The DOH Advisory Council (AC) for the implementation of RA 9502 (Cheaper Medicines law of 2008) has already met twice this year. The second meeting was yesterday, but I did not know these meetings as I received no invitation. I only received the three documents for comments by the AC members: (1) "Declaration of Conflict of Interest" form, (2) Draft DOH Administrative Order (AO) on the constitution of the AC, and (3) Draft AO, Regulating the promotion and marketing of pharma and medical devices products. The AC Secretariat noted this and promised
to invite me next time.
Here are my comments to those three documents.
1. On the "Declaration of Conflict of Interest".
For instance, pharma companies, innovator or generics,
have the interest of selling more of their products, whether heavily advertised
or not, whether endorsed by physicians or not, and so on. The same can be said
of the drugstores and pharmacies.
Physicians and pharmacists have the interest of giving healthcare, particularly giving effective and safe medicines, innovator or generics, expensive or cheap. The most expensive
medicines are those that do not work, even if the price is only P1 but if it is
substandard, or triggers allergies and negative side effects to the patient, in effect it is an expensive
medicine. It will invite new treatment, new medicines, new diagnostic tests,
new physician pf, etc.
Consumers and patients have the interest of more choices,
more options, among the different medicines, treatment, drugstores, clinics,
hospitals, physicians, etc. If a doctor is expensive but he/she can make the
patient get well the soonest possible, in effect he/she gives good value for
money, "cheap" service.
2. On the draft AO constituting the AC.
a. For the nth time, the DOH and the rest of us should STOP using those terms MDRP (and GMAP). These are illegal terms -- not in RA 9502, not in the implementing rules and regulations (IRR) of the law. What is
clearly, explicitly, categorically stated
in RA 9502 is MRP, maximum retail price. MDRP and GMAP are political inventions by the DOH and DTI (under Secretaries Ona and Favila, respectively) during the last few months of former President GMA. GMAP is
subliminal for Gloria Macapagal Arroyo Price, and not really Government-Mediated Access Price. MDRP was invented to deflect
calling MRP as Mar Roxas for President because then Sen. Mar Roxas was being
desperate to be pro-poor to improve his
low ratings in the Presidential surveys
in 2009.
b. On Specific functions of the AC. RA 9502 is first and foremost, an amendment to the
Intellectual Property Code (IPC) to allow TRIPS flexibilities and hence,
institutionalized the possible imposition of IPR-busting policies like
compulsory licensing (CL), special CL, parallel importation, etc. Price
regulation is just an "add-on" chapter in the law, not even in the
original draft bills. But IPR policy review of the AC is not mentioned in the draft AO.
So I propose that IPR Policy review should be #1 under
Specific functions, #2 is Price regulation,
#3 is Ethical marketing practices. Even if no CL application was ever made since the law was enacted in
2008, according to IPO and Atty. Gepte, it should be in the draft AO because
IPC amendment is the main spirit of RA 9502, not price control/regulation or regulation of pharma marketing.
c. Members of the Council. I am honored that Minimal
Government Thinkers is still granted a slot in the AC despite the fact that MGT
is the smallest unit or institute of all the members. It is not even a
health-focused think tank as its core advocacies are small and limited
government in general, small/few taxes, free trade, rule of law, individual
freedom. Now if there are proposals to remove it from the AC because of this
fact, I will not object, nor will ask who propose it. Not that someone is
proposing this, but am just trying to be consistent. If I have some questions
about the AC or its functions, I am also open to be questioned about my participation
in the AC.
3. Draft AO on Regulating promo and marketing of pharma
and medical devices.
Being a non-lawyer and non-regulator, my patience for long docs like this
18-pages draft AO is short. Personally, I would wish that ALL sectors and
players should have their own respective Code of Ethics or other forms of
self-regulation, with own set of penalties and punishment to erring
members.
How many pharma companies in the PH, how many wholesalers
and drugs import distributors, how many drugstores and pharmacies, how many hospitals
and clinics, how many physicians, nurses, pharmacists, etc.? Tens of thousands
I would assume. The DOH and FDA have the energy, manpower and other resources to
monitor all of them for compliance or
violation? I seriously doubt it.
A better approach is self-regulation, self-policing. Then
DOH and FDA will only monitor those
industry associations, professional organizations, etc. If these civil society organizations do not do their work in
penalizing non-compliant players and professionals, DOH will sanction them and
their officers.
This is a party-spoiler proposal. After so many meetings
and discussions in crafting that document, I will simply propose the above. So I do not expect the above
proposal to be adopted, but only floating the idea, and to ask the various industry and
professional groups to do it on their own, self-policing, parallel with DOH/FDA monitoring
work. Everything is evolving, so that in the future when the finalized AO
will need revision, the various civil society groups have already
done their homework and are more ready for self-regulation.
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See also:
Health Transparency 7: DOH Advisory Council, CHAT, June 04, 2012
Health Transparency 8: Advisory Council on RA 9502, June 11, 2012
Health Transparency 13: MeTA International Visit to Manila, April 16, 2013
Health Transparency 14: IMS-CHAT Meeting, April 18, 2013
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