Letter |

Merck response to MSF letter of 26 February 2004

7 min

To: Ms Ellen ‘t Hoen, Interim AC Director

Dear Ellen:

I am writing in response to your letter of February 26, 2004, to Mr Raymond V. Gilmartin concerning the registration status of the 600 mg formulation of STOCRIN in developing countries and Merck’s pricing policy for STOCRIN.

We share MSF’s objective of ensuring access to quality medicines for people living with HIV and AIDS in developing countries. That is why we implemented a new HIV pricing policy in March 2001 to provide our antiretrovirals at prices at which we don’t profit in the poorest countries and those hardest hit by the epidemic (i.e., low Human Development Index (HDI) countries and medium HDI countries with adult HIV prevalence of 1% or greater). That is why we have engaged in a wide range of related activities to help improve access to HIV care and treatment in the developing world, including, for example, our partnership with the Government of Botswana and the Bill & Melinda Gates Foundation to help transform Botswana’s response to the epidemic across the entire spectrum of prevention, care, treatment and support. And that is why, as registration has proceeded, we have introduced the 600 mg formulation of STOCRIN at 95 cents per day in a number of developing countries that are low HDI or medium HDI with an adult HIV prevalence of 1% or greater — exactly what we promised to do in October 2002.

We welcome informed dialogue on access issues, as you and your colleagues know from our regular communications over the past several years. We appreciate the concerns that you expressed in your letter, and stand ready to work with MSF to address legitimate issues related either to the availability of our products for your treatment programs in developing countries or to broader policy questions. However, there are a number of inaccuracies in your letter and the related press release that MSF issued last week, which seriously misrepresent the actual situation regarding access to the 600 mg formulation of STOCRIN in developing countries.

I would like to take this opportunity to update you on what Merck is actually doing and to clarify several points where there may be misunderstanding. Since receiving your letter, we have again checked the registration status of STOCRIN 600 mg in all of the countries where MSF is working, as well as investigating each of the claims MSF has made.

As of today, the 600 mg formulation of STOCRIN is registered in 36 developing countries, and registration is in process in 23 more. Of the 23 countries in which MSF is working to provide treatment (based on a communication from your colleague, Fernando Pascual), the new tablet is already fully approved in 11 countries; available also in three additional countries through pre-licensed sales or other early access mechanisms; and registration is pending in 7 others. As you are aware, Merck cannot control the pace of registration in developing countries, which is the responsibility of government. But we do work closely with the regulatory authorities to help ensure that people who need our medicines can gain access to them as expeditiously as possible.

Let me address the specific points raised in your letter:

  • In South Africa, we applied for fast track registration of the 600 mg formulation of STOCRIN 600 on 23 October 2002 – the day we made the announcement about our pricing policy for the tablet. To date, South Africa has not completed its review, but we are hopeful that registration approval will be granted soon.
  • In the Democratic Republic of Congo, the 600 mg formulation of STOCRIN was granted approval in April 2003, and in Mozambique we received special approval in October 2003.
  • In Malawi we applied for registration of the 600 mg formulation of STOCRIN in December 2002, in Zimbabwe in January 2003, and in Kenya in January 2003. Registration approvals in these countries are still pending, but STOCRIN is available in Kenya through pre-licensed sales.
  • Product registrations in Nigeria must be submitted by the importer on behalf of the manufacturer. We have been working with the importer in Nigeria regarding filing issues.
  • In Indonesia, we applied to the regulatory agency for pre-registration of the 600mg formulation of STOCRIN in February 2003. The agency requested further documentation related to the Certificate of Pharmaceutical Product. This information has been provided and the file resubmitted to the regulatory agency.
  • You raised an important point about the distribution channels in Mozambique, over which we have no control. Wherever possible, we have negotiated lower fees with our distributors to ensure that the price to patients is as close to Merck’s ex-factory price as possible. Customs duties, import fees, and other taxes and business fees can often add a significant amount to the final price for antiretrovirals, as MSF has pointed out in your “Surmounting Challenges” report. This is an area where we would welcome MSF’s collaboration – to work with all stakeholders at country level to improve the efficiency of distribution channels and ensure that Merck’s differential prices for antiretrovirals provide maximum benefit to patients.
  • As announced on 23 October 2002, we made a commitment to introduce the new 600 mg formulation of STOCRIN at 95 cents/day in low HDI countries and medium HDI countries with adult HIV prevalence of greater than 1%. As noted above, that is exactly what we are in the process of doing. We were already providing – and have continued to provide – the 200 mg formulation of STOCRIN at the higher price of $1.37/ day in the same set of countries. Based on our policy, and due to different manufacturing processes for the capsules and the tablets, the end prices for both products are different – but each is set at a level at which we do not profit in the poorest countries and those hardest hit by AIDS.
  • STOCRIN and CRIXIVAN are priced in US dollars. The pricing actions taken last year in South Africa were adjustments for local currency fluctuation, not increases in the dollar-based price of our antiretrovirals. (This applied to both Malawi and Kenya as well. In Kenya, where we supply through a local distributor, the prices of STOCRIN are somewhat higher in Kenyan shillings due to a combination of customs duties, importation levies, and exchange variation.)
  • With respect to the supply of the 50 mg formulation of STOCRIN in South Africa, to our knowledge no patient, physician or pharmacist has contacted MSD South Africa to report that they were unable to refill their prescription. (Although there was a temporary shortage at the factory level for a few days in January due to a large unexpected order for Botswana, the product was available elsewhere in the supply chain in South Africa.) Had we learned of such a case, where a patient’s supply might have been interrupted, Merck’s policy is to take action to obtain the necessary medicine from our international supply chain.
  • When I was contacted by MSF about supply issues for STOCRIN in Indonesia, I put your local office in contact with our office in the region. I understand that they are now addressing the questions you brought to our attention.

I hope that this letter has clarified the situation with respect to access to the 600 mg formulation of STOCRIN in the developing world. We will continue to provide STOCRIN in the poorest countries and those hardest hit by the AIDS epidemic at prices at which we do not profit. We remain committed to work in partnership with all constructive stakeholders to ensure access to our medicines in the developing world, and we share your concern about making a difference in the lives of those living with HIV and AIDS.

Please continue to contact us when you have questions about access to our antiretroviral medicines. I will be glad to meet with you and your colleagues for further discussion of any of the issues raised in your letter.


Jeffrey L. Sturchio
Vice President, External Affairs
Human Health – Europe, Middle East & Africa
Merck & Co., Inc.