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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