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Joint Position Paper of AGAP, CWF and 3CPNet on DOH’s Phil. Medicines Policy

Posted on July 28, 2010. Filed under: Resources |

26 July 2010

Hon. Alexander Padilla
Undersecretary for Health Regulations
Program Executive Officer
NCPAM – DOH

Dear Usec. Padilla:

Ayos na Gamot sa Abot-Kayang Presyo (AGAP), Cancer Warriors Foundation (CWF) and Cut the Cost, Cut the Pain Network (3CPNet) would like to extend our gratitude for the partnership opened and productively sustained with your office through the Advisory Council of which we all are active members.

We would also like to thank you for the opportunity given to us to react and share our views on the Philippine Medicines Policy 2010 (PMP) draft, sent late last week.

After a careful study of the PMP paper, we generally agree with the framework of the policy and its key components with some comments and observations on the following:

On Safety, Efficacy and Quality

1. The Food and Drugs Administration (FDA) plays a vital role in the implementation and success of the PMP especially in ensuring quality of medicines and this role cannot be ignored. Thus, the necessity to conduct open public hearings on the long overdue implementing rules and regulations of the FDA Law as well as its immediate finalization is timely called for.

2. We agree that there must be an efficient and effective system for monitoring adverse drug reactions through the proposed National Pharmacovigilance Policy. However, to make this proposal work better, the role of patients and consumers in the reporting process must be highlighted. A program educating them on how and where to report should be made to capacitate them to be active participants in this post surveillance mechanism. A 24 hours call center and a user-friendly internet ‘feedback’ form are only some of the recommended ways that can be used for timely and competent reporting.

3. We very much support anti-counterfeiting measures on medicines to ensure patient safety. We would like to encourage a strong public-private partnership on the matter as we are aware that there are already groups such as the Safe Medicines Network, where AGAP is a part, who recently conducted training to Barangay Health Workers on counterfeit.

But despite the good intentions of the proposed act, we would like to stress the need to be extremely vigilant and cautious over any and all international interventions on the matter. Recent developments in the global arena reports that access to medicines is threatened by the Anti-Counterfeiting Trade Agreement (ACTA), an agreement in the guise of protecting public health but in reality, may possibly limit Intellectual Property Rights flexibilities and hamper transit of low cost medicines.

On Access and Availability

4. We concur that promotion of generics medicines is one important key in attaining access. In this connection, we would like to emphasize that the civil society are willing to help in the generics information campaign of the government in the different communities and localities, with those in the grassroots as the target audience.

Apart from the information campaign, we acknowledge that the main issue raised as regards the use of generics is an issue of quality, thus, the need to strengthen the FDA and call for the implementation of strict quality assurance regulations.

We also agree that effective market competition is essential to provide access to medicines and the WTO TRIPs flexibilities, now incorporated in the Cheaper Medicines Law is expected to respond to the call of fair and just trade in the pharmaceutical market. Unfortunately, two (2) years after the passage of RA 9502, the promised amendments of the patent manual for substantive examination of the Intellectual Property Office is still not in place. We, therefore asks the Dept. of Health as the lead agency implementing the Cheaper Medicines Law to call the attention of the IPO for the latter to work in close coordination with the department and fulfill their unsettled tasks. The amendment of the patent manual will hopefully prevent the issuance of frivolous patents and will bring to an end cases like that of the Pfizer vs. Unilab on ‘Atorvastatin’ that in one way or another, curtailed the people’s right to access lower priced generics medicines.

5. As active members of the Advisory Council, we would like to propose that the council’s function be not limited to merely drug prices but include quality of medicines as well as other health care concerns. We believe that transparent consultations are important in achieving good policies and regulations.

Moreover, the expansion should include more patient groups on various diseases who, because of their own expereinces as well as advocacies, can enlighten the health implementers and the rest of the stakeholders on the reality of accessing health care with respect to their specific sector.

6. On the issue of medicine taxes, we would like to suggest that these be subjected to intensive study and scrutiny. While we recognize the good intention of the proposition and its supposed outcome of lower costs for medicines, we could not negate the fact that this might have other effects on government’s finances in general and thus, might also have an impact of the department’s budget for health projects.

7. We fully agree that there is a need for sustainable financing to allow the poor to access essential medicines. We would, however, want to be clarified what the term ‘minimum entitlements’ cover. We suggest using the word ‘basic’ instead of minimum to mean that the poor shall be provided with their necessary and primary needs.

We strongly support the lowering of out-of-pocket expenses through the inclusion of out-patient benefit packages under the NHIP and other cost-containment measures. We have been actively advocating for these and in fact, lobbied that it be included in the Cheaper Medicines Law. Unfortunately, it has not been implemented up to this moment despite strong civil society campaigning on the matter. We wish to be assured of the immediate implementation of the cost containment measures, specifically out-patient coverage to ensure that the population really has access to affordable medicines. The P100 program is a good first step but it has obvious limitations which need to be addressed. These limitations include the narrow list of products included in the program/package, its availability is restricted to government hospitals only and that it is allowed as an out-patient benefit only for indigents.

We very much welcome the ‘free medicines for priority diseases/vulnerable groups’ plan because this will not only resolve problems on drug resistance in TB but will also serve as an instrument to prevent prevalence of these transmittable illnesses. Further, the scheme has already been proven useful to childhood cancer patients under partnership of your department with the Cancer Warriors Foundation.

8. On the use of the TRIPs flexibilities, we would like to reiterate our stand that this will only be made effective with the Intellectual Property Office taking an active part in the implementation of policies and programs on drugs and medicines such as this PMP, for reasons already explained in item no. 4 of this document.

9. We put forward the idea of DOH creating an incentive scheme for pharmaceutical companies who provide patient assistance programs to Filipino patients whose illness requires the intake of the so-called “miracle drugs”. This will hopefully encourage pharmaceutical companies to not only create similar patient assistance programs but on the extreme, invest in research and development of new life saving drugs and medicines.

On Rational Drug Use

10. We recommend that the Department of Health should take the lead in rationalizing treatment protocols for diseases like cancer as this will also rationalize the procurement of essential drugs, improve access to life saving medicines and more importantly, help the patients and their families cope with the disease.

11. We would also like to assert that to increase efficiency of the RDU program, a parallel campaign for an extensive and comprehensive patients’ rights to information with an emphasis on appropriate and culture sensitive communications plan for the purpose should be developed.

In connection with this, we propose that the patients, patient groups and civil societies should be allowed to suggest medicines/drugs for inclusion in the essential drug list and that the publication of the Philippine National Drug Formulary and any updates therein be not limited only to the DOH website to ensure that patients, in whatever age, be informed of what medicines are included in the list.

On Accountability and Good Governance

12. We deem it essential that in the implementation of the whole PMP transparency must be employed at all times, thus, our support on the provisions of this sub section. On making data available and accessible to public, however, we would like to recommend that the creation of an information desk under DOH to assist researchers and all the stakeholders find the information they need as regards medicines and health care easily. The desk is expected to harmonize all data and study of the different attached agencies of the Department so that there won’t be a need to go through the different offices just to get the necessary information, thus, saving time and effort.

13. We welcome performance audit mechanisms of health facilities and to ensure accurate and unbiased assessment, patients and their families should at least be interviewed or surveyed, in a random, regarding their satisfaction with the services rendered by the concerned facility.

On Health Systems Support

14. Adequate training must not only be limited to the implementers of the PMP but must also be provided to Barangay Health Workers, patients groups, consumers, and other stakeholder to help the Department efficiently cascade information to the broader groups of the population that will in turn help the DOH make the program a success. The trainings should be specifically designed in accordance with the role that the trainees are expected to perform under the policy.

15. Finally, while the role of the partners has been identified clearly, the civil society would like to restate its call on the ‘deputization of the CSOs to monitor prices of medicines’ which has been previously agreed upon. But because of the great weight that this policy requires for its implementation, we would like to inform you of our willingness to expand the scope of the deputization which may include adverse drug reaction reporting, among others.

In this regard, we request DOH to provide the CSOs deputized a proof of the deputization stating among others that the bearer of the instrument is authorized to ask, check and monitor the program. As have been experienced by the Cancer Warriors Foundation in hospitals that provide free medicines for kids with leukemia, gathering basic facts from government pharmacies and hospital staff proved to be extremely difficult.

We completely support the implementation of this policy by the DOH-NCPAM, in consultation with all the stakeholders. It is timely to put into full use all the provisions of the Cheaper Medicines Law to achieve our common goal of providing our people with greater access to medicines.

We hope you find this in order, but please feel free to communicate with us for any clarifications.

Thank you.

In behalf of AGAP, CWF and 3CPNet,

Paula Mae B. Tanquieng
AGAP Program Officer

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AGAP Position Paper on Expansion of Advisory Council for MDRP

Posted on July 24, 2010. Filed under: Resources |

20 July 2010

Hon. Alexander Padilla
Undersecretary for Health Regulations
Program Executive Officer
NCPAM – DOH

Dear Usec. Padilla:

Ayos na Gamot sa Abot-Kayang Presyo (AGAP) would like to extend our appreciation for the successful partnership with your office under the Advisory Council for Price Regulation.

Based on the proceedings last 6 July 2010 Council meeting, we would like to state the following:

1. We very much welcome and support the call to expand the Advisory Council for Price Regulation into Advisory Council for Safety and Quality of Medicines and Health Care.

The current council focuses merely on affordability of medicines and does not entirely respond to the objectives of R.A. 9502 to increase access to affordable and QUALITY medicines. The expansion is expected to be beneficial in ensuring consumer and patients’ right to safe and efficacious drugs through their active involvement in the creation of regulations for the purpose.

Moreover, we all agree that the Cheaper Medicines Law is a first good step but not an end in itself, as this caters mostly to those people in the middle income group but do not prove to mean access to those in the lower classes. Thus, the need to discuss for other health care strategies that will provide the less fortunate with at least the basic or primary health care package they need. This discourse is hoped to be a part of the Council’s agenda with its expansion into Advisory Council for Health Care.

2. We acknowledge that the Maximum Drug Retail Price (MDRP) has served its purpose of influencing other market players to lower the cost of medicines but as regards your pronouncement to put at halt the implementation of the MDRP, we have the following reservations:

• We fear that products subjected to the government’s price reduction efforts might increase their prices back to its original cost once the program is terminated. This is because there is no law or any other regulation disallowing them not to do so.

This apprehension also applies to those products under the Government Mediated Access Price (GMAP), which in nature is voluntary.

We hope you could do some interventions to avoid, or at least lessen this problem and its possible effects.

• We are also wary that this intervention might have other unforeseen effects that we may have to consider to avoid even the slightest undesirable change in our still recuperating health sector condition.

3. AGAP would also like to take this opportunity to voice out that there are still much to be done – in the implementation of the Cheaper Medicines Law, alone.

AGAP, as part of the Coalition for Health Advocacy and Transparency (CHAT), conducted a forum last 25 March 2010 entitled Citizens’ Assessment of the Cheaper Medicines Law: Identifying Gaps and Direction. In this occasion, the various organizations from the different sectors came up with the following recommendations, among others:

 Call IPO to amend its manual of patent examination to ensure that there would be no more recurrence of cases like the Warner Lambert/Pfizer vs. Unilab/Therapharma on frivolous patents.

 Finalization of the Implementing Rules and Regulations of the Food and Drugs Administration Law.

 DOH should conduct a study apart from the studies of the private sectors in terms of identifying product costs of importation and identify source countries, if found to be more affordable and more cost-efficient, then importation should be done.

 Strengthen enforcement of the existing Generics Law and expand information campaigns to promote generics.

4. Finally, we would like to inform you that AGAP will constantly monitor the implementation of the Cheaper Medicines Law and we will always be open to collaborate with the Department of Health in its efforts to provide our people with access to medicines and health care. With this, we formally express our inclination to become part of the expanded Advisory Council.

We hope everything is in order but please feel free to communicate with us any questions or clarifications from the above statements through email at ayosnagamot@gmail.com or call our Program Officer at 372-39-91 loc. 30.

Looking forward to continued partnership with your office.

Thank you.

Respectfully,
Original Signed
Angelito Mendoza
Convenor

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Pfizer and Mercury Must Respect People’s Right to Access Quality & Affordable Medicines

Posted on December 3, 2009. Filed under: Resources |

We, advocates for greater access to quality and affordable medicines, especially among the marginal sectors of the Philippine society, view with great concern the current issue between local drug company United Laboratories Inc.,(Unilab) and multinational pharmaceutical firm Pfizer Philippines Inc., on the introduction by the former of generic counter-part to the anti-cholesterol drug Atorvastatin, branded and sold locally and worldwide by the latter as Lipitor.

While we welcome the introduction of quality and more affordable generic counterparts to popular innovator brands in the market as Unilab has done with the introduction of their Atorvastatin version, branded and distributed locally as Avamax, it is fairly apparent that based on recent reports and news accounts, Pfizer has again moved to oppose the marketing and distribution of generic versions to Lipitor not only through the usual legal measures but by employing unwarranted business practices and tactics as well.

While we respect valid patent claims of innovator drug companies, we believe that this right is and always will be secondary to the common good or the social need which is more apparent and necessary in a developing country such as ours. Moreover, we decry business practices which abuse the rights given to the patent holders which seek to perpetuate their claims by ever-greening – the frivolous and false introduction of innovations in a product to surreptitiously secure a perpetual and exclusive benefit. Thus, we support all earnest initiatives which seek to challenge patents and uncover such patent rights abuses here and abroad.

Above all, we condemn the use of threats and the alleged bullying tactics employed by Pfizer against drugstores in their effort to hinder the entry not only of competition but more affordable alternatives to anti-cholesterol treatment and medication which would otherwise have made a difference in the life and health condition of the average patient.

We also view with great concern the non- availability of Avamax in branches of the largest drug retail chain in the country, Mercury Drug. Whether compelled by threats by or under any special arrangement with Pfizer, Mercury’s refusal to carry Avamax in their stocks in effect curtails the legitimate right of patients and clients to access quality yet affordable medicines and likewise virtually kill free competition between Lipitor and Avamax. Hence, unwittingly or not, Mercury here plays the role of accomplice in Pfizer’s insatiable drive for super profits.
We call on the Department of Health (DOH) to intervene on the issue in behalf of the millions of patients who would otherwise benefit from greater access to Atorvastatin. We also call on our lawmakers to undertake investigations in aid of legislation in order to further improve on the milestones that the Cheaper Medicine Act and its corresponding implementing rules and regulations were able to bring forth in this continuing effort to bring safe and affordable medicines within the reach of every Filipino patient. Finally, we appeal to the Intellectual Property Office (IPO) and the Bureau of Food and Drugs (now the Food and Drugs Administartion [FDA]) to conduct open public hearings on the Manual of Substantive Examination Procedure which will strengthen the rules on what is or what is not patentable – a key provision in the law that will prevent ever-greening of patents so as to clearly apply to the present controversy.

Ayos na Gamot sa Abot Kayang Presyo para sa lahat ng mga Pilipino!!!

By: Angelito R. Mendoza
Convenor

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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’ 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.
—-

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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