[Ip-health] WHO – Governmental pushback on industry role in medical product regulation

alexandra bhattacharya alexandra.bhattacharya at gmail.com
Fri Jun 6 00:15:43 PDT 2014


*Title :* TWN IP Info: WHO – Governmental pushback on industry role in
medical product regulation
*Date :* 30 May 2014

*Contents:*

TWN Info Service on Intellectual Property Issues (May14/13)
30 May 2014
Third World Network
www.twn.my

*WHO: Governmental pushback on industry role in medical product regulation*

Geneva, 30 May (K M Gopakumar) – Pharmaceutical influence over medical
product regulation at the World Health Organization has been pushed back by
governments.

The 67th World Health Assembly (WHA) that took place on 19 – 24 May adopted
the resolution on regulatory system strengthening for medical products
after dropping reference to regulatory harmonisation and the International
Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). Set up in 1990, the ICH brings
together the regulatory authorities and pharmaceutical industry of Europe,
Japan and the US “to discuss scientific and technical aspects of drug
registration”. Its critics note that the ICH in effect is a mechanism for
the pharmaceutical industry to influence, even set, standards.
"Harmonization" in this context is a code word for industry-led standards
setting which favours the interests of pharmaceutical transnational
corporations in order to prevent generic medicines competition.

The resolution was proposed at the 134th meeting of WHO Executive Board,
which took place 20-25 January 2014 in Geneva. See
http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_R17-en.pdf
It was a follow up to the WHO Secretariat report on regulatory system
strengthening. See
http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_32-en.pdf

There was no consensus at the Executive Board due to concerns from some
developing countries and the draft resolution was forwarded with bracketed
text to the WHA for health ministers to resolve.

Developing countries such as India and China continued to express concern
at the WHA on harmonisation and reference to the ICH. India stated that
their support for the resolution is based on a common understanding that
the development of norms, standards or guidelines as per WHO principles,
are free from conflict of interest and excludes the influence from any
initiative driven by industry. China stressed national autonomy and
independence in regulatory cooperation, and that harmonization should be on
a voluntary basis.

The removal of the words “harmonization and convergence” from the text of
the resolution that was finally adopted clearly shows that there is a
consensus among Member States to accept the concerns over regulatory
harmonization. Secondly, Member States clearly expressed concerns with
regard to the involvement of industry in the WHO’s regulatory norms and
standard setting.

The draft resolution that was brought to the WHA from the Executive Board,
in Operational Paragraph 1(f), urged Member States to “implement relevant
guidance and science-based outputs of international regulatory
harmonization and convergence efforts such as, where applicable, the
Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use.”

It further urged Member States to promote international cooperation to
promote “convergence” (an indirect reference to harmonisation) in
Operational Paragraph 1(3).

In Operational Paragraph 2(1) the resolution requested the WHO Director
General to develop appropriate norms and standards, “taking into account
the standards created by existing regional and international initiatives”.
Further, it also asked the WHO DG to promote the greater participation of
Member States in existing international and regional initiatives for
collaboration, harmonization and convergence in accordance with WHO
principles and guidelines.

Four days of informal negotiations at the recently concluded WHA led to the
finalisation of the resolution.

The resolution is believed to be an effort to further Global Medicines
Regulatory Harmonisation (GMRH), an initiative by the World Bank.  The
World Bank is administering a multi-donor trust fund, which was established
in 2011 with an initial contribution of USD 12.5 million from the Bill &
Melinda Gates Foundation (Gates Foundation).

According to the annual report of GMRH published in 2013 the origins of the
initiative goes back to 2009.  According to this annual report “In 2009, a
consortium of partners including the Pan African Parliament, NEPAD Agency,
the World Health Organization, Bill & Melinda Gates Foundation, UK
Department for International Development, and the Clinton Health Access
Initiative came together to establish the African Medicines Regulatory
Harmonization (AMRH) Program”.  With the help of Gates Foundation funding
“it possible for the World Bank to set up GMRH to implement AMRH and to
scale up medicines regulatory harmonization activities in Africa and
beyond.”

The US Food and Drug Administration (USFDA) and International Conference on
Harmonisation of Technical Requirements are believed to be important
partners. See
http://www.who.int/medicines/areas/policy/IPC_dec2012_Seiter_reg.pdf

ICH plays an important role in the harmonisation process to determine the
common minimum standards for medicines registration.  ICH incorporated many
of the harmonisation initiatives as part of its Global Co-operation Group
(GCC). Six Regional Harmonization Initiatives of namely the Asia Pacific
Economic Community, Association of South-east Asia Nations, East African
Community, Pan American Network for Drug Regulatory Harmonization, Gulf
Cooperation Council and the Southern African Development Community are part
of ICH’s GCC along with other eight Drug Regulatory Authorities/Department
of Health namely Australia, Brazil, China, Chinese Taipei, India, Republic
of Korea, Russia and Singapore.

According to a paper by Aylet Berman, a researcher who has worked
extensively on the ICH, the ICH standards “have been to the detriment of
entities, companies and countries that lack sufficient resources, and have
advantaged resourceful companies and countries. In practice, this means
that they have benefited larger, privately held, export-oriented companies,
and have been to the detriment of smaller, locally oriented, or
governmentally funded companies/entities”.

She further states “in certain contexts, they have promoted the commercial
interests of the multinational pharmaceutical industry over the interests
of patients in receiving much needed medicines or treatments”.  According
to her “the members are the main beneficiaries, non-members have been
subject to distributional effects that are to their detriment”.

WHO’s involvement in ICH activities raises serious concerns on conflict of
interest with regard to WHO’s role in the norms and standard setting
related to medicines (See TWN Info Service mailing dated 19 May 2014: “WHO
alliance with industry raises concerns over medicine regulation”.)

The adopted resolution amended the preamble paragraph of the version from
the Executive Board that contained a reference to ICH. The preamble
originally stated: “Also noting with appreciation the ongoing collaboration
between some national regulatory authorities, including at the global
level, in setting standards, including the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals
for Human Use among others, and encouraging a continued emphasis of effort
in strengthening regulatory systems in accordance with WHO principles and
guidelines”.  The amended preamble reads” “noting the ongoing collaboration
between national and regional promoting cooperation among authorities at
the regional  and  global level”.

Operational Paragraph 1 (f) was also amended, which originally urges Member
States to strengthen national regulatory systems by, as appropriate,
“implementing relevant guidance and science-based outputs of international
regulatory harmonization and convergence efforts such as, where applicable,
the Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use”.

The resolution dropped the words “regulatory harmonization and convergence
efforts such as, where applicable, the Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use
the reference to harmonisation”. The amended text urges Member States to
strengthen national regulatory systems, including through, as appropriate
and voluntarily by “facilitating the use of relevant guidelines and science
based outputs of WHO Expert Committee and good regulatory practices at the
national, regional and international level”.

Similarly the word “convergence” was removed from Operational Paragraph 9
of the Executive Board version that originally stated: “to identify the
need to strengthen regulatory system capacity, collaboration and
convergence in the technically complex areas where substantial gaps may
still exist, such as the regulation of biotherapeutic products, blood
products, and in vitro diagnostics”.  This is now renumbered in the final
resolution as paragraph 10 without the word “convergence”.

In paragraph 2(1) the indirect reference to ICH has been removed. The
earlier draft requested the WHO DG to continue to support countries in the
area of regulatory system strengthening, including by developing
appropriate norms and standards taking into account the standards created
by existing regional and international initiatives …” This is now reflected
as new text in Operational Paragraph 2 (2) that states: “to continue to
develop appropriate norms, standards and guidelines, including taking into
account national, regional and international needs and initiatives in
accordance with WHO principles”.

The words “harmonisation and convergence” were removed from the draft
paragraph 2(4) which originally stated: “to promote the greater
participation of Member States in existing international and regional
initiatives for collaboration, harmonization and convergence in accordance
with WHO principles and guidelines”. The amended text now placed as
paragraph 2(5) states: “to promote the greater participation of Member
States in existing international and regional initiatives for
collaboration, cooperation in accordance with WHO principles and
guidelines”.

Similarly, paragraph 2(6) of the Executive Board version was also amended,
removing the words “harmonisation and convergence”. The draft text read:
“to increase support for and recognition of the significant role of the
International Conference of Drug Regulatory Authorities in promoting the
exchange of information and collaborative approaches among drug regulatory
authorities, and as a resource to guide and facilitate further development
of, and regulatory harmonization and convergence among, these authorities …”

The amended version clearly states “to increase support for and recognition
of the significant role of the International Conference of Drug Regulatory
Authorities in promoting the exchange of information and collaborative
approaches among drug regulatory authorities, and as a resource to
facilitate further development of, regulatory cooperation and coherence”.

Even though the resolution removed the reference to ICH and harmonization,
we have yet to see whether the WHO Secretariat will bring any concrete
changes in its approach to regulatory harmonization, taking into
consideration the concerns expressed by Member States including India and
China.

Skeptics are of the view that without constant monitoring by Member States
the Secretariat is not going to change its approach. Even though the
Assistant Direct General in charge of medical product regulation stated in
a side event that the focus is on convergence and not in harmonization,
observers point out that it is different words with the same meaning.

Concerned observers cite the Secretariat report to the WHA on RSS which
clearly advocates regulatory harmonization.  It states “In order to improve
the regulation of medical products globally and ensure that the medical
products that patients use are of assured quality, more emphasis needs to
be placed on regulatory convergence and harmonization, which offers
numerous benefits to both regulatory authorities and the pharmaceutical
industry, and which has a positive impact for the protection of public
health. Stimulating and/or initiating collaboration between regulators from
various countries on regulatory activities based on converging and
harmonized technical standards is becoming more and more important”.

Another reason for the Secretariat’s reluctance to move away from the
harmonisation is emanating from WHO’s involvement in various harmonisation
initiatives including at the international level (ICH and GMRH) and the
regional initiatives like the Pan American Network for Drug Regulatory
Harmonization  and African Medicines Regulatory Harmonization Initiative.

Further, some observers also point out to the fact that even though the
words harmonization, convergence and ICH have been removed from the
resolution, there are still indirect references to ICH and harmonization
efforts. This may be used by the Secretariat to justify its current
engagement with ICH and other harmonization initiatives that may be
problematic.

For instance paragraph 1(f) asks countries to facilitate, as appropriate
and voluntarily, the use of relevant guidance of WHO experts committees
along with good practices at the national, regional and international
level. The words “international level” may be used to justify the ongoing
engagement with ICH and other harmonization initiatives. Similarly,
paragraph 2 (2) requests the DG while developing appropriate norms
standards and guidelines to take into account international needs and
initiatives in accordance with WHO principles. Again the Secretariat can
justify its current approach citing the mandate under this paragraph which
allows the DG to take into account international initiatives.

Yet again, paragraph 2(5) requests the DG to promote greater participation
of Member States in the existing regional or international initiatives.
Does this mean that WHO promotes the participation of Member States in
various medical product regulatory harmonization initiatives, including the
World Bank’s Global Medicines Regulatory Harmonisation?

However, it may not be so easy for the Secretariat to push for
harmonization and to continue its current level of engagement with ICH.
Operational paragraph 2(2) does not provide a blanket mandate to the
Secretariat to engage with ALL international initiatives. The DG is to
ensure that while taking into account of international initiatives it
should be in accordance with WHO principles. As per the established WHO
principles there should not be any engagement with industry in norms and
standard setting. The ICH engagement is widely seen as in conflict with WHO
principles due to a conflict of interest between industry and the WHO.

Member States who are concerned about the Secretariat’s activities in the
area of regulatory system strengthening also have the opportunity of “gate
keeping” to a certain extent through the Member State Mechanism.
Operational Paragraph 2 (11) of the resolution requests the DG “to ensure
that any activities carried out under this resolution does not duplicate or
circumvent the work plan and mandate of the Member States Mechanism on
SSFFC Medical products”.  The Member State Mechanism identified
strengthening of drug regulatory authorities as a priority in its work plan.

(SSFFC means “Substandard/spurious/falsely-labelled/falsified/ counterfeit
medical products” in WHO parlance.)

The removal of the words “harmonization and convergence” from the
resolution clearly reflects the consensus among Member States to accept the
concerns over regulatory harmonization and the ICH as well as over the
involvement of industry in WHO’s regulatory norms and standard setting.
The translation of the resolution into action now depends on the constant
vigilance of the Member States.

Further, the resolution also amended Operational Paragraph 1(8) which deals
with prequalification of medical products. Prequalification is an
evaluation of the WHO to assess the quality of medical products to
facilitate the procurement of these products by international agencies such
as UNICEF and the Global Fund for the treatment of HIV/AIDS, TB and
Malaria. The Executive Board draft resolution stated: “to support WHO in
its efforts to strengthen its prequalification programmes, including
exploring modalities in consultation with Member States for improved
sustainability of this critical programme, while also focusing on
supporting national and regional initiatives to improve regulatory capacity
for medical products focusing on achieving longer term objectives of
developing national regulatory authority capacity among Member States.”
This is now split into two separate operational paragraphs.

Operational Paragraph 8 now reads: “National and regional initiatives of
regulatory authorities to improve regulatory capacities for review of
medical products and to promote WHO’s long term objective of supporting the
strengthening of national regulatory authority capacity among Member
States.”

An additional Operational Paragraph 9 was added, which states: “to support
WHO’s prequalification programmes, including exploring modalities in
consultation with Member States for improved sustainability of these
critical programmes”.

Similarly, Operational Paragraph 5 of the Executive Board version is
amended to strengthen the integration and coherence among WHO’s
prequalification programmes as an aid to assuring safe supply of quality
medical products, engaging with Member States in the further refinement and
improvement of the global prequalification model, while in parallel
supporting the development of functional national and regional regulatory
bodies and networks, leading to more global participation in the global
prequalification programme.

The amended paragraph 5 is renumbered as Operational Paragraph 6 which
states: “WHO’s prequalification including their integration and coherence,
taking into account the needs and capacities of national and regional
regulatory systems to assist in ensuring a supply of quality, safe,
efficacious  and affordable  medical products.”

There are concerns with regard to strengthening and mainstreaming of WHO
prequalification programmes without a complementing international
procurement mechanism. In the absence of an international procurement
mechanism, such mainstreaming of WHO’s prequalification as the stamp for
quality assurance would affect local production initiatives and reduces the
competition from generic producers. The resolution has thus put speed
breakers in mainstreaming of WHO’s prequalification mechanism to assess the
quality, safety and efficacy of medical products.

Finally one of the important weaknesses in the resolution is that it
focuses only on one aspect of regulation and it is silent on other aspects
the regulation viz. controlling the promotion and advertising of medical
products; monitoring adverse reactions to medicines and medical products;
providing independent information on medicines to professionals and the
public. Even though the Secretariat’s report on regulatory system
strengthening lists the above aspects as part of the regulatory mechanism,
the resolution failed to include them. Similarly, it is also silent on the
promotion of rational use of medicines. Thus the narrow focus on only
certain aspects of regulation of medical products results in the lack of a
holistic approach on regulation.+

(Note: This is an expanded version of the article first published in
*south-north
development monitor SUNS #7814.*)



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