Source: Times of India
2 Sep 2014
NEW DELHI: Civil society groups working to improve access to medicines have protested against the participation of NGOs, especially patients’ groups receiving substantial funding from pharmaceutical companies, in the meeting on quality and safety of biosimilars which was held before the International Conference of Drug Regulatory Authorities (ICDRA) in Rio, Brazil.
Biosimilars is a biological medicine that is similar to another biological medicine that has already been authorized for use. The regulation of biotherapeutic products particularly biocompetitors and its impact on access to affordable safe and efficacious biotherapeutics has been a subject of controversy as pharma multinationals holding patents on an original biological medicine have been arguing that biosimilars by definition are not likely to be identical to the originator biologic.
However, civil society groups working on increasing access to medicines have argued that pharma companies were using this argument to keep out cheaper copies of biologics which are going off patent from coming to the market. These groups pointed out that the main reason for biotherapeutics being exorbitantly prices was the high degree of entry barriers, which favoured the commercial interests of the originator pharmaceutical industry and eliminated effective competition aimed at driving down the price. While the ICDRA conference is restricted to government officials and drug regulatory authorities of WHO member states, the pre-conference meeting on biosimilars taking place at the same location was open to industry to engage in a discussion on biosimilars.
Some of the patient groups who were part of the pre-conference meeting were ABRALE – the Brazilian Association of Lymphoma and Leukemia, founded in 2002 by a group of patients and families, International Alliance of Patient Organisations (IAPO) and Alliance for Safe Biologics comprising diverse healthcare groups and individuals, from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines. All three receive significant funding from multinational companies including GSK, Medtronic Foundation, Johnson & Johnson, Merck, Novartis, Pfizer and so on.
In a position paper on patients’ groups and industry funding titled “Unhealthy Influence” brought out by Health Action International (HAI) Europe, a non-profit which campaigns for access to and rational use of medicines, HAI pointed out that patients’ groups like IAPO offered pharmaceutical industry credibility by taking positions that were harder to refute coming from a patients’ organization than from a company. It further stated that often such patients’ groups refrained from criticizing the industry even when they acted against the interest of the patients the group claimed to represent. HAI also talked about the difficulty in assessing pharma influence on patients’ groups due to widespread failure to publish accounting/financial data of these groups.
On patients’ groups at the pre-ICDRA meeting, Marcela Vieira of ABIA (Brazilian Interdisciplinary Aids Association ) said, “Unfortunaly all NGOs that were invited by the organizers to speak at the Pre-ICDRA are heavily funded by the big pharma. ABRALE receives more than half of its annual budged from multinational pharmaceutical companies. That raises questions about which interests they are actually defending, if it is the best interest of the patients or the commercial interests of their funders.” She went on to to say that in topics such as intellectual property, which is a known barrier to access to medicine, it was very difficult for access-to-treatment activists to see a patient group calling for greater protection of intellectual property of biotherapeutics, as ABRALE did in their intervetion at Pre-ICDRA.
K M Gopakumar of Third World Network, a non-profit international network of organizations and individuals involved in issues on development and the Third World also participated in the pre-ICDRA meeting. Gopakumar said that it was unfortunate that Pre-ICDRA conference speaking slot were given to only those NGOs, which are receiving funds form pharmaceutical transnational corporations. “This gives an opportunity for pharma to convey the message suitable to the industry interest as NGO’s voice. In this case, the message was often conveyed as messages from patient’s groups. WHO should not facilitate the backdoor entry of pharma voices through pharma funded NGO. WHO should respect genuine civil society voices,” said Gopakumar.
The ICDRA conference ended on Friday with the civil society groups issuing a statement seeking the intervention of the WHO and member states to ensure a regulatory framework which facilitated effective competition in the biotherapeutic market instead of making the regulation an unnecessary technical barrier itself.