[Ip-health] ​KEI submission to OECD consultation on "Sustainable access to innovative therapies"

Andrea Carolina Reyes Rojas subdireccion at mision-salud.org
Thu May 11 10:22:27 PDT 2017

Thank you dear Jamie

Please find in this link 
and below the submission to OECD of Misión Salud, Ifarma foundation, the 
Medicines Information Center of the National University of Colombia 

We focused on promoting the use of public health safeguards and a call 
to OECD countries to implement the recommendations made by the UNHLP.

Reflecting on the last 5-10 years, what do you think have been the major 
changes affecting access to medicines?

Despite immense scientific advances that lead to innovative therapies, 
States have not been able to guarantee access to medicines for all, 
either because there do not exist health technologies to cure, treat or 
diagnose health conditions that affect disproportionately poor people 
(regardless of the country they live in) or because health technologies 
do exist but are excessively expensive.

One of the main reasons behind this situation is that the current model 
to promote research and development (R&D) of health technologies is 
based on the expectation of pharmaceutical companies of high returns 
through high-pricing their products. Pricing has been unlike 
manufacturing costs, resulting in abuses of the monopoly guaranteed by 
means of intellectual property protection such as patents and test data 

This model was established worldwide through the WTO Agreement on 
Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994, 
and in 2001, the Doha Declaration on the Trips Agreement and Public 
Health recognized the barriers to access to medicines that result of the 
TRIPS innovation model, and therefore, it also highlighted the 
importance of TRIPS-public health safeguards. Indeed, it states, “we 
reaffirm the right of WTO members to use, to the full, the provisions in 
the TRIPS Agreement, which provide flexibility for this purpose (promote 
access to medicines for all)”.

Despite the aforementioned agreements, in the last 10 years the use of 
those public health safeguards has been limited, because of the 
multinational pharmaceutical corporations’ and governments’ pressures on 
WTO members to about compulsory licenses granting. As the United Nations 
High-Level Panel on Access to Medicines (UNHLP) stresses in its report 
“the sovereign right to issue compulsory licenses provided for by TRIPS 
has been stymied by threats of retaliation from governments and 
corporations against countries who have followed the prescribed process 
set out in TRIPS”. Such intimidations have undermined the efforts of 
governments to meet their inalienable duty to protect health, impeded 
access to innovative medicines by the population that requires them, 
constrained public health budgets and limited local manufacturing 
capacities, among other consequences.

An example of this situation is the Colombian case. Because of the 
interest of Colombia of issuing a compulsory license for imatinib 
(marketed as Glivec® or Gleevec® by Novartis) we have recently faced 
threats like the ones mentioned by the UNHLP. The most recent one can be 
found in the attached letter (“AFIDRO's letter to the office of the 
President of Colombia”).

This letter is the follow up that the group that gathers multinational 
pharmaceutical companies in Colombia (AFIDRO) makes of a meeting held at 
the beginning of 2017 at the office of the President of Colombia between 
them and high-level officials of the government, involving the special 
representative for the accession of Colombia to the Organization for 
Economic Co-operation and Development (OECD).

In such letter AFIDRO condemns the efforts of Colombian government to 
use its right to declare medicines of public interest as a previous step 
to proceed with compulsory licenses, which is one of the public health 
safeguards retained by WTO Members to meet their obligations to respect, 
protect and fulfil the right to health. They argue in the letter that 
the decisions made by the Ministry of Health in this issue, and in 
others sensitive to the industry “would do considerable but justified 
harm to Colombia’s aspirations to get closer to the group of countries 
committed to the best policies to improve its citizens’ lives” (own 
translation), which clearly refers to Colombia’s aspirations to become 
member of the OECD.

As a response to this pressure, and just before the presentation in 
Paris of the advances of the Colombian government in the process of 
becoming an OECD Country Member, the Government of Colombia issued a 
decree that modifies the procedure to declare anything in Colombia of 
public interest, making it more difficult to issue a compulsory license 
in the future. Therefore and unfortunately, this decree has been 
understood as a requisite to be part of the OECD.

What changes would you like to see happen to improve access to 
innovative therapies?

The current framework of access to medicines vs TRIPS innovation model 
has leaded human kind to the necessity of identifying solutions for 
“remedying the policy incoherence between the justifiable rights of 
inventors, international human rights law, trade rules and public health 
in the context of health technologies”. Such task has been assumed by 
the United Nations Secretary General through the High-Level Panel on 
Access to Medicines which “views innovation and access to health 
technologies as a multi-dimensional and global problem that affects all 

In this train of thought the main changes to improve access to medicines 
that we suggest are:

Firstly, a broad implementation of the recommendations made by the 
United Nations High Level Panel on Access to Medicines in its report 
(http://www.unsgaccessmeds.org/final-report/). We encourage OECD 
countries to commit with their recommendations, as they address the 
major changes affecting access to medicines nowadays.

Secondly, considering the above-mentioned specific situation facing 
Colombia, an official recognition of the OECD that using as much as 
possible TRIPS-public health safeguards, as it is recommended by the 
Doha Declaration on TRIPS and Public Health, is both a good and required 
policy to improve people’s welfare. Such pronouncement would bring 
clarity to the situation in Colombia and, furthermore, will promote the 
future implementation of TRIPS-public health safeguards included in the 
TRIPS Agreement so that counties be able of fulfilling their human 
rights and public health obligations.

El 04/05/2017 a las 7:23, Jamie Love escribió:
> ​​
> KEI submission to OECD consultation on "Sustainable access to innovative
> therapies"
> ​​
> This was the KEI submission to the OECD consultation on "Sustainable access
> to innovative therapies," which involved four questions posed by OECD on
> access to medicines.
> ​Question 1: ​
> Reflecting on the last 5-10 years, what do you think have been the major
> changes affecting access to medicines?
> The notion that governments can manage prices under monopolies has taken a
> beating. The 2016 ESMO European Consortium Study on the availability,
> out-of-pocket costs and accessibility of antineoplastic medicines in Europe
> illustrates how unequal is access to new drugs for cancer, but also how
> access is restricted even in very high income countries. And, things are
> getting worse. Everyone seems to notice this except for trade negotiators,
> who continue to act as if all the system needs are higher and higher
> prices, and broader and more durable legal monopolies. Technology
> assessments on the value of new drugs are just the latest false hope that
> the current system can be tweaked, without a more fundamental questioning
> of the grant of a temporary monopoly as a right, rather than a privilege.
> But with each new drug registration, the higher and higher prices are
> leading to disparities and financial challenges that can no longer be
> ignored. And, also relevant, most countries have a growing percentage of
> persons over 65 and growing dependence ratios, and this compounds
> sustainability challenges.
> [175 words]
>> ​Question
> ​2​
> :
> ​ ​
>> What are the top three issues that must be addressed to ensure access to
> innovative medicines while maintaining financial sustainability of health
> systems?
> Issue 1. In the short run, government need to treat monopolies granted via
> patents, test data and other measures as privileges that can be revoked if
> prices are unreasonable. This means dusting off the old compulsory
> licensing mechanism, and doing it once in awhile to make a point.
> Issue 2. As governments implement measures to curb and moderate prices,
> they need to ensure that investments in R&D don’t suffer. The only
> justification for high drug prices is that they are an incentive to invest
> in R&D. If you aren’t going to accept very high prices, you should
> compensate by a combination of expanded direct funding, subsidies and
> innovation inducement prizes.
> Issue 3. In the longer term, governments need to abandon the system of
> granting monopolies to finance R&D. What can be done right now is to
> undertake feasibility studies of full delinkage, which is a long term goal.
> Full delinkage involves the elimination of monopolies for drugs and
> vaccines, something that can’t be done overnight. Policies need to look at
> the feasibility, costs and benefits of full delinkage, but also look at the
> paths from now to the future, something described as the progressive
> delinkage of R&D costs from drug prices, over time. In the end, you want
> marginal cost pricing of products, and robust funding of R&D that is not
> based upon high prices of drugs. This is absolutely necessary to have
> universal access to new products, and to eliminate price based formularies.
> [249 words]
>> ​Question
> ​3​
> :
> ​ ​
>> Why do you think there are issues in ensuring access to innovative
> medicines while maintaining financial sustainability of health systems?
> If your system of funding R&D is based upon high prices, and you let profit
> maximizing businesses set those prices, the conflict between innovation,
> affordability and access is baked in.
> Access should be easy, because the drugs and vaccines are generally cheap
> to manufacture. The decision to make drugs expensive creates the access and
> unfairness problems.
> The policy to make something cheap expensive is the way policy makers have
> long embraced to finance R&D. It’s not as if there are no alternatives to
> expensive drugs. Rather, there is opposition to even studying alternatives.
> Some countries are currently lobbying against a resolution at the WHO to do
> a feasibility study of delinkage. Why? Because big drug companies that have
> political influence in these countries don’t want the studies done. One
> large drug company explained that big pharma companies are good at
> exploiting the opportunities that legal monopolies create, and they would
> not benefit from a shift to delinkage models, where innovation in new
> products are rewarded, but marketing products are not.
> Some people profit a lot from the existing system, and they don’t want it
> to change. But the people who pay for the current system are being
> exploited, they pay too much for every dollar invested in R&D, many are
> confronted with difficult financial burdens, and millions are excluded from
> access to medicines they need.
> [225 words]
>> ​Question
> ​4​
> :
>> What changes would you like to see happen to improve access to innovative
> therapies?
> As mentioned above, in the short run, make it clear that the temporary
> monopoly is a privilege, not a right, and grant a compulsory license or
> otherwise terminate the monopoly when companies insist on prices that are
> unreasonable, unaffordable and/or unsustainable. Regardless of whatever
> theories you embrace regarding what constitutes a fair or reasonable price,
> unless you can threaten to end the monopoly, the drug manufacturer will be
> able to threaten to withhold the drug from the market. Being serious about
> access is also being serious about having the power to make that happen.
> Governments can do a lot to make manufacturing more competitive, by
> requiring more disclosure of knowhow, data and materials, including, for
> biologic drugs things like cellular clones stocks, Plasmids/ sequences, and
> physicochemical/ biophysical characterizations, as well as information on
> methods of production, such as growth conditions/ protocols, and
> extraction/ purification protocols. Patent landscapes on all drugs and
> vaccines should be more transparency, particularly for biologic drugs.
> To make better policies, all sorts of better data is needed. Companies need
> to routinely disclose the costs of each clinical trials, all public sector
> R&D subsidies, including tax credits, and make licensing practices for
> transparent for the public, rather than only when such information is
> material to investors.
> In the longer run, full delinkage is the only policy that puts patient
> interests first, and allows governments to be more efficient in funding
> R&D. Consider, for example, the market for HIV/ARV drugs. In 2015, the
> global ARV/HIV market was more than $24 billion. Despite these massive
> outlays, the rate of innovation is just one novel drug per year, for the
> past three decades, and the prices are so high governments and insurers
> ration access to the best new products. How do we justify spending $24+
> billion per year to get one new drug per year, and then limit access to the
> best drugs? By pretending there is no alternative, when there clearly is.
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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