National Blood Authority Australia – Annual Report 2008–2009

3.4 The Regulatory Environment

In addition to the continual upgrade of manufacturing requirements and standards that affect the sector, several company decisions were of note during 2008–09:

• In the United States Roche is reported to have resigned from the Pharmaceutical Research and Manufacturers Association and signed up to the biotechnology regulator, the Biotech Industry Organisation.
• In the United Kingdom Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry, putting a question mark over the viability of self-regulation in the United Kingdom.
  • While the Medicines and Healthcare Products Regulatory Agency possesses the legal power to take pharmaceutical groups to court for any wrongdoing, it is generally the Association’s Prescription Medicines Code of Practice Authority that deals out penalties to its member companies.
  • Roche had its membership suspended for six months until February 2009 for breaching the Association’s Code of Practice. The company says its time away from the Association gave it the opportunity to ‘reflect upon the nature’ of its relationship with the trade body. Roche says it remains committed to working within the bounds of the Association’s Code of Practice.
• the US Federal Trade Commission released a report, entitled Follow-on biologic drug competition, that examines whether the price of products manufactured using living tissues and micro-organisms could be reduced by competition from so-called follow-on biologics, having a price impact similar to that of generic drugs. No pathway currently exists for follow-on-biologics to enter the market and compete with their pioneer counterparts. The Commission’s report concludes that giving the Food and Drug Administration the authority to approve follow-on-biologics would be an efficient way to bring these lower priced drugs to market.

Case Study
The Collaboration of National Plasma
Product Supply Planners

In early 2008, after informal discussions between several representatives of national agencies, an idea developed to establish an informal collaboration of national agencies that have oversight responsibility for plasma products, particularly from an appropriate use, purchasing and/or supply planning perspective.

In June 2008 a few interested agencies took the opportunity to hold scoping meetings in the margins of international conferences, and the idea quickly developed into the Collaboration of National Plasma Product Supply Planners, or NPPSpa. In order to progress the group, the NBA undertook the role of secretariat to coordinate the inaugural meeting, to be held in Paris during March 2009.

The NBA’s General Manager chaired the inaugural meeting, which was attended by representatives of member agencies—from Canada, Finland, Italy, New Zealand and Australia. The agenda included confirmation of the terms of reference, a brief presentation by each member outlining their agency’s role, and extensive opportunity for members to discuss topics of interest—including self-sufficiency, the fate of surplus products, trends and issues in IVIg use, and approaches to new product listing. In addition, several invited suppliers made presentations to members on the topic of ‘Innovation in process technologies‘. The 2010 meeting will be hosted by Italy, with the NBA providing both the chair and secretariat support.

One of the key capabilities of the NBA is the expertise gained through good international networks that provide information about what similar organisations are doing overseas. We hope that other national agencies facing similar challenges will consider participating in NPPSpa: it is proving to be an excellent and cost-effective way of learning about the latest thinking in organisations with similar mandates.