The scandal of the access to antiretrovirals in Portugal
In Portugal, the access to antiretrovirals (ARVs) before their marketing authorization (MA) but when they are already vital to patients in therapeutic failure is not only limited to a small minority of patients, but also takes place later than it should (sometimes when the patients are in functional mono-therapy), leading to early deaths.
As we all know, in order to control the viral replication and to avoid the rapid emergence of resistant strains, it is absolutely necessary to have more than one active ARV. At present, as many patients are responding only to T20 (Fuzeon®) and tipranavir, it's necessary to have both drugs available in order to build a viable therapeutic regimen, instead of using them in a sequential monotherapy way (using, first, only one of the two, and then, when the first doesn't function anymore, using the other), which is a very quick way of developing resistance to both drugs.
Another common problem in Portugal is that patients have to wait a long time for alternative therapeutic solutions, which means that, when (if ever) they have access to the new drugs, their immune system is already damaged to such an extent that it reduces the chances of longterm therapy success.
This siuation happens because of:
- Pharmaceutical companies, which not only have been reducing the number of patients in Expanded Access Programs, but also have been continuously rising the price of new drugs (Fuzeon®, Reyataz®, Kaletra®, etc.). Boehringer Ingelheim (BI), for example, wanted to charge in our country 26 euros per day and per patient for tipranavir, before its marketing authorization.
- The incompetence of those responsible for the health laws and regulations, as well as the agencies whose job is to inspect these activities.
- Hospital administrations which, based on economic reasons only, severely restrict the number of patients that can have access to the drugs.
- Inadequate medical prescription.
The tipranavir case
This drug is a new PI produced by BI –recommended for patients with multiple resistance and without any therapeutic alternatives– which is still in process of approval by the EMEA.
In general, a drug in this phase of approval is made available for free to patients with no therapeutic alternatives, throughout the Expanded Access Programs (EAPs), once called Compassionate Access Programs.
As we mentioned above, the pharmaceutical industry is not the only one responsible for the problems in accessing drugs that still don't have a marketing authorization (MA).
Indeed, in the past, with other drugs that still didn't have a MA but were already freely distributed through EAPs, the number of hospital requests was much lower than one should expect (based on epidemiological studies and the knowledge of real cases). We can say that only about 20% of the patients in need received the drugs, which is totally unacceptable and maybe explains why Portugal is the only country in the former 15-country EU where AIDS is the leading cause of death in the 20-39 year old group.
In the meetings with BI International, the Portuguese treatment activists (who, in some cases, are also members of the ECAB) realised that the situation in their country was very different from the situation in their EU neighbours, as, for instance, in Spain:
In Portugal: Boehringer Ingelheim Portugal ”gave“ tipranavir at a cost of 26 euros per day
3 patients were being treated
In Spain (which has a population only 4 times bigger than the Portuguese), Boehringer Ingelheim Spain gave the same tipranavir for free
500 patients were being treated
According to epidemiologic data on resistances, if there are now 500 patients on tipranavir in Spain, there should be at least 100 to 150 patients receiving the same drug in Portugal.
The negotiations
In January members of the Treatment Activist Group ”Pedro Santos“ (GAT), together with representatives from several Portuguese Infectious Disease Centres, started a long process of dialogue with both Boehringer Ingelheim International and Boehringer Ingelheim Portugal.
On April 8th 2005, following a Boehringer's proposal according to which they would supply the drug for free, but under certain conditions that we believed were not and should not be for us to be held responsible for, we talked to the Ministry of Health, as well as to the Administration of Health, regulatory agencies, hospital boards, as well as several hospital department directors and clinicians for them to take their responsibilities, in order to overcome the administrative and legal barriers, so that finally the drug could be provided to everyone in need.
Conclusion
From that moment on, we do not know which (and if) other organizations participated in the process, influencing its outcome. We think, however, that our contribution in the process –as members of the community, both at a national level (through ”GAT-Pedro Santos“), and at an European level (through ECAB)– was of great importance.
It's with great pleasure that we now transcribe the letter sent on April 21st by Boehringer Ingelheim Portugal to several institutions (hospital boards, hospital department and service directors, clinicians, etc.):
Subject: Expanded Access Program to tipranavir
In the sequence of the contacts that we have been making with your institution in the context of the Expanded Access Program of our drug tipranavir, we now wish to inform you that we have decided to make the drug available for free to all the people infected with the HIV virus, for a certain period of time.
Although we have been informing the Portuguese hospitals of this program since 2004, several of these institutions did not consider applying to the program in time, and are now facing budget limitations.
Boehringer Ingelheim understands the problem of the access to tipranavir and, in order to overcome this situation, we want to let you know that we are making the drug available for all of those in need, until the end of December 2005, after INFARMED's (the Portuguese Drug Agency) pre-marketing authorization.
We ask each hospital board all the information they can give us, so that we can proceed with the purchase of all the necessary doses.
Tipranavir will be delivered soon after the reception of the request, which should indicate the pre-marketing authorization that allows it and the reference to the zero cost that this offer implies.
This decision shows that we are willing to take our responsibilities in the resolution of the problem. It's now time for the other partners to take the appropriate steps to overcome the situation.
Finally, we would like to stress our openness and availability to discuss all the remaining and relevant issues concerning this program.
Yours sincerely,
Boehringer Ingelheim, Lda.
Dr. Carlos Trabulo
Medical Director
Dra. Raquel Redondeiro
Clinical Monitor Local
The access to tipranavir when a patient is in therapeutic failure
(Letter sent by GAT –Portuguese Treatment Activist Group ”Pedro Santos“, on April 7th 2005, to INFARMED –the Portuguese Drugs Regulatory Agency–, to the directors of several Infectious Disease Departments, to the National Health High Commissioner, to the National Health Regulatory Body and to the Ministry of Health)
In the sequence of the RESIST study and other relevant clinical trials, and while, at the EU, the process of approval and marketing authorization of Boehringer Ingelheim's new drug tipranavir is taking place, this pharmaceutical company has been distributing the drug in several EU member states through Expanded Access Programs, according to each country's laws.
In Portugal, however, the legislation that regulates the drugs eligible for expanded or compassionate access remains unclear. In this legal context, the pharmaceutical company Boehringer Ingelheim (BI), with the ignorance or consent of the regulatory agencies –whose legal and statutory purpose and mission is to promote people's rights and health–, has been ”offering“ the hospitals its drug through a procedure called Authorization for Use of Experimental Drugs, since November 2004, at a price of 26 EUR per patient.
As this situation created a series of problems in the access to the drug (in fact, only 3 patients are receiving tipranavir when it's estimated that around 100 are in need of the drug), our group, GAT, took the initiative, in order to overcome the situation, of negotiating with the pharmaceutical company.
Our position is that drugs such as tipranavir –which still lack a marketing authorization but are absolutely necessary for salvage therapy– should be made available for free, as it happens in other EU countries like, for instance, Spain.
The negotiations with BIPortugal resulted in an agreement that guaranteed the free access to the drug until the number of 100 patients was reached and until the end of December 2005.
The pharmaceutical, however, wanted our group (GAT) to become responsible for the payment to the hospitals, with the money from a BI Portugal fund specially created for the occasion. The company would, therefore, import and then distribute the drug to the signing hospitals.
We are very pleased to see that BI Portugal put the health of the patients before the economic and budgetary issues.
We think, however, that it's not our duty to become responsible for the payments, even if the money comes from the fund created by Boehringer Ingelheim- Portugal.
As an NGO we did what we think is our job and what we are able to do. Now it is for the Ministry, the Health Administration, the regulatory agencies, the hospital administrations, the hospital department directors and the clinicians, for all of them to take their responsibilities.
By pointing all this issues out, we'd like all the agencies and the people with responsibilities in this field not to miss the opportunity created by BI Portugal and to, therefore, overcome the legal and bureaucratic obstacles in order to guarantee an effective and in time access to drug for all of those in need.
GAT (Portuguese Community Advisory Board),
Board of Directors, Lisbon, April 7th 2005
Pedro Silvério Marques, Guilherme Bandeira de Campos and Luís Mendão
EATN - European AIDS Treatment News, Volume 14, II – Autumn 2005
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