What are the obstacles to influencing intellectual property policy in healthcare? What are the opportunities?

16 posts / 0 new
Last post
What are the obstacles to influencing intellectual property policy in healthcare? What are the opportunities?

What is holding us back from making the needed changes to intellectual property policy with regard to healthcare?

How does intellectual property affect innovation incentives (both positively and negatively)? What are the trade-offs? Who is protected by intellectual property and who is vulnerable to harm?

Are new spaces for intervention and influence opening up now for activists to activate in the intellectual property and health nexus?  What are those opportunities?

The Promise of Health Care Finance

I teach both IP and Health Care Finance.  For me, the latter course is much more interesting than the former, because initiatives like Medicare Part D in the US leverage (and pay for) more pharma. I just tend to think there is more room for maneuver in health care finance than in IP.  But that's probably only an approach that works in a country that spends as much as the US does.  Still, it seems to me that health licensure laws or other regulations on health could be a point of leverage to force more humane treatment of people.  

I'd be interested to hear

I'd be interested to hear more about the notion of healthcare finance as an alternative approach, as the WHO continues to be engaged in the contentious process of considering alternative forms of funding for R&D, particularly for neglected diseases predominately affected poor populations (with small market incentives for big companies).Though it sounds like it might not apply well to least developed countries.

Intellectual Property Watch also has been looking at the valuation of IP as the concept comes into its own and takes shape, to try to understand its effect on policy debates and I think the public health debate would be a good example.



Another big problem is the undue influence that Big Pharma has over the US Congress. This is one of the reasons why former IP reform activist, writer and academic Lawrence Lessig moved his focus from IP reform to corruption ("not in the sense that representatives are bribed... [but] that the system induces the beneficiaries of Congress’s acts to raise and give money to Congress to induce it to act").  Unfortunately a recent legal challenge that would have limited corporate contributions to political campaigns failed in the Supreme Court, which leaves the possible resolution of this serious problem in limbo.

Free Trade Agreements

This  makes a great deal of sense.  I'd add that there are at least a few champions in the Congress on pharmaceutical issues, but time and again, even when we're trying to find ways to save money for the treasury, representatives will vote for policies that will certainly mean expensive medicines.  There is a slight counterbalance to this as seen in the position taken by Obama and a number of Senators during the healthcare debate on a lower number of years of data exclusivity (I explain this in a different post).  Not that anyone was against data exclusivity which might have been a more logical position in the case of biologics, but still there was a middle road proposed. 

Even more concerning to me is the sway pharma (and other industries) have in international trade policy.  Free Trade Agreements are never free and are less and less about trade.  In essence, countries and industry frequently get together behind close doors to create policy outside of democratic structures.  ACTA is a perfect example of this, where the first request for the text of the document was denied by the US government on national security grounds.  Imagine if that was how we drafted legislation in the US Congress.  The opportunity that this presents is that trade agreements affect a very broad group of stakeholders.  A wonderful Thai activist named Dr. Jiraporn Limpananont for instance has done great work in coordinating various interest groups to act together despite the different focus of the groups.  I fear if we don't focus on trade in the way we did in Seattle with the WTO meetings, we're going to find that we're losing a lot of ground behind closed doors.

Free Trade Agreements & Public Right to Know


Thank you for raising this very important issue concerning the public right to know - as well as the other post regarding Other obstacles to influence that highlighted the conflict of interest aspects presented by large campaign donations by the pharmaceutical industry and their dominate position of influence in crafting legislation that unduly benefits their interests over that of the public's interest and welfare.

Although this example is not specific to health care it is relevant to the aspect of focusing on trade and how they trade agreements are crafted behind closed doors.  I want to share one of the New Tactics tactical notebooks from Canada that highlighted the publics' right to know regarding "free trade agreements".  This tactical notebook is a great read with ideas for those interested in using civil disobedience to move an issue forward:  The Dilemma Demonstration: Using nonviolent civil disobedience to put the government between a rock and a hard place.

Another good resource is

Another good resource is "Intellectual Property in Free Trade Agreements" by Sanya Reid Smith, which is available inexpensively from the Third World Network.  Not sure if it's also online.

EU push for liberal patents and TRIPS plus provisions on Indian

Currently Minister for Commerece in India has denied to give into the pressure from European Union (EU) with regard to TRIPS plus provisions. But that has not stopped European drug companies like Novartis, Roche and others in trying to put pressure on the Prime Minister to bring in TRIPS plus provisions.

One issue that has been aggressively promoted by the EU drug companies on the Indian government is "data exclusivity" and also to increase the patent period duration. Can these issues be tackled by simple dialogue?.

For more information on this issue pl click:-

Dr Gopal Dabade
+91 9448862270

Other obstacles to influence

It's interesting to describe it as obstacles to influence as the topic question does, since it might instead be seen as "obstacles to preventing undue influence" of the most powerful elements of the debate, which I guess would be big pharma, which spent ten times more on lobbying in Washington last year than anyone else. On undue influence, for instance, an item we found on Wikileaks last year and wrote about here http://www.ip-watch.org/weblog/2009/12/09/confidential-documents-release... showed industry with an inside track to influencing the discussions at WHO on R&D financing. Also interesting to think that in other decision-making processes than Congress, any decisionmaker who had received payment from one side of the debate - as campaign contributions could be said to be - would have to declare a conflict of interest. It takes money to buy elections, but it also takes public support, and the alternative to big industry financial support for members of Congress is garnering public opinion. The public generally has a pretty low opinion of the pharma and healthcare industries (despite their life-giving missions) so one must consider what are the channels other than direct financial contributions to elected officials for steering that opinion toward public interest solutions? I guess the media is just one of those ways, but some media are big business (and big IP rightsholders) too....


distilling the message

I think William's post touches on a really important aspect of activism: distilling your message into something that the public at large can grab ahold of.  Both IP and healthcare can be almost Gordian to those who don't deal with those issues on a regular basis.  Doing a better job of "marketing" IP activism causes can certainly go a long way towards helping to steer public opinion toward public interest solutions.  Perhaps one example I would recommend looking to in this area is Creative Commons and the job that they have done in elevating the profile of a very complex issue.  While the actual text of a CC license is just as complicated as any other license, the CC marketing machine has done an excellent job of taking copyright issues and reframing them in a way that those who benefit from the licenses can understand.  Can anyone else think of some examples of good PR?

Here's an interesting article

Here's an interesting article on "the rush for patents choking US stem cell research".



When gov't does not use power they have to improve access to med

Hi everyone,


I have another possible obstacle to add to our list in this discussion thread.  I want to share what happened in South Africa when the Treatment Action Campaign (TAC) decided to change the status quo around access to afforadable HIV/AIDS prescription drugs in South Africa. I'm curious to see if you know of similar examples.

In June 2000, the TAC began importing generic HIV/AIDS drugs in defiance of patent laws to pressure the drug companies to reduce the cost of drugs as well as pressure the South African government to allow the importation of generic versions of patented drugs. 

Fluconazole is an essential drug used to treat HIV-related illnesses.  Like many other anti-HIV/AIDS medications, Fluconazole is produced under patent by a multinational company (Pfizer) and imported into South Africa at a very high price.  Generic versions of the drug are significantly less expensive.

Under earlier TAC insistence, Fluconazole’s manufacturer Pfizer announced it would provide the drug at a reduced price; however, in the months after the agreement it failed to follow through.   TAC’s important efforts pressured the Government to act under South African Patent Act, which gives the government the power to import or produce cheap copies of patented drugs through a humanitarian exemption.

To achieve this exemption, TAC worked with the World Health Organization and Medecins Sans Frontieres to confirm that the imported drugs were safe and effective. TAC arranged systems for purchasing and importing the drugs. 

When the Biozole tablets reached the border, the South African Medicine Control Council
confiscated them while members of that Council debated the issue of granting an exemption for generic Fluconazole. Following pressure from TAC and its international and local supporters, the Council permitted the generic Fluconazole to be distributed to people by one of TAC’s partners. The exemption would be reviewed once the drugs Pfizer promised to deliver to patients in March 2000 actually reached people.  By granting the exemption, the government exercised its discretionary power.

Are there other examples of governments that have the power to open up accessibility to life-saving drugs but simply do not use this power?  Are there examples of governments that have this power and they just don't know it? Do you know of other examples in which the government uses its discretionary power to grant generic-drug exemptions only when pressured by activists?

You can read more about the tactic above here:

Challenging the government to make defiance of pharmaceutical patent laws legal

Opportunities and obstacles

In the US, the government retains "march-in" rights on patents on medicines (and just about everything else) that are discovered with federal funds.  This allows the government to allows others to use the patent in cases where it is not available to the public.  Within the debate on the legislation that put these rights in place, the Bayh-Dole Act, there was a great deal of discuss of this applying to price.  However, despite many requests for the government to use march-in rights in highly abusive situations for exhobitantly priced medicines discovered with public funds, the government has always refused to use these rights.  (I'll add links to further information when my internet connection is better.)  In one case, Fabrazyme, the cost for a patient can be $300,000 per year (the med is needed a persons entire life) and the company manufacturing it has had so many problems making it that newly diagnosed patients can't access the drug while it's rationed for everyone else.

Now the US government is starting a center to take medicines closer to approval to essentially remove the risk for drug companies.  We, the taxpayers, are now officially in the business of drug development.  This means that the rights reserved by the government to protect the public interest are even more important.  If any of the medicines that the government takes fairly far down the development pipeline and then hands off to pharma are exhorbitantly priced the government must demand reasonable prices.  Given that the public interest protections in law are so weak, we likely need stronger protections that require the government to step in to protect the public.

Analogues of this Bayh-Dole Act have been pushed in other countries such as South Africa.  Under the South African version of the law, the process for protecting the public interest is so onerous (a finding of parliament followed by a presidential decree) that it will certainly never be used.

Given the huge amount of money that taxpayers pour into drug discovery and the larger amount they will now spend on drug development, we have a great opportunity to push for better (real) public interest safeguards.

Ethan -- Do you (or anyone

Ethan -- Do you (or anyone else) know much about the IP/access policies of the proposed drug development institute? Is it going to be Bayh-Dole-ish? I need to learn more about what the IP plans are - what should I be reading? I understand this is something that is going to be up and running in October. I imagine this is something UAEM and others would want to influence from the get go.  

TRIPS gives member states the

TRIPS gives member states the choice of whether or not to invoke a compulsory license to manufacture pharmaceuticals and distribute them domestically.  But the 2001 DOHA Declaration also gave member states the ability to import drugs if they did not have the infrastructure to manufacture the drugs domestically.  A number of developed countries have announced that they will not take advantage of this provision and import generic drugs under a compulsive license.  However, there doesn’t seem to have been much use made of the provision by many developing and least developed countries.  I imagine that domestic laws for the exporting countries would be another barrier for LDCs, so what can be done to allow members to take full advantage of provisions that are required under TRIPS?  Why allow all of these efforts to be made in order to make technology more accessible if no one will ever be able to benefit from their existence?

Unable to take advantage of the Doha Declaration

The Doha Declaration sounded promising however since then developed countries and Bigpharma have failed again and again to uphold the Declaration, bullying LDC's into not taking advantage of the Doha Declaration. One of the newest examples of not upholding these provisions was brought up earlier in the thread – the EU-India Free Trade Agreement. This sought to introduce data exclusivity, preventing generic drug companies from producing drugs without running its only lengthy and expensive trials (i.e. in effect preventing its production, or delaying it at best).  With India being the pharmacy of the developing world it is essential that the generic drugs made in India continue to be made. Without this the effects would be much further afield than just India as so many countries do not have the infrastructure to support they’re own generic companies. MSF buys 80% of its AIDS medicine from India, with this source dried up, where will they go? The result? - Unnecessary deaths all over the developing world.

The European Commission has been involved in impeding access to medicines in other ways, for example seizures of medicines in European ports. One specific episode was a shipment of losartan potassium (a blood pressure drug ingredient) was seized on its way from India to Brazil. It is not patented in India or Brazil however due to the patent protection in the Netherlands the shipment was sent back to India.

Kantin asked about governments who have the power to open up accessibility to life saving drugs. It has been tried in many places and Bigpharma rarely fails to retaliate with a lawsuit.

In January 2001 Thailand entered price negotiations with Abbot with regards to antiretroviral medication. When these failed to deliver Thailand resorted to compulsory licensing of a generic version of the drug. This action being completely within it’s rights; the WTO's Doha Declaration explicitly says, "Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted." Abbott retaliated by withdrawing seven new drugs from the country. The Doha Declaration Provisions are all very well and good but they are useless if a country can be penalized for using them.

Topic locked