada [2]: implementation of WTO August 30 2003 decision
Bayh-Dole Act analogues [3] in India and South Africa
USA legislation
Short Summary:
Campaigns around excessive protection of 'biologic' drug patents (2009), and global access provisions for
federally funded research (2006).
Generic biologics legislation
UAEM is working with Anthony So (Duke), UCGH, AMSA, and Essential Action to address serious
concerns with legislation being proposed in the USA on patent protection for biologic drugs, especially in
terms of the number of years of exclusivity, and the problem of evergreening.
Read more: www.AffordableMedsNow.org [4]
Bill S4040
Senator Leahy (VT) proposed the Public Research in the Public Interest Act of 2006 (S.4040) to ensure
that innovations developed at federally-funded institutions (such as universities) are made available in
certain developing countries at the lowest possible cost. The bill did not pass.
For further information:
Public Research in the Public Interest (S.4040) [5]
S4040 Backgrounder [6]
Contacts for action alert
Find the Phone Script HERE [7]
Find a Sample Email HERE [8]
Find the Main Action Alert Here [9]
Representative Contact List by State (Office Tel and Staff Names/emails Follow) **New Names
Added**
*The following names have been identified as key swing votes on the committee. You DO NOT have to be
from their district to call them. If you?d like to find your representative, go here http://www.votesmart.org/ [10]
and enter your zip code. Calling your own Representative is helpful, but most helpful today is calling the
staff of the members listed below.
*If any phone number is wrong call Capitol Switchboard at (202) 224-3121 and ask for the
Representative?s office.
* If the staff person listed is incorrect, please ask for a health staff person, Legislative Director or Chief of
Staff.
*If an email bounces, check for common errors like a wrongly spelled name, or that the formula is wrong.
Almost all house emails are as follows: [email protected] [11]
*Arizona
John Shadegg R-AZ (202) 225-3361 Health Staffer Paul Edattel [email protected] [12]
Arkansas
Mike Ross, (D-Ark) (202)225-3772 Kate Callanan [email protected] [13]
California
Jane Harman (D-CA) (202) 225-8220 Linda Shim, [email protected] [14]
Doris Matsui (D-CA) (202) 225-7163 Julie Eddy [email protected] [15]
Jerry McNerney (D-CA) (202) 225-1947, Patrick Arness [email protected] [16]
George Radanovich (R-CA) (202) 225-4540 Ted Maness [email protected] [17]
Colorado
Diana DeGette (D-CO), (202)225-4431 Heather Foster [email protected] [18]
Connecticut
Christopher Murphy (D-CT), (202) 225-4476 Paul Kidwell [email protected] [19]
Florida
Kathy Castor (D-FL) (202) 225-3376 Jocelyn Reid [email protected] [20]
Georgia
Phil Gingrey (R-GA) 202-225-2931 Robert Horne (health staff) [email protected] [21] or Josh
Waller (Legislative Director) [email protected] [22]
Illinois
Bobby Rush (D-IL), (202) 225-4372 Christopher Brown (Leg Director) [email protected]
[23]
Iowa
Bruce Braley (D-IA) (202) 225-2911 Mike Goodman [email protected] [24]
Michigan
John Dingell (D-MI) (202) 225-4071, Virgil Miller, [email protected] [25]
Bart Stupak (D-MI), (202) 225-4735 Erika Smith [email protected] [26]
*Nebraska
Lee Terry (R-NE) (202) 225-4155
Chief of Staff: Eric Hultman ([email protected] [27])
Legislative Director: Brad Schweer ([email protected] [28])
Health person: Tessie Abraham ([email protected] [29])
New York
Anthony Weiner (D-NY) (202)225-6616 Tiffany Guarascio [email protected] [30]
Elliot Engel (D-NY), (202)225-2464, Emily Gibbons [email protected] [31]
*North Carolina
Sue Wilkins Myrick (R-NC) 202-225-1976
Chief of Staff: Harold C Weatherman III (PROBABLY [email protected] [32])
Legislative Director: Jordan Moon ([email protected] [33])
Health person: Sarah Hale ([email protected] [34])
Pennsylvania
Mike Doyle (D-PA), (202)225-2135 David Lucas [email protected] [35]
Ohio
Zack Space (D-OH) (202) 225-6265 Dan Farmer [email protected] [36]
Betty Sutton (D-OH) 225-3401, Adam Goldstein [email protected] [37] or Christine Corcoran
[email protected] [38]
Tennessee
Bart Gordon (D-,TN) (202) 225-4231 Dana Lichtenberg [email protected] [39]
*Texas
Michael Burgess (R-TX) 202-225-7772
Chief of Staff: Barry Brown [email protected] [40],
Health person/Legislative director: James Paluskeiwicz (Paloosh-ka-witz)
U.S. Virgin Islands
Donna Christensen (D-USVI) (202) 225-1790 Britt Weinstock [email protected] [42]
Vermont
Peter Welch (D-VT), (202) 225-4115, Bob Rogan [email protected] [43], Stephanie Kenrich
Virginia
Rick Boucher (D-VA), 225-3861 Laura Vaught [email protected] [45]
Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) are seeking to add their 14.5 year biogenerics
proposal to the House health care reform bill by amendment as early as tomorrow. They have strong
support but there are enough representatives on the fence that we can turn the situation around and have
the amendment defeated so that a better proposal can be adopted.
We need your help to change this. Will you call and/or email the key swing representatives on the
Energy & Commerce Committee today and ask them to vote NO on the Eshoo-Barton biologics
proposal? Tell them that 14.5 years data exclusivity for biologics is too much and that nothing
more than a seven (7) year compromise should be accepted.
Action phone script
Contact Information for Key Representatives to Contact HERE [46]
Find a Sample Email HERE [8]
Phone Script: (What to say whether you reach a staff person or are sent to voicemail)
1. Identify yourself and then tell him or her you would like to leave a brief message for the Representative,
such as: ?Please tell Representative xxx I would like them to vote against the Eshoo-Barton biogenerics
proposal ? which features 14.5 years of data exclusivity ? being added to the health care reform bill. Also,
please tell him or her that I would like them to support the generic biotech drug proposal which offers the
lowest amount of data exclusivity possible, such as the Obama Administration?s generous compromise of
a seven (7) year base period. I would prefer to see a low data exclusivity period so that consumers get
affordable generic cancer and arthritis drugs as early as possible.
2. You may also want to briefly state reasons for your support. It is best that you all state your reasons in
your own words. If you all say exactly the same thing, it is not as powerful.
One idea is to say something like ?I am against the Eshoo-Barton 14.5 year proposal and I support giving
much less data exclusivity to brand-name biologic drugs because data exclusivity can delay the
introduction of price-lowering generic drug competition. Please make sure consumers don?t wait far too
long for affordable versions of life-saving cancer and arthritis drugs.?
OR
?Biologics cost much more than conventional drugs but the brand-name industry?s own studies show they
cost the same to develop. Please make sure consumers don?t pay too heavy a price and wait far too long
for life-saving cancer and arthritis drugs.?
3.Remember to thank them.
4. If you get his or her voicemail, leave your name and phone number so he or she can respond to you,
and let them know that you will follow-up.
5. Please keep track of any positive or negative responses, and report back to Ethan Guillen of UAEM
Whether or not you reach the person, you may also want to send a follow-up email, using the
sample email below, to make sure they get your message in time. Phone conversations are more
effective than emails, but emails are checked more frequently than voicemail.
Sample email
Contact Information for Key Representatives to Contact HERE [46]
Find the Phone Script HERE [7]
Sample Biogenerics Email to House Staff
Re: The Vote on Generic Biotech Drugs in the Health Care Reform Bill
Dear [insert name],
I am writing to ask Representative [insert name] vote against the Eshoo-Barton generic biologics proposal
? which features 14.5 years of data exclusivity ? when the Energy and Commerce Committee considers
adding it to the health care reform bill in the coming days. I would like him or her to support a proposal with
a much lower period of data protection, such as the Obama Administration?s ?generous compromise? of
seven (7) years of data exclusivity. I would prefer to see as little data exclusivity as possible so that
consumers get affordable generic biologic drugs at the earliest possible date.
Biologics are very expensive medicines which include cancer treatments, vaccines and a variety of other
interventions, many of which costs tens of thousands of dollars per patient, per year. Current prices
threaten to further cripple our health care system.
As you know, traditional chemical drugs received a minimum of five (5) years of data exclusivity under the
1984 Hatch-Waxman Act. I believe the same amount should be given to biologics. The brand-name
industry is seeking fourteen years of protection for biologics. The Federal Trade Commission recently
found that a 14 year-period would be excessive and unnecessary to induce further biomedical innovation.
[i] However, I will support the generous compromise of seven (7) years if that is put forward in your
committee.
At a time when we are seeing the cost of our health care growing out of control, when 60% of bankruptcies
are related to health care costs, [ii] please demonstrate your commitment to American consumers by
ensuring lower-cost generic medicines to consumers while continuing to provide incentives for innovation.
Thank you for your consideration. I?ll look forward to your response and am happy to speak further about
this issue with you or a member of your staff.
Kind Regards,
NAME, AFFILIATION (eg. Universities Allied for Essential Medicines or American Medical Student
Association and your University)
ADDRESS (VERY IMPORTANT TO INCLUDE YOUR ADDRESS IF YOU HAVE AN ADDRESS IN THE
SENATOR?S HOME STATE )
Notes
i See Federal Trade Commission, Emerging Health Care Issues: Follow-On Biologic Drug Competition,
June 2009. Available at: http://www.ftc.gov/opa/2009/06/biologics.shtm [48] and Henry Grabowski, Outlook:
Follow-on biologics: data exclusivity and the balance between innovation and competition. Nature Reviews
Drug Discovery 7, 479-488 (June 2008). Available at:
http://www.nature.com/nrd/journal/v7/n6/full/nrd2532.html [49].
ii Arnst, Catherine. ?Study Links Medical Cost and Personal Bankruptcy.? BusinessWeek June 4, 2009.
Available at: http://www.businessweek.com/bwdaily/dnflash/content/jun2009/db2009064_666715.htm [50]
Canadian legislation
Short Summary:
UAEM is supporting the efforts by the Canadian HIV/AIDS Legal Network to reform Canada's Access to
Medicines Regime (CAMR), patent legislation intended to allow generic Canadian production of patented
medications for export to poor countries, but underused due to excessive red tape.
Help Us Fix Canada?s Access to Medicines Regime (CAMR)
URGENT ACTION NEEDED:
HELP US TO TAKE ACTION IN OCTOBER - Please act ASAP, ideally before October 23rd.
EMAIL FEDERAL PARTY LEADERS, THE PRIME MINISTER, AND LOCAL MPs
TO SUPPORT THE PASSAGE OF BILL C-393 IN THE HOUSE OF COMMONS
WHY NOW?
NOW is a critical moment in our campaign to persuade our government to fix CAMR legislation. With
CAMR fixed, Canada can keep its promise to provide a steady flow of lower-cost, live-saving medicines to
Africa. Bill C-393 is our best hope for fixing CAMR.
On Friday, October 23rd, Bill C-393 will be debated at a 2nd-hour reading in the House of Commons. It is
important that enough MPs pass the Bill on to a committee that can review the proposed reforms and hear
from experts on this important issue. This vote is set to take place on Wednesday, October 28th. The NDP
is supportive of Bill C-393. The Conservative Party has consistently maintained its position that it opposes
the proposed reforms; so, we can anticipate that they will vote ?NO? on passing the Bill after 2nd reading.
A ?YES? majority depends on convincing Liberal and Bloc MPs to support Bill C-393.
It is very important that we contact all Party Leaders, local MPs, and the Prime Minister, and urge them to
support Bill C-393 and allow it to be reviewed by a committee.
WE NEED YOU.
The more people who take action at this time, and email Canada?s Federal Party Leaders and their local
MPs, the better! We want to create a huge impact by flooding inboxes with requests for support of Bill C393.
WHAT CAN YOU DO?
There are 2 Actions we are asking you to take:
1. PLEASE email (or phone) your message of support to Federal Party Leaders, including the Prime
Minister here: http://org2.democracyinaction.org/o/6158/t/7421/campaign.jsp?campaign_KEY=2173 [51].
Cette lettre est disponsible en français ici:
http://org2.democracyinaction.org/o/6158/t/7421/campaign.jsp?campaign_KEY=2177 [52]
2. Email your local MP with the template email below. To find your local MP, go to:
http://www2.parl.gc.ca/Parlinfo/Compilations/HouseOfCommons/MemberByPostalCode.aspx?Menu=HOC
[53].
Enter your postal code to find the contact info for your local MP and then send them an email modeled on
the one noted below.
Do this today!
BACKGROUND RESOURCES
1. Please visit www.aidslaw.ca/camr [54] for more information on CAMR reform. You can view our short
video entitled, ?Dying for Drugs? which features the Canadian HIV/AIDS Legal Network?s Executive
Director, Richard Elliott, and UNICEF President, Nigel Fisher, speaking on the need for access to low-cost
medicine in the developing world.
2. A CAMR 20 Questions & Answers document can be found at
http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=965 [55]. This is a great information resource
and we encourage you to distribute this amongst your members, and to other concerned student groups on
your campus. It addresses many of the opposition arguments to the proposed reforms in Bill C-393 in the
House of Commons.
3. Contact Lindsey [56] if you are looking for additional resources, and/or have specific questions.
Information regarding each local MPs? positions on Bill C-393 is available, so please ask!
Thank you for your support on this important campaign!
Sample Email for your local MP
Cette lettre est disponsible en français ci-dessous
English
(Date)
Dear Mr/Ms (surname), Member of Parliament, (local riding),
On September 16th a shipment of drugs left the Toronto airport bound for Rwanda. It has taken years of
persistence and determination for Apotex to send this second part of a shipment of drugs to dying Africans.
In 2004, Canada responded to the urgent need for low-cost, life saving medicines by passing Canada?s
Access to Medicines Regime (CAMR) with all party support. Unfortunately, CAMR is too flawed to be
effective. The delivery of one order to one country by one generic drug company in five years cannot be
termed successful. We Canadians have a responsibility to do better. And we can.
Bill C-393, which is designed to simplify the process with a one-license proposal, offers a solution in
streamlining CAMR. Knowledgeable experts have answered every question raised about the amendment.
There is no cost and it adheres to WTO, TRIPS and health regulations.
This is a humanitarian rather than a trade issue. The picture of children dying of AIDS before their second
birthday is heart wrenching. We cannot bear this reality, knowing that Canada could provide the medicines
necessary to keep these children and their parents alive.
Apotex Canada has indicated its willingness to develop a medicine primarily for children, one dose, easy to
swallow. But their commitment is based on making CAMR more workable.
I ask that you acknowledge that in principle there is a problem with the current CAMR by supporting Bill C393 at its 2nd reading. It is only fair that ideas about reforming it should not simply be dismissed outright.
Instead, the details of the reforms should be considered by a committee that can hear from experts. You
have the information regarding CAMR that you need; you have the potential to pass this bill. I urge you to
hear the plea of Canadians joining the voices of those in developing nations who are holding their dying
children. Please help. Support Bill C-393.
I look forward to your response to this letter and your indication that you will support this bill.
Sincerely,
(Name)
(Address)
(Telephone and email address)
Français
(Date)
Cher/Chère M./Mme. (nom), Membre du Parlement, (circonscription électorale),
Le 16 septembre, une cargaison de médicaments a quitté l?aéroport de Toronto en destination du
Rwanda. Apotex a investi des années de travail acharné pour envoyer cette deuxième partie d?une
livraison de médicaments à des Africains mourants.
En 2004, le Canada a répondu au besoin urgent de médicaments à faible coût et d?importance vitale en
adoptant le Régime canadien d?accès aux médicaments (RCAM), avec le soutien de tous les partis.
Malheureusement, le RCAM est trop défectueux pour être efficace. On ne peut qualifier de réussite un
programme qui a mené à la livraison, en une période de cinq ans, d?une seule commande à un seul pays
par une seule compagnie de médicaments génériques. Le Canada a la responsabilité de mieux faire. Et
nous en sommes capables.
Le projet de loi C 393 est conçu pour simplifier le processus du RCAM au moyen d?une solution à licence
unique. Des spécialistes ont répondu à toutes les questions soulevées par cette rectification. La réforme
ne coûte rien et est conforme aux lois de l?Organisation mondiale du commerce et de l?Accord sur les
ADPIC et au règlement en matière de santé.
Il s?agit là d?une question humanitaire et non commerciale. L?idée d?enfants qui meurent du sida avant
leur deuxième anniversaire crève le c?ur. Nous ne pouvons permettre cela en sachant que le Canada a
les moyens de fournir les médicaments nécessaires pour garder ces enfants et leurs parents en vie.
Apotex Canada a exprimé le souhait de produire un médicament à dose unique et facile à avaler à l?intention
des enfants principalement. Mais elle ne conservera son engagement que si le RCAM est rendu plus
utilisable.
Les idées liées à la réforme du RCAM méritent mieux que d?être simplement écartées. Au contraire, les
détails des changements proposés devraient être examinés par un comité dont le travail sera éclairé
par des spécialistes. Je vous demande de reconnaître en principe que le RCAM sous sa forme actuelle est
inefficace. Demandez aux membres de votre parti d?appuyer le projet de loi C 393 afin de lui permettre
d?être soumis à un comité qui l?étudiera minutieusement.
Vous avez tous les renseignements sur le RCAM dont vous avez besoin. En tant que chef de votre parti,
vous avez la capacité de mener vos membres dans la bonne direction. Je vous encourage vivement à
entendre l?appel des Canadiens et Canadiennes qui joignent leurs voix à celles des personnes dans les
pays en développement qui tiennent leurs enfants mourants dans leurs bras. Je vous demande d?aider.
Appuyez le projet de loi C 393.
J?attends avec enthousiasme votre réponse à cette lettre et votre marque de soutien ? la vôtre et celle de
votre parti ? envers ce projet de loi.
Je vous prie d?agréer, Messieurs, l?expression de mes meilleurs sentiments.
(Nom)
(Adresse)
(Téléphone adresse courriel)
Bayh-Dole Act analogues
Short Summary:
The Bayh-Dole Act (USA, 1980) governs the patenting and licensing of publicly funded research in the
USA. It has a mixed record despite strong positive rhetoric. Similar Acts are now being developed in both
India and South Africa. UAEM has analyzed the development of these new Acts.
The Bayh-Dole Act (USA, 1980) governs the patenting and licensing of publicly funded research in the
USA. It has a mixed record despite strong positive rhetoric. The Act is now being copied in various ways in
different countries. UAEM has analyzed various country efforts. On this page you can access various
UAEM analysis as well as additional reading resources on the patenting of publicly-funded research.
INDIA
The Indian government is currently considering troubling legislation modeled on the USA Bayh-Dole Act of
1980. You can read our press release on the legislation [57], and below find a white paper outlining issues
with the US Bayh-Dole Act and the Indian draft legislation.
Download the most recent UAEM white paper on the Indian Bayh-Dole legislation here (April 22, 2010). [58]
Download UAEM's comments to the Ministry of Science and Technology on the Indian Bayh-Dole
legislation here. [59]
Download the UAEM white paper on the Indian Bayh-Dole legislation here [60].
Download the most recent draft version of the Indian Bayh-Dole legislation [61].
Download an older draft version of the Indian Bayh-Dole legislation [62].
Download a comparison of the two versions [63].
SOUTH AFRICA
South Africa adopted the ?Intellectual Property Rights from Publicly Financed Research and Development
Act? in 2008. The Act went into effect in August 2010 along with the final regulations for this Bayh-Dole
Analogue.
Download the final regulations [64]
Download UAEM's proposed amendments and revisions to the regulations
[65]
UAEM performed a brief analysis on the regulations which you can read in our letter to the South African
government [66].
Download the Intellectual Property Rights from Publicly Financed Research and Development Act [67].
Download the draft regulations [68].
Other Reading on the Bayh-Dole Act
Anthony So et al. Is Bayh-Dole Good for Developing Countries? Lessons from the US Experience [69], 6
PLoS Biol., e262.
David C. Mowery & Bhaven Sampat. ?The Bayh-Dole Act of 1980 and University-Industry Technology
Transfer: A Model for Other OECD Governments? [70]? The Journal of Technology Transfer, Volume 30,
Numbers 1-2, January 2005 , pp. 115-127(13)
Jeannette Colyvas et al., ?How Do University Inventions Get Into Practice? [71]? Management Science, Vol.
48, No. 1, January 2002, pp. 61-72, DOI: 10.1287/mnsc.48.1.61.14272
David C. Mowery et al. 1999. The effects of the Bayh-Dole Act on U.S. university research and technology
transfer. Industrializing Knowledge.Lewis Branscomb, ed. MIT Press, Cambridge, MA.
Peter Arno & Michael Davis, ?Why Don?t We Enforce Existing Drug Price Controls? The Unrecognized
and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part
from Federally Funded Research [72],? 75 Tulane Law Review 631 (2001).
Copyright 2010 Universities Allied for Essential Medicines. This work is licensed under a Creative
Commons BY-NC-SA 2.5 License. Site design and maintenance by Matt Reimer.
Source URL: http://sandbox.essentialmedicine.org/projects/legislation
Links:
[1] http://essentialmedicine.org/projects/legislation/usa
[2] http://essentialmedicine.org/projects/legislation/canada
[3] http://essentialmedicine.org/projects/legislation/bayh-dole
[4] http://www.affordablemedsnow.org/
[5] http://essentialmedicine.org/archive/bill-S4040
[6] http://essentialmedicine.org/archive/bill-s4040-backgrounder
[7] http://essentialmedicine.org/projects/legislation/usa/phone
[8] http://essentialmedicine.org/projects/legislation/usa/email
[9] http://essentialmedicine.org/story/2009/08/31/urgent-vote-house-friday-help-control-drug-costs-contacting-yourrepresentative-tod
[10] http://www.votesmart.org/
[11] mailto:[email protected]
[46] http://essentialmedicine.org/projects/legislation/usa/action-contact
[48] http://www.ftc.gov/opa/2009/06/biologics.shtm
[49] http://www.nature.com/nrd/journal/v7/n6/full/nrd2532.html
[50] http://www.businessweek.com/bwdaily/dnflash/content/jun2009/db2009064_666715.htm
[51] http://org2.democracyinaction.org/o/6158/t/7421/campaign.jsp?campaign_KEY=2173
[52] http://org2.democracyinaction.org/o/6158/t/7421/campaign.jsp?campaign_KEY=2177
[53] http://www2.parl.gc.ca/Parlinfo/Compilations/HouseOfCommons/MemberByPostalCode.aspx?Menu=HOC
[54] http://www.aidslaw.ca/camr
[55] http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=965
[57] http://essentialmedicine.org/story/2008/11/17/uaem-calls-indian-government-reconsider-legislation-regardingpatenting-publicly-fu
[58] http://essentialmedicine.org/archive/uaem-white-paper-indian-bayh-dole-bill-revised-april-22-2010
[59] http://essentialmedicine.org/archive/uaem-comments-indias-ministry-science-proposed-revisions-indian-bayh-dolebill
[60] http://essentialmedicine.org/archive/uaem-white-paper-indian-bayh-dole-act
[61] http://essentialmedicine.org/archive/indian-bayh-dole-act-draft-version
[62] http://essentialmedicine.org/archive/indian-bayh-dole-act-first-draft
[63] http://essentialmedicine.org/archive/comparison-two-drafts-indian-bayh-dole-act
[64] http://essentialmedicine.org/archive/final-south-african-bayh-dole-regulations
[65] http://essentialmedicine.org/archive/uaems-suggested-revisions-south-africas-draft-regulations-august-11-2009
[66] http://essentialmedicine.org/archive/uaem-comments-south-african-bayh-dole-act-proposal
[67] http://essentialmedicine.org/archive/south-africa-ip-act
[68] http://essentialmedicine.org/archive/draft-regulations-south-africas-2008-ipr-act
[69] http://biology.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pbio.0060262
[70] http://openurl.ingenta.com/content?genre=article&issn=0892-9912&volume=30&issue=12&spage=115&epage=127
[71] http://mansci.journal.informs.org/cgi/content/abstract/48/1/61
[72] http://ssrn.com/abstract=243040

National legislation USA legislation Contacts for action alert

Transcription

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