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2.

1 Issue : Medicine
2.1.1 Cause : Stated in Following Chapter
2.1.1.1 Public-Citizen-Statement-on-WikiLeaks-TPP-Publication
Subject: Trade deal leaked, would endanger public health For Immediate
WikiLeaks Publication of Complete, Final TPP Intellectual Property Text Confirms
Pact Would Raise Costs, Put Medicines Out of Reach
Final Deal Rolls Back Bush-Era May 2007 Access to Medicine Protections
WASHINGTON, D.C. WikiLeaks publication today of the final Trans-Pacific
Partnership (TPP) Intellectual Property chapter text verifies that the pact would harm
public health by blocking patient access to lifesaving medicines, Public Citizen said
today. The latest leak of a secret TPP text reveals how the TPP would roll back the May
10 Agreement reforms brokered in 2007 between Democratic congressional leaders and
the George W. Bush administration. It also reveals the contentious death sentence
clause on biologics, or biotech drugs, which roiled TPP talks in Maui and Atlanta. If the
TPP is ratified, people in Pacific Rim countries would have to live by the rules in this
leaked text, said Peter Maybarduk, director of Public Citizens Global Access to
Medicines program. The new monopoly rights for big pharmaceutical firms would
compromise access in TPP countries. The TPP would cost lives. The leak comes the
morning after a White House meeting with pharmaceutical executives who are
dissatisfied that the deal did not provide them even greater monopoly rights. The
monopolist pharmaceutical industry has won a lot with the TPP, at the expense of
peoples health, said Burcu Kilic, policy director for Public Citizens Global Access to
Medicines program. They should stop crying crocodile tears. WikiLeaks published the
complete TPP Intellectual Property Chapter, dated Monday, October 5, 2015 the date
that the 12 Pacific Rim nations announced a final TPP deal. The leaked text does not
contain negotiating country brackets, indicating rules are no longer subject to debate, but
rather are the final version subject only to a legal scrub. Read the full release. ###
These final TPP rules would lengthen, strengthen and broaden special patent and data
protections, which pharmaceutical companies use to delay generic competition and keep
drug prices high, said Maybarduk. The text shows that TPP rules do not even conform to

the Bush-era May 10 access to medicines standards that many congressional Democrats
had insisted be further improved. In contravention of the May 10 standard, TPP imposes
patent term extensions and additional and longer marketing exclusivities, as shown in
Public Citizens analysis (PDF). Unlike the May 10 Agreement standard, the TPP would
require developing countries to quickly transition to the same rules that apply to
developed countries, which provide extreme monopoly rights for the pharmaceutical
industry and limit access to affordable medicines. From very early on in the TPP
negotiations, and to the ire of health advocates, it became apparent that the Office of the
U.S. Trade Representative (USTR) was abandoning the May 10 Agreement template,
said Maybarduk. With todays publication of the final version of the TPP IP chapter by
WikiLeaks, for the first time the public can see precisely which rules negotiators agreed
to and, importantly, how far beyond the May 10 Agreement the provisions extend
pharmaceutical intellectual property obligations in developing countries. Pharmaceutical
intellectual property and access to medicines have been especially contentious issues in
the TPP talks, contributing to years of delay in the Obama administrations timeline for
completing a TPP deal. While various new monopoly rights for drug firms were agreed to
by participating nations, confrontations over a special exclusivity rule for biologics
medical products derived from living organisms, including many new and forthcoming
cancer treatments contributed to the meltdown of the August ministerial in Hawaii and
the double-overtime nearfailure in Atlanta. Biologics exclusivity is separate from and
independent of patent protection, though the protections may overlap. The USTR initially
supported a twelve- and then an eight-year minimum monopoly period, while a majority
bloc of negotiating countries would not consider more than five years exclusivity. (Five
countries provide no special biologics exclusivity rule at all in their laws.) A Public
Citizen analysis of the biologics provisions is available here (PDF). The final document
imposes a minimum mandatory five-year period. It also subjects the issue to future
discussions of a TPP Commission and efforts to deliver a comparable effective
period. This reflects a USTR effort to impose eight-year monopolies over countries
refusal. That purposefully ambiguous language is meant to provide USTR a means to
harass countries in the future, and keep pushing for longer monopolies and industry
profits at the expense of peoples health, said Kilic. The USTR has indicated its solution

to medicine access would include transition periods for developing countries. Yet the
leaked text shows that transition periods would last only three to ten years and apply to
only a few of the rules under discussion. A Public Citizen analysis of the transition
periods in the leaked text is available here (PDF). Forcing expansive pharmaceutical
monopoly rules on countries that can scarcely afford high drug prices has not always
been U.S. trade policy, and in the past U.S. policymakers have recognized that the needs
of developing countries should not always be subordinate to U.S. pharmaceutical industry
profits, said Maybarduk. Some rare public servants from TPP countries fought back
and stood for health in this negotiation. Their efforts saved lives, said Maybarduk. Yet
in the end, the TPP will still trade away our health
2.1.1.2 Pharmaceutical Provisions in the TPP
Patent Linkage (Article QQ.E.17)
Patent linkage is a regulatory mechanism that links medicine marketing approval
to patent status. Under some forms of linkage, even spurious patents may function as
barriers to generic medicine registration. Patent linkage can facilitate abuse, since the
financial benefits to patent holders of deterring generic market entry may outweigh risks
of penalties. Earlier TPP drafts included a U.S. proposal that would have required
countries to automatically block generic market entry in case of alleged patent
infringement. The text is more permissive now, and provides countries with options:
1. If a Party permits, as a condition of approving the marketing of a pharmaceutical
product, persons, other than the person originally submitting the safety and efficacy
information, to rely on evidence or information concerning the safety and efficacy of a
product that was previously approved, such as evidence of prior marketing approval by
the Party or in another territory, that Party shall provide:
(a) a system to provide notice to a patent holder or to allow for a patent holder to be
notified prior to the marketing of such a pharmaceutical product, that such other
person is seeking to market that product during the term of an applicable patent
claiming the approved product or its approved method of use;
(b) adequate time and opportunity for such a patent holder to seek, prior to the
marketing of an allegedly infringing product, available remedies in subparagraph

(c)
(c) procedures, such as judicial or administrative proceedings, and expeditious
remedies, such as preliminary injunctions or equivalent effective provisional
measures, for the timely resolution of disputes concerning the validity or
infringement of an applicable patent claiming an approved pharmaceutical product.
or its approved method of use.
Patent Term Adjustment (Article QQ.E.14)
Patent term adjustments (typically called extensions) significantly delay market
entry of generic medicines and restrict access to affordable medicines.
1. Each Party shall make best efforts to process applications for marketing approval of
pharmaceutical products in an efficient and timely manner, with a view to avoiding
unreasonable or unnecessary delays.
2. With respect to a pharmaceutical product that is subject to a patent, each Party shall
make available an adjustment of the patent term to compensate the patent owner for
unreasonable curtailment of the effective patent term as a result of the marketing
approval process.
3. For greater certainty, in implementing the obligations of this Article, each Party may
provide for conditions and limitations provided that the Party continues to give effect
to this Article.
4. With the objective of avoiding unreasonable curtailment of the effective patent term, a
Party may adopt or maintain procedures that expedite the examination of marketing
approval applications.
The first paragraph of this text follows the wording of the previously leaked texts
(October 2014 and May 2015) and encourages countries to process patent applications
and applications for marketing approval of pharmaceutical products in an efficient and
timely manner.
The relevant provision in the November 2013 WikiLeaks text provided patent term
adjustments not only for patents covering new pharmaceutical products but also for
patents that cover methods of making or using pharmaceutical products. The scope of this
provision is now narrower than it was. And it is also narrower than the relevant provision
in the Korea-U.S. Free Trade agreement.

The earlier version of the provision provided limitations on the period and
applicability of patent term extensions. These limitations were similar to, though not
entirely the same as; those found in the U.S. Patent Act, i.e., a party may limit extensions
to one per pharmaceutical product. The current version of the text does not prescribe
limitations, but rather allows Parties to provide for conditions and limitations within their
own legal system and practice and encourages Parties to adopt or maintain procedures
that expedite the examination of marketing approval applications.
Regulatory Review Exception (Article QQ.E.15)
Without prejudice to the scope of, and consistent with, QQ.E.4, each Party shall
adopt or maintain a regulatory review exception (53) for pharmaceutical products.
FN53: For greater certainty, consistent with QQ.E.4, nothing prevents a Party from
providing that regulatory review exceptions apply for purposes of regulatory reviews in
that Party, in another country, or both.
The regulatory review exception, widely known as the Bolar exception in the
United States, helps speed generic medicines to market. It is a safe harbor provision that
permits the generics manufacturer to make small batches to apply for marketing approval
before the patent expires without risk of liability for infringement. QQ.E.4. mimics the
language of Article 30 of TRIPS and permits Parties to adopt a regulatory review
exception: Members may provide limited exceptions to the exclusive rights conferredby
a patent, provided that such exceptions do not unreasonably conflict with a normal
exploitation of the patent and do not unreasonably prejudice the legitimate interests of the
patent owner, taking account of the legitimate interests of third parties. The earliest
version of this provision limited the application of the provision to testing conducted with
the intent of seeking domestic regulatory review only. The final provision adopts a
generalized and flexible approach. It reflects Canada and New Zealands existing
regime with respect to the early regulatory review exception and applies to products
submitted for domestic regulatory review as well as products submitted for regulatory
review in foreign jurisdictions.
Pharmaceutical Data Protection/Protection of Undisclosed Test or Other Data
(Market exclusivity) (Article QQ.E.16)

If a Party requires, as a condition for granting marketing approval for a new


pharmaceutical product, the submission of undisclosed test or other data concerning the
safety and efficacy of the product (54) , the Party shall not permit third persons, without
the consent of the person who previously submitted such information, to market the same
or a similar(55) product on the basis of:
(i) that information; or
(ii) the marketing approval granted to the person who submitted such information for at
least five years(56) from the date of marketing approval of the new pharmaceutical
product in the territory of the Party .
FN 54: Each Party confirms that the obligations of Article QQ.E.16, and QQ.E.20 apply
to cases in which the Party requires the submission of undisclosed test or other data
concerning:
(a) only the safety of the product,(b) only the efficacy of the product, or (c) both.
FN 55: For greater certainty, for purposes of this Section, a pharmaceutical product is
similar to a previously approved pharmaceutical product if the marketing approval, or,
in the alternative, the applicants request for such approval, of that similar pharmaceutical
product is based upon the undisclosed test or other data concerning the safety and
efficacy of the previously approved pharmaceutical product, or the prior approval of that
previously approved product.
FN 56: For greater certainty, a Party may limit the period of protection under Article
QQ.E.16.1 to 5 years, and the period of protection under Article QQ.E.20.1 (a) to 8 years.
Exclusivity rules delay generic drug registration for a specified period of time, by
limiting the ability of generics manufacturers and regulatory authorities to make use of an
originator companies data and grant generics marketing approval. The provision mirrors
the language in the Australia-U.S. Free Trade Agreement (AUSFTA) and it allows for at
least five years5 of market exclusivity for new pharmaceutical products. The Parties
shall not permit third parties to market the same or similar product using the same test or
other data concerning the safety and efficacy of the product. It is important to mention
that market exclusivity means that Parties can accept generic medicine applications
during those five years, but cannot grant the marketing approval before 5 years pass from
the date of marketing approval in the territory of the Party. The footnote 57, clarifies that

'at least' doesn't mean have to do more than 5 or 8 years.The provision distinguishes
between the information required and permitted. If a Party relies on required undisclosed
test or other data to grant a marketing approval, paragraph (a) applies. If a Party relies on
the marketing approval conferred in a foreign country paragraph (b) applies. The
WikiLeaks text of November 20136 conferred exclusivity for any information submitted
in support of marketing approval, even if it is disclosed and in the public domain. The
scope of exclusivity is more limited now, provided only for undisclosed test or other
data.
Products that are considered to be the same as or similar to the reference product
are also excluded from relying on its protected data. Footnote 56 clarifies that a
pharmaceutical product can be a similar to a previously approved pharmaceutical
product if the marketing approval of that similar pharmaceutical product is based upon
the information concerning the safety or efficacy of the previously approved
pharmaceutical product, or the prior approval of the
reference product.
Perus Annex incorporates the concurrent period concept from the U.S.-Peru FTA.
Peru has the option of starting the exclusivity clock from the date of U.S. marketing
approval (or first approval in another TPP Party), rather than from the date of marketing
approval in Peru. This applies, however, only so long as Peru approves a product within 6
months of the date an application is filed with the Peruvian authorities. In practical terms,
this can shorten the exclusivity period in Peru, if the originator takes a long time to apply
for marketing approval in
Peru.
Malaysias Annex permits Malaysia to keep its so called access window system.
A pharmaceutical company must file a marketing approval request in Malaysia within 18
months after the product is first registered in any country, or forfeit market exclusivity.
The access window is for new pharmaceutical products, new clinical
information/combinations and biologics. However the periods of protection start from the
date of first marketing approval in Malaysia. Bruneis Annex includes the same access
window as Malaysia with the same conditions.
2.1.1.3 October 9, 2015 TPP Transition Periods on Pharmaceutical Intellectual Property

Rules
Bad Rules Coming Soon in a TPP Country Near You
Forcing expansive pharmaceutical monopoly rules on countries that can scarcely
afford high medicine prices has not always been U.S. trade policy, and in the past U.S.
policymakers have recognized that the needs of developing countries should not always
be subordinate to U.S. pharmaceutical industry profits.
It is vitally important to remember that, with limited exceptions articulated in the
endnotes below, all TPP countries regardless of level of development, poverty or wealth
will be required to adopt the TPPs pharmaceutical IP rules. The periods are too short to
expect that countries will be substantially more able to absorb the rules impact than they
are today. There is little reason to believe that these rules would actually be good for the
people residing in TPP countries, even after the transition periods allowed. Indeed, even
in the U.S., where similar rules are already in place, the high prices of medicines
bolstered by TPP-style monopolistic protections have led to treatment rationing,
prescriptions going unfilled and severe budgetary strains
2.1.1.4 Bad Rules Coming Soon in a TPP Country Near You
October 9, 2015 WikiLeaks Publishes Final TPP Intellectual Property Text
Analysis1: Ambiguity Leads to Fallacy: Biologics Exclusivity in the Trans-Pacific
Partnership
Leak2 Shows TPP Would Impose New Monopoly Requirements, Limiting
Access to New Cancer and Other Biotech Medicines
Relationship to Patents: Biologics may not be patentable in all cases, as they are
naturally occurring products such as insulin or components of human blood. This leaked
text requires TPP countries to stop generic versions of biologic medicines (biosimilars)
from being available to patients, even when there is no patent or beyond the term of a
patent.
WikiLeaks-TPP-Transparency-Healthcare-Annex
Trans-Pacific Partnership Agreement
Transparency Chapter Annex on Transparency and Procedural Fairness for
Pharmaceutical Products and Medical Devices

WikiLeaks release: June 10, 2015


This is the secret December 2014 draft (with country negotiating positions) of an
annex to the Trans Pacific Partnership Agreement (TPP) "Transparency Chapter". The
TPP is an attempt to create a transnational treaty regime encompassing 40 per cent of
global GDP and one-third of world trade. The draft Annex places requirements and
restrictions on national healthcare access programs in how they allocate public subsidies
for medicines and medical devices.
The second option is similar to the U.S. hard linkage system which prevents
generics companies from getting marketing approval during the patent term unless by
consent or acquiescence of the patent holder. A Party would create an extra-judicial
system to prevent the applicant from marketing a product, or a product for an approved
use, which are claimed under a patent. This system requires direct coordination between
the marketing approval authority and the patent office. The obligation extends to cover
the entire term of the patent, unless the patent owner has consented to, or acquiesced in,
the use of the information. Footnote 60 clarifies that a Party could provide protection
going beyond the obligations herein and apply this provision to any pharmaceutical
product that is subject to a patent. Although there were discussion and even a proposed
measure to exclude biologics from patent linkage, no such exclusion appears obvious
from the text.
2.1.2 Effects : Price of medicines will increase dramatically (cons)
By signing the TPPA, Malaysia will automatically comply with the agreement to
only buy drugs from the original company. Some parties stressed that Malaysians could
face price increases of 60% -80% for certain drugs, while other authorities insist that
patented drugs can be 1,044% more expensive than common generic drugs. This is
because of cheaper generic drugs can not be sold again as Malaysia bonded using
patented medicines (genuine) produced pharmaceutical companies from overseas.
The agreement which involves the regulation of generic drugs are not allowed to
sold fake medicines such as Panadol, which is cheaper than have content and effect
similar to the original drug. This means that the drug can only be purchased directly from

original pharmaceutical company that will cause the cost of drugs is very expensive. This
happens because the TPP agreement on Intellectual Property Rights enforceable to
protect the international pharmaceutical. Although these drugs are derived from the
original companies in the US, but concurrently with the current developments, many
companies from other countries have successfully produce the same drug at a cheaper
cost.
Clause patent protection in TPP agreement is not much different from the existing
rules in Malaysia. Under the TPP agreement, the countries involved should extend patent
protection only if there is a delay. For your information, most of the research and drug
discovery in various diseases ranging from US. Giant companies they produce drugs for
chronic diseases such as cancer, HIV, hepatitis, viral infection, STD. These companies are
the original manufacturer of these medicines and they have made it their copyright.
If we could just buy these medicines from the original company, and are
prohibited from buying from other countries, the cost of obtaining drugs would be very
high. If the government is now able to provide these medications free of charge to
patients, with higher prices the government will probably no longer be able to distribute
free of charge. Patients who need these drugs need to spend money themselves because
the government does not able to bear the cost of these drugs.However, concern various
parties to the TPP as drugs price increases; has confirmed that the TPP should not prevent
public access to the selection of drugs and health care services affordable. Patent
medicines will remain for 20 years and has not led to major changes to country.
However, there are also aspects of the TPPA potential to trouble the local people.
Among these are period patent to issue such drugs will be increased in duration from 20
years to 25 years. As a result, generic drugs are much lower price will not be supplied to
the patient so that the patient will have to pay high costs for drugs patented by foreign
companies this. In the TPPA, stated that each country should buy original drugs only to
protect the original copyright. If any party in the country trying to buy a non-original
drug, legal action can be taken TPPA will lead to the use of the original patent drugs
compared with generic drugs thus resulting in increased medical costs many times over.

2.1.3 Findings
Health organizations not only from Malaysia, but also from around the Asia Pacific and
other regions have been warned about some action in respect of intellectual property (IP)
proposed in the TPPA. It aims to ensure huge profits for multinational companies, whereas the
price becomes more expensive for ordinary people to get affordable medicines. Prices for
medicines are higher, making it difficult to achieve by the poor and middle class. For example,
new drugs for hepatitis C is now worth more than RM300,000 for the treatment of 12 weeks.
Community Acquired Pneumonia (CAP) concerns on many issues related to negotiated
chapters in the TPPA. For example, in TPPA countries such as Malaysia pressured to agree with
the provisions of the patent would result in delay the entry of generic medicines at affordable
prices in the market Malaysia, where generic drugs are recommended by pharmacist formed
84.7% of the prescriptions. If this provision is agreed upon, Malaysians will have to pay a higher
price for drugs for a longer period of time.
Local generic drug companies will find it more difficult to sustain and importing much
cheaper generic drugs will also be difficult and slow. This will deprive patients of their right to
Malaysia to gain access to treatment, and causes many unnecessary deaths and serious disease
untreated will continue. The effect will be difficult for low and middle income patients because
of the cost to get the drugs to be very high. Imagine if a teacher is suffering from cancer which
requires medications worth RM7000 a month, are they capable of paying medical costs
expensive? What is the fate of many people in our country later?
Pharmaceutical giant will get the rights to the patented drugs, while holding the copyright
for longer with an easier way. This will delay the production of generic medicines and the use of
drugs for chronic diseases and delayed access to medicines for diseases such as cancer, HIV and
chronic diseases other. For example, Herceptin, which is used for cancer nowadays requires
RM8,000 per treatment and requires 17 cycles. The average cost for the treatment of lung cancer
patients could reach RM44,725 (US $ 14,455) per year, per patient. Opportunities for treatment
of these drugs on the wane, especially for those who can not afford because the price is too high,

when access to generic drugs is delayed through the TPP because developed countries will
increase the life span of patents over the last 20 years.
For Human Immunodeficiency Virus (HIV), Highly Active Anti-Retroviral Therapy
(HAART) is a drugs that is needed until the end of life. HAART is well known for its very high
price, even today we still get supply from other producers. Imagine if we could only buy original
drugs that cost 100 times higher. Versions of patented medicines to treat HIV / Aids, for example,
costs $ 15,000 per patient per year, while the generic version costs only USD 67 per patient per
year.
2.1.4 Message for government
While there are many products and services are monopolized by a party in order to
prevent users with higher prices. Government guarantee that the price of products such as
medicines are not increase after TPP implemented and those agreement will give consumers to
choose the best products and services at the same price and possibly less after TPP implemented.
2.2 Issue : Rights for Educational Resources
2.2.1 Cause : Stated in Following Chapter
2.2.1.1 CHAPTER 10 CROSS-BORDER TRADE IN SERVICES
Article 10.9: Recognition
For the purposes of the fulfilment, in whole or in part, of a Partys standards or
criteria for the authorisation, licensing or certification of service suppliers, and subject to
the requirements of paragraph 4, it may recognise the education or experience obtained,
requirements met, or licences or certifications granted, in the territory of another Party or
a non-Party. That recognition, which may be achieved through harmonisation or
otherwise, may be based on an agreement or arrangement with the Party or non-Party
concerned, or may be accorded autonomously.
1. If a Party recognises, autonomously or by agreement or arrangement, the education or
experience obtained, requirements met, or licenses or certifications granted, in the
territory of another Party or a non-Party, nothing in Article 10.4 (Most-Favoured-Nation
Treatment) shall be construed to require the Party to accord recognition to the education

or experience obtained, requirements met, or licenses or certifications granted, in the


territory of any other Party
2. A Party that is a party to an agreement or arrangement of the type referred to in
paragraph 1, whether existing or future, shall afford adequate opportunity to another
Party, on request, to negotiate its accession to that agreement or arrangement, or to
negotiate a comparable agreement or arrangement. If a Party accords recognition
autonomously, it shall afford adequate opportunity to another Party to demonstrate
that education, experience, licences or certifications obtained or requirements met in
that other Partys territory should be recognised.
2.2.2 Effects
The measures proposed in respect of intellectual property TPPA will also pose some risk
of harm from the limited buffer copies and website resources besides that unauthorized use of
digital resources and limit public access to education, research and cultural knowledge that are
digitized, to the extent to criminal copyright of small scale infringement.
Developing copyright to textbooks, journals, scientific information and digital
information to be expensive for a longer period. Students and other Malaysians have to pay a
high price for their books and information material.
2.2.3 Findings
The public has yet to get assurance that the TPPA would involve limitations and
exceptions to intellectual property rights needed to balance the interests of consumers and
copyright owners. In other words, the proposals put forward at this time do not reflect the
balance that is often propagated by supporters of the rights of intellectual property - between
protecting resources as IP and reward creativity and innovation for owners of intellectual
property, in general, and ensure that the public can access the knowledge and information based
on the interest and usefulness.
These include the 'digital commons' or digital common property resources such as
information from the Internet. Copyright law will now be extended from 50 to 120 years. That is,
70 years later access to the students and the academic world are difficult, as the price of
reference books and information resources that are so high.

2.3 Issue : State to State Dispute Settlement (SSDS)


2.3.1 Cause : Stated in following chapter
2.3.1.1 CHAPTER 28 DISPUTE SETTLEMENT
Article 28.6: Good Offices, Conciliation and Mediation
2.

Proceedings involving good offices, conciliation or mediation shall be confidential


And without prejudice to the rights of the Parties in any other proceedings.

Article 28.21: Private Rights


No Party may provide for a right of action under its domestic law against any
other Party on the ground that a measure of the other Party is inconsistent with its
obligations under this Agreement, or that the other Party has otherwise failed to carry out
its obligations under this Agreement.
2.3.1.2 CHAPTER 9 INVESTMENT
Article 9.8: Transfers
1. Each Party shall permit all transfers relating to a covered investment to be made
freely and without delay into and out of its territory. Such transfers include:
(a) contributions to capital;
(b) profits, dividends, interest, capital gains, royalty payments, management fees,
technical assistance fees and other fees;
(c) proceeds from the sale of all or any part of the covered investment or from the
Partial or complete liquidation of the covered investment;
(d) payments made under a contract, including a loan agreement;
(e) payments made pursuant to Article 9.6bis (Treatment in Case of Armed Conflict
or Civil Strife) and Article 9.7 (Expropriation and Compensation); and
(f) payments arising out of a dispute.
Article 9.18: Submission of a Claim to Arbitration
1. If an investment dispute has not been resolved within six months of the receipt by the
respondent of a written request for consultations pursuant to Article 9.17.2
(Consultation and Negotiation):
(a) the claimant, on its own behalf, may submit to arbitration under this Section a
claim:
(i) that the respondent has breached:
(A) an obligation under Section A;
(B) an investment authorisation; or
(C) an investment agreement; and
(ii) that the claimant has incurred loss or damage by reason of, or arising out of,

that breach; and


(b) the claimant, on behalf of an enterprise of the respondent that is a juridical person
that the claimant owns or controls directly or indirectly, may submit to arbitration
under this Section a claim:
(i) that the respondent has breached:
(A) an obligation under Section A;
(B) an investment authorisation; or
(C) an investment agreement; and
(ii) that the enterprise has incurred loss or damage by reason of, or arising out of,
that breach,
Article 9.22: Conduct of the Arbitration
1. The disputing parties may agree on the legal place of any arbitration under the
arbitration rules applicable under Article 9.18.4 (Submission of a Claim to
Arbitration). If the disputing parties fail to reach agreement, the tribunal shall
determine the place in accordance with the applicable arbitration rules, provided that
the place shall be in the territory of a State that is a party to the New York
Convention.
2. A non-disputing Party may make oral and written submissions to the tribunal
regarding the interpretation of this Agreement.
3. Without prejudice to a tribunals authority to address other objections as a preliminary
question, such as an objection that a dispute is not within the competence of the
tribunal, including an objection to the tribunals jurisdiction, a tribunal shall address
and decide as a preliminary question any objection by the respondent that, as a matter
of law, a claim submitted is not a claim for which an award in favour of the claimant
may be made under Article 9.28 (Awards) or that a claim is manifestly without legal
merit.
Article 9.24: Governing Law
1. Subject to paragraph 3, when a claim is submitted under Article 9.18.1(a)(i)(A)
(Submission of a Claim to Arbitration) or Article 9.18.1(b)(i)(A), the tribunal shall
decide the issues in dispute in accordance with this Agreement and applicable rules of
international law.34
2.3.1.3 CHAPTER 17 STATE-OWNED ENTERPRISES AND DESIGNATED

MONOPOLIES
ANNEX 17-B PROCESS FOR DEVELOPING INFORMATION CONCERNING
STATE-OWNED ENTERPRISES AND DESIGNATED MONOPOLIES
9. In making findings of fact and its initial determination, the tribunal should draw
adverse inferences from instances of non-cooperation by a disputing Party in the
information-gathering process.
10. The tribunal may deviate from the time period set out in Chapter 28 (Dispute
Settlement) for the issuance of the initial determination where necessary to
accommodate the information-gathering process.
2.3.1.4 Secret TPP treaty: Environment chapter for all 12 nations
WikiLeaks release: January 15, 2014
Chapter SS Environment
Equivalency in Scope of Coverage
1. Before initiating dispute settlement under the Agreement for a matter arising under
Article SS.3 [effective enforcement obligation and non-derogation], a Party (the
initiating Party) shall consider whether it maintains environmental laws that are
substantially equivalent in scope to those that would be the subject of the dispute and
exercise restraint in taking recourse to dispute settlement under this Agreement with
respect to any laws for which it has no substantially equivalent obligation.
2.3.2 Effects
Among the 29 chapters under negotiation in the Trans Pacific Partnership Agreement
(TPPA) by Malaysia and 11 other countries, investment chapter can was most horrible. This most
important issues, as relates to almost all of the discussion. This chapter will restrict the policy
space of the government through the Investor to State Dispute Settlement (ISDS).
ISDS is provision under the investment chapter, which basically allows any company to
drag the government to court to claim damages and compensation. TPPA would strengthen the
"corporate fairness" across all countries on the grounds of "fairness and equality". Is equality and
equal is meant here? In short, the multinationals can be comfortable with the understanding that
no changes to the domestic laws which would adversely affect them, once they begin operations
in TPPA partner countries.

In fact, it is ticket multinational corporations to step up the legal system of a country,


through international arbitration tribunals consisting of three judges; two international judges and
one local judge. For example, if India suddenly found that a certain ingredient in tobacco is
dangerous and decided to ban it, thereby affecting the profitability of multinational tobacco
companies, the company has the right to sue the government by the potential losses they
experienced during the period of their permit operating in Malaysia.
ISDS provisions proposed for TPPA allow foreign investors to challenge the action taken
by the Malaysian government, even decision of the law, regulation or court made in the public
interest such as health or environmental issues on the grounds that the action such has been or
will affect their investments or profits. The legal challenge is made in an international arbitration
tribunal, thus allowing foreign interests bypassing domestic legal and judicial systems of the
countries that they have invested.
In reality, ISDS provisions as contained in the proposal for effective TPPA investment
chapter to authorize foreign companies to ignore and overcome the judicial system, law and local
parliament Malaysia, the Federal Constitution and the division of powers for the federal-state's
unique and historic where it has grown in the past few decades. Decisions made in the
international arbitration tribunal operating under ISDS system has saw foreign investors granted
greater rights than those given to companies and local investors under the country's constitution,
laws and state court systems TPPA nationalized.
Admittedly, TPPA are an opportunity to strengthen the national economy through inward
investment, business, entrepreneurship and injection of external funds. However, in terms of
preparation and internal economic strength of our own society, it can be a threat that could put
local entrepreneurs. Certainly, small entrepreneurs also feel concern. One thing to be noted is
that when there are trade and investment liberalization, then many organizations will face more
intense competitive pressures. As a result there will be companies that have had to be closed
because of unbeaten in the competition or that losses had to relocate to other countries that the
cost of labour was lower. The result is an increase in the unemployment rate in the country
carrying out the operation at the beginning as jobs were lost.

Operators and manufacturers of the United States is expected to increase investment in


countries such as Malaysia. This is to enable them to enjoy lower operating costs with local
regulations may be more loose and re-export to America and enjoy tariff elimination. Benefits for
our country is to increase employment opportunities. But who will fill these career opportunities?
At the time of technocrats and bureaucrats have the opportunity to enjoy the local income and
better benefits, who will fill the post of labour? Then there is the fear will increase the influx of
foreign labour in the country. Their influx will also be associated with an increase in social
problems in the country
2.3.3 Findings
We need to learn from Mexico who have been through this horrific experience of the
implementation of the North American Free Trade Area (NAFTA), the free trade agreement
(FTA) similar to TPPA signed by the South American countries, Canada and the United States
(US). So far, Mexico's suit against 14 billion ringgit of foreign investors who filed under Chapter
11 of NAFTA, which is a provision to protect foreign investors and facilitate the resolution of
investment disputes. An example of a case filed against the Mexican government involving the
US waste management company, Metalclad Corporation. Metalclad filed a lawsuit in 1996
NAFTA tribunal after the state of San Luis Potosi in Mexico refused to give permission for the
company to reopen a waste management plant after a geological audit showed the plant would
contaminate the local water.
According to Metalclad, the Mexican government was violating Chapter 11 of the
NAFTA and confiscation or expropriation of the company's profits. The company is seeking US
$ 90 million (RM330 million) in compensation. The Tribunal decided in favor of Metalclad and
ordered Mexico to pay compensation of US $ 16.7 million (RM61 million). And now, about the
proposed investment in the US, TPPA by using the same mold as NAFTA, which provide
extreme protection to foreign investors. The Australian government also sued British American
Tobacco (BTA, Dunhill cigarette brands) in 2012 for introducing a law - based on the
recommendations of the World Health Organization - which requires tobacco companies to use
plain packaging without branding and brand to prevent more people die from smoking.

However, the Australian government's action was regarded as a violation of their right
BTA where intellectual property rights (ie brands and trademarks) they seem to be confiscated
without compensation. Despite losing in the Australian courts, the giants continued their
campaign to prevent other countries from doing the same as Australia. By using this case as a
reference, Philip Morris International also filed a lawsuit against the Australian government, not
in the Australian courts, but in international courts with a mechanism Investor-State Dispute
Settlement (ISDS). This mechanism allows large international companies seek compensation
from a country that introduced legislation perceived harm it. The case is still ongoing. So, if
Malaysia signed TPPA, we may also receive the same effect as Mexico and Australia.
In addition, the proposed investment of the US also gives foreign investors the right to
challenge a try or TPPA countries have introduced capital controls or other financial rules whose
purpose is solely to ensure economic stability to the country. Malaysia introduced capital
controls after the recession in 1997 when the then Prime Minister, Tun Dr Mahathir Mohamad
aware of the financial crisis was caused by currency speculators conspiracy that nearly brought
down our economy.
Under the TPP, if we sign a version that is being negotiated now, we may not be able to
protect our economy use the same way if he again attacked currency speculators, thus exposing
the country to the manipulation of the increasingly sophisticated financial world today. Concerns
over this matter has caused more than 100 economists from around the Asia Pacific in a letter in
2012 warned their governments about the dangers of the provisions in the agreement, particularly
the issue of capital controls. Finally, the presence of foreign banks have will exacerbate
inequalities in people's welfare. Majlis Tindakan Ekonomi Melayu Berhad (MTEM), the
investment chapter should not exist at all in the TPPA and if there are any, the definition of
'investment' needed to be clarified, and should be limited to only certain projects.
TPPA aims to liberalize trade and reduce tariffs, which can cause drastic loss of jobs in
many sectors. The direct effect is downward pressure on workers' wages, income gaps widen an
already large current. Mexico is the best example; as a result of the signing of the North
American Free Trade Agreement (NAFTA) with Canada and the United States, three million of
the ten million Mexicans lost their jobs. Tariff reductions will impact particularly on agricultural

products. How glorious was the intention TPPA promote efficiency and healthy competition, the
intention of it being unfair when we look at the fact that over 90 per cent of Malaysian
companies involved in the agriculture sector are small and medium enterprises (SME). They will
face unequal competition from giant agricultural companies from countries such as United
States, Canada and Japan, where the government does not reduce the huge subsidies to their
farmers.
The study by United Nations Conference on Trade and Development (UNCTAD) shows
that subsidies reduce the cost of US rice production by 45 percent, soybeans by 32 percent and
cotton by 52 percent. A rough calculation shows that their rice to meet market Malaysia as low as
RM1.40kg. What will happen to Bernas, and the fate of the smaller local producers?