Archive for July, 2010

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

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

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 or call our Program Officer at 372-39-91 loc. 30.

Looking forward to continued partnership with your office.

Thank you.

Original Signed
Angelito Mendoza

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