INGAPORE – Intellectual property (IP) negotiators from the 11 countries
以下、知財の議論がなされた様子
> SINGAPORE – Intellectual property (IP) negotiators from the 11 countries par
ti
> cipating in the Trans-Pacific Partnership (TPP) …
>
> ＝＝＝＝
>
> 【TPP交渉の一つの争点、医薬品（知財分野）】
> に関する米国通商専門誌における情報です。
> 9日、問題の米国知的財産権についての議論が行われた模様です。記事は行われる前
の
> 争点のまとめです。医薬品の知財を守りたい（製薬企業の利害）米国対医薬品制度を
守
> りたい他国の対立が続いています。豪州とNZは安価に市民に医薬品を供給する制度が
あ
> りまして、米国はその制度を問題にしており、特に両国市民社会では大きな反対の声
が
> 上がっています（NZでは医者や看護士の協会が反対の署名活動を行っています）
> 交渉参加国の一つ、ベトナムでは大幅に薬価が上がるのではないかという英国NGOの
オ
> ックスファムのレポートが出ましたので共有します。
> 低所得国と呼ばれるベトナムではいまだ医薬品が高く、また不足している状態で、家
計
> 消費の中で医療費の割合がとても高い状況です。ゆがんだTPP交渉の現実は、経済力
の
> 弱い国へとしわ寄せが行く現状がその実態とともにレポートされています。
> http://www.oxfam.org.nz/reports/putting-public-health-risk
> 医薬品に関しての背景情報は考えてみよう！TPPでジェネリック医薬品がピンチ？な
ど
> を参考にしてください。
> http://www.think-tpp.jp/lecture/2012_1207.html
>
>
> Inside U.S. Trade
> Daily News
> TPP Countries Poised To Revisit U.S. Access To Medicines Proposal
> Posted: March 8, 2013
>
> SINGAPORE – Intellectual property (IP) negotiators from the 11 countries par
ti
> cipating in the Trans-Pacific Partnership (TPP) talks are slated tomorrow (M
ar
> ch 9) to discuss a controversial U.S. proposal on patent protections for pha
rm
> aceuticals for the first time in roughly a year, although the United States
is
> not planning to propose any new negotiating text on this issue here, accord
in
> g to private-sector sources.
>
> At the half-day session, negotiators are expected to revisit the U.S. “acces
s
> to medicines” proposal in order to get the process moving again, as no pluri
la
> teral discussions have been held on this issue since the 11th round of talks
l
> ast March in Melbourne, sources said.
>
> One of the objectives of the session will be to allow Canada and Mexico to w
ei
> gh in on the U.S. proposal for the first time since they joined the TPP talk
s
> in October, according to these sources. U.S. trade officials have indicated
th
> ey believe the inclusion of Canada and Mexico could be helpful to the U.S. p
os
> ition, as both countries already have reasonable IP protections for pharmace
ut
> icals, according to one industry source briefed here.
>
> The U.S. proposal, originally tabled in September 2011, has faced strong opp
os
> ition from other TPP countries.
>
> Sources differed on whether they expected the U.S. to informally float any n
ew
> ideas related to its access to medicines proposal during tomorrow’s meeting
.
> The industry source said he did not believe this was likely because the admi
ni
> stration is still reflecting internally about how to proceed in this area.
>
> But another private-sector source said U.S. negotiators may informally discu
ss
> with TPP partners ways the access to medicines proposal could be changed. T
hi
> s source said U.S. negotiators have characterized this engagement with TPP p
ar
> tners as a precursor to the U.S. tabling a potential revised offer in the fu
tu
> re.
>
> In addition to obtaining input from other TPP countries, U.S. officials woul
d
> also consult with Congress and stakeholders before tabling a revised offer,
th
> is source added. He speculated that such a revised offer could be ready by t
he
> next round of talks slated for May in Peru.
>
> The notion that the Office of the U.S. Trade Representative might informally
f
> loat new ideas related to its access to medicines proposal at the Singapore
ro
> und was first raised by industry sources last month (Inside U.S. Trade, Feb.
2
> 2).
>
> Under the original U.S. access to medicines proposal, brand-name drug compan
ie
> s would be able to receive an enhanced set of protections in areas like pate
nt
> linkage, patent term extensions and data exclusivity if they sought marketi
ng
> approval in a TPP country for a given product within a certain period of ti
me
> after it had been authorized for sale in another country.
>
> The length of this so-called “access window” was not defined in the U.S. pro
po
> sal. The other missing piece of the proposal was the length of the data excl
us
> ivity period for biologic drugs. U.S. brand-name drug companies want that pe
ri
> od set at 12 years, which is the current length established in U.S. law.
>
> The industry source said most TPP countries have indicated that they will no
t
> be in a position to reply to the U.S. access to medicines proposal until the
m
> issing pieces are tabled. This source said it is unclear whether the Obama a
dm
> inistration’s internal review of the proposal will result in a revision, or
me
> rely a decision on how to fill in the missing pieces of the proposal as it n
ow
> exists.
>
> In general, this source said USTR has held bilateral consultations over the
pa
> st several months with TPP partners on the access to medicines proposal, whi
ch
> has laid the groundwork for the U.S. to move forward in this area. Those co
ns
> ultations have yielded useful information for USTR in terms of what are the
sp
> ecific problems or sensitivities certain countries have regarding the propos
al
> , as well as what sort of IP protections they already provide, this source s
ai
> d.
>
> This will help U.S. negotiators see past the “rhetorical” opposition that wa
s
> expressed by TPP countries when the access to medicines proposal was discuss
ed
> in earlier rounds, and to approach negotiations on this issue pragmatically
,
> this source argued.
>
> When it comes to Canada and Mexico, U.S. brand-name drug makers still have s
om
> e worries about their IP protections for pharmaceuticals. For instance, they
a
> re worried that Mexico has indicated it will not provide regulatory data pro
te
> ction for biologic drugs because it does not consider them to be “new chemic
al
> entities,” the industry source said.
>
> The Pharmaceutical Research and Manufacturers of America (PhRMA) has also id
en
> tified several specific issues it views as problems with Canada’s patent sys
te
> m (Inside U.S. Trade, March 1).
>
> With regard to Japan’s possible entry into the negotiations, the industry so
ur
> ce said it could be a positive development in part because it would likely d
el
> ay the talks, giving TPP negotiators more time to discuss and negotiate on p
ha
> rmaceutical provisions if the U.S. were to come out with a new proposal in m
id
> -2013.
>
> This source noted that Japan also has relatively strong IP protections for p
ha
> rmaceuticals in some areas, including eight years of data exclusivity, altho
ug
> h it does not provide any longer period for biologics. In addition, Japan ha
s
> a pharmaceutical industry that includes brand-name manufacturers who might s
ha
> re some interests with U.S. innovative pharmaceutical companies, the industr
y
> source said.
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