Liveblog: TACD IP: Innovation and Access for Medical Technologies

The next panel is on Innovation and Access for Medical Technologies. First is Anthony So of Duke University.

• Perfect storm in pharma industry: lower productivity of R&D pipeline, increased generic competition, VC funding drying up
• Clinical trials as a public good: non-transparent trial results (selective disclosure); avoidance of clinical trials that might reveal unfavorable outcomes (head-to-head effectiveness not compared); data exclusivity; shelved products
• Public funding for trials = less need to recoup costs with high prices
• Opportunity: Call for comparative effectiveness clinical trials; call for economic recovery package
• Implementation issues: Start with revenue-neutral strategy with targets of opportunity (e.g. comparative effectiveness trials); strategic support for alternative business models for neglected diseases; must not have conflicts of interest
• Recommendations: Public access to full clinical trial protocols and regulatory submissions; establish an independent entity to conduct clinical trials in the public interest; offer funding incentives for alternative business models to lower the costs of drug development

Questions:
[I asked about the FDA Amendments Act and clinicaltrials.gov, as well as the U.S. withdrawing support for the Declaration of Helsinki.]

Jamie Love asked a question but I was too busy Googling the above to pay attention.

Q: Is there a standard model for drug development that takes these concerns into account?
There are common elements: royalty-free access to developing countries, establishing the conditions up front from funding.

Next is Sophie Bloemen of Health Action International.

• Recommendation: Apply competition policy more strictly in the area of pharmaceuticals.
• Recommendation: Move regulatory authority from the European Commission’s Directorate General of Enterprise and Industry to DG of Health and Consumers.
• Recommendation: Re-assess IP policy toward developing countries. No correlation between EU position at WHO IGWG and in bilateral trade agreements.

Next is Ellen ‘t Hoen, formerly of MSF and futurely of UNITAID:

• Use of Doha flexibilities is widespread
• But older (generic) ARVs are much cheaper than newer second-line ARVs
• UNITAID is a multilateral funding mechanism for AIDS, TB, and malaria drugs. Explicitly supports Doha principles and other innovative mechanisms.
• Patent pool [voluntary collective license]. Supported in WHO global strategy on IP, UNITAID commitment, NGO support, response from patented and generic manufacturers positive
• Recommendations: Support UNITAID initiative to set up a patent pool for LMI countries. Support i+a agenda: implement WHO IP global strategy, WHA resolution 60.30. Obama should tell WHO DG to release Bolivia/Barbados proposal.

Next is Judit Rius of Knowledge Ecology International:

• Recognize the Doha Declaration, honoring the public health flexibilities in IP rules. Countries have the right to do this, but US and Europe are threatening when they do so. Don’t negotiate for TRIPS+ provisions like data exclusivity.
• Mandate open licensing of public funded R&D to developing countries.
• Promote R&D incentives that separate innovation from market for the product, e.g. prize funds
• Inducements should include open source dividends to encourage open sharing of knowledge, data, material, and technology
• Support a biomedical R&D treaty (WHA 61.21) — sustainable financing for needs-based R&D, open access to scientific articles and data from publicly-funded research

Next is Rob Weissman of Essential Action

• Renegotiate bilateral FTAs: Eliminate TRIPS-plus measures (minimum: renegotiate to revise patent rules to match changes in Peru/Panama), abandon anti-counterfeiting agenda for medicines (including ACTA)
• Climate change technologies: no pressure on countries for using TRIPS flexibilities regarding climate change technologies; publicly funding technologies openly licensed to developing countries
• Biogenerics: biologics are much more expensive than conventional drugs; no process for generic approval. Issues:
  • Regulatory pathway
  • Data exclusivity (submitted regulatory data — generics point to data submitted previously; exclusivity means they can’t use that data and have to re-do the tests at high expense) — recommendation: no exclusivity (alternative: cost-sharing, generics pay a share of the disclosed costs of trials)
  • Patent-related issues: how do you figure out which patents apply to a drug (patents listed in Orange Book), how do you resolve patent disputes before a patent expires — recommendation: disclose patents as a condition of enforceability, no delay for when generics can challenge a patent (industry wants a delay), no requirement for generics to share confidential information with patent holder (industry wants to require disclosure so they can assess potential infringement).
• Consequences: could have massive savings with an efficient generic approval system. Affordability depends on an effective generic market

Questions:
Love: How does biogenerics track in Europe?
Weissman: I don’t know.
Sarah Rimmington of Essential Action: Europeans have higher data exclusivity than 5 years under Hatch-Waxman. Why shouldn’t we have higher levels like Europe? Well, Europeans have price controls.
Weissman: Should they be called biogenerics or biosimilars? Question is whether they’re substitutes or in the same class.

Love: If WHO begins discussion on an R&D treaty, what advice would you give negotiators on what to include?
Rohit Malpani of Oxfam: Have to clarify funding levels.
‘t Hoen: Principle is that everyone contributes to the R&D. Priority-setting is important: how do you identify needs.
Weissman: Still being able to have a patent system for drugs makes the R&D treaty more politically feasible.
Rius: Negotiation needs is start. Prioritization is important. How to fund it is important — not high prices. Who pays for it — must include middle-income and some low-income countries.

Aigrain: Do you plan a campaign to move authority to SANCO?
Bloemen: Yes, we are planning to campaign on it.

Q: Does the fact that citizens in Europe and U.S. will have crisis with access to medicines will change the way they see it? Do we have something to learn from developing countries?
Weissman: Reality is industry vs. consumers (governments, employers). Pricing fights: biogenerics, Medicare compensation for publicly-funded drugs, reimportation.
‘t Hoen: Pricing crisis will offer opportunity — more people will get involved, offer ideas.

Malpani: Advance market commitment, priority review voucher: Comments?
Rius: They’re good — consequence of IGWG. But implementations are just at the service of the current business model. But doesn’t de-link from monopoly rights. Need i+a.
‘t Hoen: Companies have scooped up extra subsidies through this. AMC goes to a pre-existing product and doesn’t change the IP. Priority review is difficult: speeding up health review is not in the interest of health consumers. But encouraging to have new proposals and to test them. But we need to assess them critically.

[end of conference. I'll post the notes from this morning later, as well as my missing-but-now-recovered post from yesterday.]