Archive for January, 2009

Monitoring the Affordable and Quality Medicines Act

Posted on January 28, 2009. Filed under: News |

PRESS BRIEFING
(with Cut the Cost, Cut the Pain Network and Cancer Warriors Foundation)
January 21, 2009
MAX’s, Ma. Orosa cor. U.N. Ave., Manila

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AYOS NA GAMOT SA ABOT-KAYANG PRESYO (AGAP), a multi-sectoral coalition composed of health professionals, labor unions, civil society organizations, consumer groups and public health workers, would like to commend the Department of Health for clearly defining the role of the Civil Society Groups in the implementation of the Affordable and Quality Medicines Act of 2008 (Republic Act 9502). After the publication of the Implementing Rules and Regulation, sometime in November of last year, it is worth noting that the DOH has indeed taken steps to ensure the law’s effectivity such as the setting up of a preliminary meeting on the creation of the Advisory Council for Maximum Retail Price (MRP) which we, the Civil Society Groups, are made part of. And we are happy with this positive development.

We, nevertheless, urge the Department of Health to formally deputize the Civil Society Groups as members of the advisory council and outline their mandate through an Administrative Order or Terms of Reference as a manifestation of the CSOs’ authority to monitor the implementation of the law and for transparency.

Further, we would like to encourage the Department to convene more Advisory Councils on other areas of concern, to name a few: quality and safety of drugs and medicines and implementation of cost-containment measures. Creation of such councils would facilitate the effective implementation of the law and the IRR. With this, AGAP calls on the DOH to again involve the civil society and ensure their active participation and adequate representation in these Councils.

Notwithstanding the efforts of the Department of Health, let us not forget that this new law was designed primarily to incorporate the TRIPs flexibilities into our own Intellectual Property law to promote a level playing field in the Pharmaceutical Industry, encourage meaningful competition and thus, make medicines more affordable and accessible. We now take this opportunity to familiarize ourselves with the developments or the efforts taken in terms of implementing the Intellectual Property part of the law.

During the public hearings, the Intellectual Property Office expressed their intent to amend the Patent Examiners Manual to make it conform to the law and the IRR. Thus, we would like to be informed of the initial steps taken by the IPO on this matter. We strongly urge the IPO to make use of the TRIPs flexibilities to its full extent and to always refer back to the law’s policy of promoting the primacy of public health in amending or developing any of their internal procedures.

As we always say, the campaign for greater access to medicines did not end with the passage of the law or with the publication of the IRR. More can and should be done. AGAP pledges its support to the various government agencies for the efficient enforcement of the measure and commits to continue with its efforts in advocating for people’s greater access to medicine.

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AGAP joined Safe Medicines Network (SMN)

Posted on January 27, 2009. Filed under: News |

Ayos na Gamot sa Abot-Kayang Presyo (AGAP) joined the safe Medicines Network (SMN)last November 13, 2008 at the Filipinas Heritage Library in Makati City.

SMN is a multi-sectoral alliance advocating for safe and quality medicines in light of the proliferation of fake medicines.

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Addendum to the NGO’s Technical Review of the Draft Implementing Rules and Regulation of Republic Act 9502

Posted on January 26, 2009. Filed under: Resources |

We, Ayos na Gamot sa Abot-Kayang Presyo (AGAP), Cancer Warriors Foundation, Cut the Cost Cut the Pain Network (3CPNet), and Third World Network (TWN), are submitting these additional points for the R.A. 9502 IRR drafting committee’s consideration:

AMENDMENTS TO THE INTELLECTUAL PROPERTY CODE

1. We would like to reiterate that the rules must enable the government to use public health flexibilities under the TRIPS, without any impediment to safeguard and promote public health. More importantly, we wish to clarify that we are NOT IN FAVOR OF ANY TRIPS PLUS PROVISION.

2. We are NOT IN FAVOR OF DATA EXCLUSIVITY. That is totally against our objective to allow early working of a patent. In fact, in page 11 of our earlier submitted IPO IRR technical review, we recommended the DELETION OF THE WHOLE RULE ON DATA PROTECTION AND REPLACE IT WITH THE EXACT TEXT OF ARTICLE 39 OF THE TRIPS AGREEMENT. The proposed Rule on Data Protection is misnamed. in Art. 39.3 of TRIPS, there is no such thing as data protection, what we have there is protection against unfair commercial use; we are concerned about this creeping insertion of the concept of data protection when such is not the intent of the provision at all. If one refers back to the IP Code (RA 8293) in sec. 4 (g), there is only the undefined concept of “protection of undisclosed information”, it might be useful to just use that term than a simplistic “data protection” phrasing, as it can be easily used as a template which can be expanded later in case our commitments in, for example, the Japan Philippines Economic Partnership Agreement (JPEPA) kicks in, and this will defeat the purpose of the law in promoting broader access to medicines.

The removal of the concept of data protection will also remove the necessity of defining what is data, for as it is written now it is so broad; but if it has to be defined then perhaps that part on the oral or verbal, including digital recording or electronic should be removed; data here as a concept should be narrowed, to only refer to test data that is being used in the drug approval process, nothing else.

On the second sentence of the proposed rule on data protection, what is unfair commercial use, again, this is a misapplication or maybe a misapprehension of footnote 10; said footnote,l refers to what is referred to in 39.2 TRIPS as “manner contrary to honest commercial practices” which is very different from what is unfair commercial use; legally, there is a problem citing art. 39.2 when the Cheaper Medicines Law explicitly refers only to art. 39.3 of the TRIPS Agreement.

3. We recommend that the IRR should state the procedures for the conduct of Parallel Importation and the application of the Bolar Provision. We have included proposed language on said procedures in our earlier submitted IPO IRR technical review which can be found in page 9 and 11 respectively.

We would also like to further recommend that should the drafting committee consider the need for procedures in a different document or instrument such an Administrative Order, there should be an EXPRESS PROVISION in the IRR that states that the concerned government agency WILL come up with a separate guidelines or procedure for the conduct of Parallel Importation and Application of the Bolar Provision.

4. We also would like to reiterate that there should be a common definition of the word “efficacy” since the IPO draft and the DOH draft differs therewith. We propose that the DOH should determine the efficacy of medicines and this should bind the patent examiner in deciding to grant a patent.

5. We also further reiterate our position calling for the deletion of the provision on the IPO IRR on preservation of existing rights. As this will render the law useless in enforcing parallel importation, government use license, Bolar exception on existing patents; and, equally important, is the opportunity to challenge existing patents based on the new law.

AUTHORITY TO IMPORT

6. We wish to clarify our position on coursing third party importation through PITC. Our purpose for proposing such is to allow non government organizations and patients groups who have limited capital to purchase in bulk. This proposal is deemed to be only optional and not mandatory. That the PITC may enter into MOUs with said groups to help them access medicines that are needed by their organization, which we believe will not be used for commercial purpose.

MAXIMUM RETAIL PRICE

7. We recommend that there be a provision that will guard against the possible price increases of medicines to move near the Maximum Retail Price (MRP) since the only prohibition in the IRR is not to sell beyond the MRP. We see this problem occurring because of the natural tendencies of retail stores to increase prices of low-cost drugs as an alternative for the decrease in the prices of high-cost drugs brought about by the setting of the MRP.

8. We reiterate our position for the inclusion in the factors for determination of MRP the patient’s capacity to buy and transfer pricing.

9. We propose that the rule on PhilHealth actions shall explicitly state that consultations with patient groups will be conducted to aid specifically in determining the patient’s capacity to pay.

Finally, we wish that in case of any conflict or reservations, the drafting committee will refer back to the law’s declaration of policy to protect public health.

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NGOs: ‘Cheaper medicines’ IRR fall short. No parallel importation, drug developmen

Posted on January 26, 2009. Filed under: News |

By Dona Pazzibugan
Published by: Philippine Daily Inquirer
First Posted 21:52:00 10/30/2008

MANILA, Philippines — Civil society groups have complained that the
draft implementing rules and regulations (IRR) for Republic Act No.
9502, or the Cheaper Medicines Law, appear to not fully reflect the
core provisions of the landmark legislation.

The groups, Cut the Cost Cut the Pain Network (3CPNet), Oxfam and Ayos
na Gamot sa Abot Kayang Presyo (AGAP, Proper Medicines at Affordable
Prices) said the draft IRR do not contain rules on “parallel
importation,” which would allow the government and private groups to
import patented medicines from countries where they are sold cheaper.

They said the draft also did not specify how local generic drug
manufacturers could make use of the “early working principle” that
would allow them to begin developing medicines even before their
patents expire.

RA 9502, or the Universally Accessible Cheaper and Quality Medicines
Act of 2008, was signed into law in June after years in the
legislative mill.

The law seeks to bring down the prices of medicine by encouraging more
competition in the local market mainly through the parallel
importation of cheaper quality drugs.

The Department of Health and Intellectual Property Office have ended
public consultations and are expected to issue the IRR on November 4.

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NGOs’ Submit Technical Review of the DOH and IPO Draft IRR

Posted on January 26, 2009. Filed under: Resources |

Ayos na Gamot sa Abot-Kayang Presyo, together with the other Civil Society Groups, made a technical review of the draft implementing rules and regulations made by the Department of Health and the Intellectual Property Office. Said reviews were submitted to the named government agencies.
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Technical Review of the Draft Implementing Rules and Regulations
(IRR) of Republic Act 9502

SUMMARY OF RECOMMENDATIONS

This is a joint submission to the Intellectual Property Office by different international and local civil
society groups- Ayos na Gamot sa Abot Kayang Presyo, Cancer Warriors Foundation, Cut the Cost
Cut the Pain Network, OXFAM and Third World Network.

The technical review focused on Chapter 2 of Republic Act 9502, and is based on the draft IRR
presented by the Intellectual Property Office, and cross-referenced with the draft IRR of the
Department of Health. The group’s technical review on the draft IRR of the Department of Health is
found in a separate paper.

Below are 28 key recommendations by different civil society organizations seeking to ensure that
public health always takes precedence over intellectual property rules. This means that the IRR
must enable the Government to broadly use public health flexibilities under TRIPS without any
impediment to safeguard and promote public health. In particular, the government – through its
implementing agencies – or the Intellectual Property Office and the Department of Health, should
have the ability to use safeguards to ensure generic medicines can enter the market immediately
upon patent expiration, to ensure that governments can override patent protection to introduce
inexpensive versions of medicines to protect public health, or to import a patented product
marketed in another country at a lower price (parallel importation).

Rules on Construction
1. We recommend to retain the law’s provision on Construction and not add any modifications as
shown in the draft IRR of the IPO. (A1)

2. We recommend adopting the version of the Department of Health’s draft of the IRR where it
retained the law’s Declaration of policy and Construction provisions. (A1)

Rules on Non-Patentable Inventions and Inventive Step

3. We recommend that the DOH should determine the efficacy of medicines and this should bind
the patent examiner in deciding to grant a patent. (B1)

4. The proposed rule requiring IPO to defer to the decision of DOH on determination of significant
efficacy is only applicable to patent applications for known substances, processes, and any other
derivatives of the known substance.

5. We recommend the deletion of the three new provisions on efficacy under (Roman Numbers 2-
4, under the Rule on Inventive Step. Refer to Draft IRR, page 3. (C1)

6. Efficacy should be defined in relation to its therapeutic effect on the body. (C2)

7. We propose that the guideline in determining efficacy should include the following:
a) Determine the efficacy of patent applications with regard to its healing and therapeutic effect
on the body e.g., including its side-effects and long-term effects;
b) The determination of efficacy shall be made on a case-by-case basis with a ‘statistically
significant sample’ of the population that will be using such drug or medicine
c) It should always be done in comparison with all existing drugs of the same therapeutic
category or sub-category available to the public at the time of the patent application.
d) Submission of related comparative test results should be a requirement. This should also
include an independently verifiable study to establish the credibility and integrity of the
patent applicant’s results of clinical trials.

8. In relation to the law’s provision on the determination of efficacy, and to make the rules
consistent with the proposal to have a credible expertise and authority – such as the Department
of Health, to asses efficacy, we find it necessary to amend the rules pertaining to prior art and a
person skilled in the art when it comes to drugs and medicines. (C5) Particularly, we recommend
the following rules:
a. That a person skilled in the art under this Rule, in the case of drugs and medicines, shall
have a doctorate and post-doctorate degree in the sub-field or sub-area of the drug or
medicine covered by the patent application.
b. That prior art under this rule shall also consider unity of invention and mosaicing, which
refers to the combining of documents to establish the lack of inventive step of the patent
application.

9. Reinstate the phrase “any new property or” that may have been inadvertently deleted. Refer
to Page 2, Draft IRR, Rule [ ]: Non-Patentable Inventions, between the phrase “or the mere
discovery of” and “new use for a known substance….” (B3)

10. Reinstate the word “new” that may have been inadvertently deleted. Refer to Page 3, Draft IRR
Rule [ ]: Inventive Step, between “or the mere discovery of any” and “property or new use for a
known substance, ….” (C7)

Rules on Introduction of the Patent Exhaustion
11. We recommend deleting the following words “donation, promotion, advertising, medical
prescription or” as one of the ways of introducing a product in relation to international
exhaustion principle, as shown below. (D1)

12. We propose that the following guidelines and procedures on the conduct of parallel importation
be reflected in the IRR. (D2)
(a) That government purchases should be done through the PITC
(b) That third party or private sector parallel importations of drugs and medicines have the
option to course it through the PITC, other than directly importing on their own.
(c) The IRR draft of the Department of Health should specify that the retained income of BFAD
(as provided under Chapter 4 of RA9502) shall allocate a portion of it to support the
registration and testing of parallel imported drugs.
(d) Third parties should NO longer be required to undergo a separate and distinct accreditation
process nor secure any clearance from the IPO, other than the usual business registration at
BFAD.

Rules on Limitation of Rights to allow experimental use
13. We recommend adding criteria on determining what activities qualify as an experimental use for
scientific or educational purposes and other related activities, as this will allow clearer
implementation of the law, and will entice research and development activities. (E1)
Rules on Data Protection & Bolar Exception

14. We recommend deleting the whole rule on data protection and replace it with the exact text on
Article 39 of the TRIPS Agreement, since this is consistent with minimum standards under
TRIPS. (F1)

15. We also see the need to supplement Article 39 of the TRIPS Agreement with guidelines on a)
determining unfair commercial use, b) determining eligibility for data protection, and c) nature
of data protection. (F2)

16. We also note the need to state the primacy of public health interests over claims for data
protection. Patent holders may not claim data protection from unfair commercial use over public
health concerns. (F4)

17. We also note the need to explicitly state a procedure to guide pharmaceutical companies in
applying for the early working of patents, or the Bolar exception. The procedure on how to apply
early working of a patent must contain the following: (F5)
a. That the data sought to be protected from unfair commercial use should be disclosed to the
Bureau of Food and Drugs (BFAD).
b. That the data submitted by the originator may be used by the applicant for a generic
equivalent at anytime within the life of the patent.
c. That the process of using the data of the originator brand for the registration of a generic
equivalent at the drug regulatory agency (i.e., BFAD) is independent and separate from the
process of any petition invoking data protection that may arise and should be filed at the
Intellectual Property Office. As such, the registration process at BFAD shall continue unless
the IPO rule that it constitutes an unfair commercial use.

Rules on Government Use
18. We value the provision that exempts government use license from following the rules and
procedures prescribed for a compulsory license.

19. We recommend that all rules and procedures referring to a government use license should be
grouped under one section to allow easier understanding and facilitate better implementation.
(G1)

20.We recommend having explicit rules on the Scope and nature of the Supreme Court’s authority
to issue injunctions. (G2)

We only hope that the Supreme Court will issue specific rules that will define how
and when it will only intervene in these cases so that the public’s access to medicines will
not be impaired, and will only apply injunctive relief in extraordinary circumstances.

21. Reinstate the law’s provisions concerning judicial review, and the issuance of temporary
restraining orders (TROs) or injunctions.(G2)

22. We recommend having explicit rules on determining adequate compensation, and basis for
computing royalty rate. (G4)

The rate may be based on the 2001 UNDP Human Development Report recommendation
of a maximum royalty rate of 4% of the price of the generic product, or through a tiered
royalty method (TRM) where the royalty is based on 4% of the high-income country price,
adjusted for the relative income per capita of those facing the disease in the Philippines.

Rules on Compulsory License
23. We recommend having a provision clarifying who may petition for the three types of procedures
on compulsory license (including Special Compulsory license) provided in the IRR. (D1)

24.We propose that the periods set in processing petitions for a compulsory license on the ground
of national emergency or public interest, be made non-extendible to expedite the process of
approval for compulsory licenses. (D2)

25. We recommend deleting the requirement of identifying the number and date of issue of the
patent in the form and contents of the petition. (D3)

Rules on Special Compulsory License
26.We recommend embedding the whole text of the WTO decision in the IRR, since it appears that
document reference number WT/L641 appears to be an invalid or an unrecognizable document
in the WTO website. (I1)

27. We recommend adding a rule allowing any person or group to petition the Department of Health
and cause the latter (DOH) to review and recommend a special compulsory license, if found
meritorius. The decision to reject or recommend the petition should be settled within reasonable
time by the Department of Health.

Rules on Preserving Existing Rights
We strongly urge the Intellectual Property Office to delete this provision on preserving existing
rights as it will render the law useless in enforcing parallel importation, government use license,
Bolar exception on existing patents; and, equally important, is the opportunity to challenge existing
patents based on the new law.

FULL TEXT of the CSO Technical Submission:
On IPO IRR
On DOH IRR

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