Module 10: Treatment quality, stigma and discrimination - section 2

In this document:

Obstacles to the provision of HCV treatment and care

Activity: Information with group discussion
Section Time: Approximately 15 minutes

This activity promotes reflection on obstacles to the provision of testing and treatment.

Show Slide 10.5 (Obstacles to the provision of testing and treatment 1) :


To facilitate:

  • Make the distinction between obstacles to ‘provision’ and ‘uptake’
  • Although these sometimes have a common cause, they sometimes point to entirely different targets for action e.g. lobbying decision-makers or ‘Information, Education and Communication (IEC) for the affected population
  • A national or regional ‘Action Plan’ (e.g. those in Australia or Scotland) can be one of the most effective tools for sustaining political commitment and developing services. Is there one that applies to the participants’ setting? If not, this may be a priority for advocacy.

Show Slide 10.6 (Obstacles to the provision of testing and treatment 2) :


Points to emphasise:

  • Briefly explain the role of international IPR legislation as a) creating an environment for companies to invest in R&D and produce new treatments b) maintaining high prices
  • Briefly explain the position of transitional economies (much of E. Europe/Central Asia) as countries without least developed countries (LDCs) patent exceptions and also without the wealth of W. European countries that makes treatment more affordable.
  • Clarify that generic versions of ribavirin are available but none exist for pegylated interferon (making it a target for HCV advocates and their allies).
Supporting content:

It is more complicated to produce cheaper versions of pegylated interferon than ribavirin. For simpler, chemical pharmaceuticals such as ribavirin it is possible to produce ‘generic’, chemically-identical copies. For more complex, protein-based treatments such as pegylated interferon the alternative and potentially cheaper versions are termed ‘biosimilars’ not ‘generics’ which can never be completely identical to the original drug. Consequently, the complexity and cost of developing and obtaining regulatory approval for cheaper alternatives is increased.

 “The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes minimum standards for intellectual property rights and regulations. WTO members are obligated to pass and enforce laws that meet the standards. The TRIPS agreement took effect one year after the WTO was officially founded in January 1995. Its drafting and passage were spearheaded primarily by developed countries keen to more thoroughly codify laws and expectations around the world. Not coincidentally, such countries are home to the vast majority of multinational companies, nearly all of which supported the pact.

Provisions of the TRIPS agreement cover a range of intellectual property issues including copyright, trademarks, and patents. They also specify that disputes between countries over these matters will be subject to WTO dispute-resolution mechanisms and procedures.
The provisions related to patents are the most relevant vis-à-vis medicines and other pharmaceutical products. The agreement aims to globally harmonize patent laws and protections to the fullest extent possible. Under the TRIPS agreement, “governments are required to recognize patents on products and processes in most areas of technology and to confer rights to the patent holder for a given period of time.” To that end, the agreement mandated that the majority of WTO member-states pass laws by 2005 providing patent protection to all new pharmaceuticals for a period of at least 20 years from the date of filing a patent application. That mandate applies to all new pharmaceuticals, regardless of the patent holders’ home country or type of product developed.

Subsequent revisions allowed important and notable exceptions to the 2005 deadline for the world’s poorest nations, which are classified as least developed countries (LDCs) * by the United Nations. LDCs currently have until 2016 to pass and implement patent-protection laws for pharmaceuticals. Until they do so, LDCs need not (under WTO rules) recognize, protect, or enforce patents on pharmaceuticals. (Countries are also permitted to seek extensions beyond 2016.) ”

Access To Essential Medicines Initiative. (2008)

    

*Note: No European or Central Asian countries have LDC status

“The current standard of care for hepatitis C consists of two medicines taken in combination: ribavirin and pegylated interferon. Generic versions of ribavirin are available, but for years pegylated interferon has been available only in two brand-name versions: Pegasys, made by Roche, and Schering-Plough’s PegIntron. The lack of generic alternatives means that a standard 48-week course of treatment for HCV infection can cost more than $20,000 even in resource-constrained countries such as those in Eastern Europe and Central Asia. As a result, most health systems are either unable or refuse to pay for the highest-quality HCV treatment for the majority of patients in need.

Patient advocates and their allies are seeking to overcome this barrier in a number of complementary ways. The main strategy is to encourage and help facilitate production of generic pegylated interferon—preferably more than one version to ensure even greater competition and the lowest possible prices. This strategy ultimately proved successful in regards to HIV drugs. HCV treatment must be approached in the same way: by developing and making available safe, effective, and cheaper generic versions of existing brand-name medicines and increasing research into the creation of new, less expensive therapies.”

Hoover (2009)

Show Slide 10.7 (Obstacles to the provision of testing and treatment 3) :


Points to emphasise :

  • Discuss HCV treatment access with reference to wider aspects of drug users’ exclusion from services
  • Identify ways that drug user, drug treatment status can be used to exclude people from HCV treatment
  • Mention that authoritative guidance on this will be discussed later in the module, not now.
  • Identify the lack of coordination of services within joined up ‘integrated care pathways’ as a different type of obstacle that may respond to different actions.
  • Optionally, refer to tables for country summaries of eligibility/exclusion criteria and provision of services in Merkinaite S and Knerr W (Eds.) (2007) Hepatitis C among injecting drug users in the new EU member states and neighboring countries: situation, guidelines and recommendations. Vilnius: Central and Eastern European Harm Reduction Network (CEEHRN).
Supporting content:

Tables in Merkinaite and Knerr (2007)

  • Table 6: Availability of testing protocols and low threshold testing in the new EU Member States and neighboring countries
  • Table 7: Availability of NEPs and other prevention interventions in communities and prisons in the new EU Member States and neighboring countries
  • Table 8: Availability of OST in communities and prisons in the new EU Member States and neighboring countries
  • Table 9: Availability of HAV and HBV vaccination for PWID in communities and prisons in the new EU Member States and neighboring countries
  • Table 13: HCV treatment guidelines and access to treatment for PWID in the new EU Member States and neighboring countries
  • Table 14: Availability of and reimbursement of HCV diagnostic tests and treatment in the new EU Member States and neighboring countries
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