We, the undersigned organizations, bring to the attention of Drug Regulatory Authorities, WHO, Member States and other participants of Pre and International Conference on Drug Regulatory Authorities (Pre-ICDRA and ICDRA) and community in general the following concerns with regard to the regulation of biotherapeutic products, particularly biocompetitors, and its impact on access to affordable, safe and efficacious biotherapeutics.

1. The access to biotherapeutics can play an important role in the fulfilment of the human Right to Health and peoples’ right to enjoy the benefits of scientific progress and its applications. While, recognizing the potential of biotherapeutic products in addressing critical health care needs, due to its recent introduction in to the market, the therapeutic
efficacy and safety of many of them are yet to be fully established.

2. The exorbitant price of biotherapeutic products places them beyond the reach of millions of people who need them. In addition, exorbitant price also makes it impossible for governments to include biotherapeutic products in the public health program in a sustainable manner and without compromising the allocation of funds intended for other equally important health services and technologies.

3. There is an increasing push from healthcare industry to promote biotherapeutic products. In 2007 the global market of biotherapeutics was around 100 billion USD. In 2012 it surpassed 170 billion and it is expected to reach 250 billion USD by 2020. The promotion of biotherapeutic should not be driven by market interests, but by the actual health needs of populations.

4. The main reason for the exorbitant price is the high degree of entry barriers, which favors the commercial interests of the originator pharmaceutical industry and eliminates effective competition aimed at driving down the price. Generally speaking, there are two levels of barriers around biotherapeutic products that reduce access: i) intellectual
property rights (patent and trade secret) and ii) unnecessarily stringent regulatory framework. Since the patent protection on many biotherapeutic products is about to expire, originator companies (mainly pharmaceutical transnational corporations – TNCs) are making huge effort to build unnecessary regulatory wall to prevent competition. This compromises the access to biotherapeutics products and the possibilities and feasibility of
enhancing and strengthening national manufacturing capabilities.

5. The current WHO guidelines are based on the ICH standards, an exclusive club of originator companies and drug regulatory authorities of US, EU and Japan, for the regulation of biosimilar medicines. The WHO Guideline creates an entry barrier by insisting on comparative exercises and/or studies with the originator product as a precondition to approve a biotherapeutic products/biosimilar. This compromises access to affordable biotherapeutic products as in the case of mainstream pharmaceutical
products (small molecules) by curbing the possibility of effective competition.

6. In the light of historic evidence on these medicines, accumulated scientific and regulatory experience we call upon Governments and Regulatory Authorities to establish regulatory frameworks that facilitate access to affordable, safe and efficacious biotherapeutic products.  In other words the regulation cannot pose a new barrier to competition and access to affordable biotherapeutic products. Quality is not an end in
itself and the regulation becomes meaningless to people if it impedes access to affordable medicines.

7. In this regard we draw the attention of Pre-ICDRA and ICDRA participants to the World Health Assembly Resolution on access to biotherapeutic products, adopted in May 2014 (WHA 67.21). The resolution urges Member States “to work to ensure that the introduction of new national regulations, where appropriate, does not constitute a barrier to access to quality safe, efficacious and affordable biotherapeutic products, including
similar biotherapeutic products”. And also requested WHO Director General to update the 2009 WHO Guideline taking into account the technological advances for the characterization of biotherapeutic products and considering national regulatory needs and capacities.

8. We congratulate the initiative of the Government of Colombia and other Governments to make use of an abbreviated regulatory pathway for the approval of biotherapeutics/biosimilar that prioritize public health needs.

We urge the Colombian Government to resist the pressure from pharmaceutical TNCs and their home governments like USA and to implement abbreviated pathway at the earliest.

9. Further we also note that there is an attempt to devise different International non-proprietary names (INN) system for biologics, which would give different INNs to follow-on biotherapeutic products (generic). This would seriously affect the possibility of inter-changeability and limit the access and competition.

Against this background we call upon the Regulatory Authorities, WHO and
Member States:

·       To ensure enjoyment of right to health and right to enjoy the progress of science and technology through appropriate regulation of biotherapeutics and do not view regulation as an end in itself
·       To implement the directions provided in the WHA 67.21

·       To develop an appropriate regulatory framework for biotherapeutic products that ensure universal access to affordable, safe and efficacious biotherapeutic products.

·       To ensure a regulatory framework which facilitate effective competition in the biotherapeutic market instead of making the regulation an unnecessary technical barrier itself.

·       To review WHO Guidelines on biotherapeutic products/medicine based on the accumulated scientific and technology advancement, in a transparent manner with utmost care for avoidance of conflict of interest and including representative Governments in the setting and discussion process.

·       To stop attempts for the creation of separate INN regime for biotherapeutic products/medicine.

·       To insist for the full disclosure of data and relevant information on clinical trials and manufacturing process by the originator companies.

·       To make sure that regulatory framework is guided by public health needs and to move away from the corporate driven regulatory norms and setting process.


ABIA – Associação Brasileira Interdisciplinar de Aids (Brazil)

Alianza LAC – Global por el Acceso a Medicamentos

All India Drug Action Network (AIDAN) (India)

Centro de Información de Medicamentos de la Universidad Nacional de
Colombia (CIMUN) (Colombia)

Colegio Nacional de Químicos Farmacéuticos de Colombia (Colombia)

Comité para la Veerduria Cuidadana en Salud – CVCSs (Colombia)

Federación Médica Colombiana (Colombia)

Fundación GEP (Argentina)

Fundación IFARMA (Colombia)

Health Action International (HAI)

Misión Salud (Colombia)

Observatorio del Medicamento de la Federación Médica Colombiana –
Observamed (Colombia)

REDLAM – Red Latinoamericana por el Acceso a Medicamentos

Peoples’ Health Movement (PHM)

Third World Network (TWN)

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