An Interview With Medicines Patent Pool Board Chair Marie-Paule Kieny.
08/02/2018 BY CATHERINE SAEZ, INTELLECTUAL PROPERTY WATCH
The unexpected announcement in December of the resignation of the Medicines Patent Pool executive director left the Pool searching for its new head. Marie-Paule Kieny, former World Health Organization assistant director general, now chair of the MPP governance board stepped in to oversee the MPP while the search goes on. She sat down recently for an interview with Intellectual Property Watch to explain that MPP is conducting business as usual, and is keeping firm in its plan to release the results of a feasibility study analysing the possibility for MPP to extend its licensing activities to other essential medicines still under patent.
Intellectual Property Watch (IPW): The Medicines Patent Pool director left recently, at a time when the organisation has been considering expanding its areas of focus. Could you explain the current situation?
Marie-Paule Kieny (MPK): Let me clarify, I am the chair of the governance board of the MPP, where I succeeded Sigrun Møgedal in September 2017. The MPP Board has approved a feasibility study to look at the value for MPP of extending their model of voluntary licensing in order to drive competition and to reduce the prices of medicines. We are interested in licensing as a mean to increase access through competition of several manufacturers to reduce the price.
So the Board has approved a feasibility study to see whether there would be public health value in extending the MPP model beyond the diseases that we already working on right now, which are HIV, tuberculosis and hepatitis C.
The study is still ongoing, and is financially supported by the Swiss government, and we will very soon have the results of the interviews of various stakeholders to see if we extend, and what would be the scope.
We intend to launch the new strategy and to present the result of the feasibility study at an MPP event around the next World Health Assembly (21-26 May).
The scope of expansion is around the WHO list of essential medicines (Model List of Essential Medicines [pdf], the latest dated March 2017). As you know, 90 percent of medicines on the essential medicines list are not patented anymore, they are generics already, so we are not interested in those. We will be looking at the latest additions, which are patented, and whose patents are still running for a few years, to see whether driving generic competition through licences given by the originators to the MPP and the MPP being able to sub-licence to generic companies, is likely to have an impact on access.
We negotiate licences with originators, Gilead or Merck, for example, and the negotiation that we have is about the conditions of the licence. Some of the manufacturers on some products require royalties, on some others there are no royalties at all. The scope in terms of territory where those licences apply can also be variable. Currently, the largest territory that we have for a licence is 130 countries. We do have licences for middle-income countries, but not all of them.
When we have a licence, we open a call for expression of interest by generic manufacturers, we have an assessment of the quality of what they propose to do, and if they fit with a minimum quality, and we provide them with a sub-licence with which they can start the generic development.
IPW: Who assesses the generic manufacturers, and the quality of generics?
MPK: Initially the assessment was done internally by our business development group, but currently we have a panel and we are working towards having an independent panel of experts that would do the first independent assessment to have it completely transparent and non-biased. The recommendations of those experts would go to the Board.
All the generic companies entering into the competition are pre-qualified by the WHO. The reason why is that in the HIV world, the market supported by MPP, is the one of large procurers, the Global Fund [for AIDS, Tuberculosis and Malaria], and Unitaid and they need prequalification.
For the other drugs, we might be working on the essential medicines list for cancer, hypertension, or diabetes. There is no procurement agency and the drugs would have to be purchased domestically. We have to see whether therefore there is a need to review the quality requirements and if prequalification remains a condition for local production, but this is still not decided.
We are looking at the opportunity and potential public health impact on moving towards working on generic licences for essential medicines still patented.
The discussions on the potential expansion of the essential medicines list has been initiated under the leadership of Greg Perry [who left at the end of 2017] but the process is ongoing and we are still in line for having the results and the strategy launched around the World Health Assembly in May this year.
IPW: Do you have an idea of the number of medicines that could be covered by the extension?
MPK: We would start with a handful at first. The next review of the essential medicines list is coming up and we would like to work with them in advance, before the decision to see whether there is some preliminary work that can be done.
At the moment we are interviewing many people for the feasibility study, we are interviewing manufacturers, originators and generic companies. Some of these drugs are different. Until now, the MPP has been working on drugs that are chemical, but the essential medicines list includes vaccines and biosimilars, which are different in nature.
So we may start with drugs which are defined molecular entities.
IPW: Would you say that there are many generic manufacturers able to deliver biosimilars in developing countries?
MPK: No, there are not many companies in developing countries able to manufacture biosimilars, but biosimilars might interest also vaccine manufacturers, because they do manufacture biologicals. We have to see what can be done.
So it is likely, if we expand, if we have an agreement of the Board, that we will expand rst on essential medicines which are de ned molecular entities, which the companies we are already working for HIV, TB and hepatitis C could make.
IPW: What is the basic underlying financial criteria of medicines selection?
MPK: This is not decided and the Board is waiting for the feasibility study, but I would imagine that the priority would be on those medicines for which the price is so high that actually having generic competition makes sense.
IPW: It seems that biosimilars are so di cult to manufacture that it is not likely that generic competition would lower the prices signi cantly.
MPK: This will be a question of regulation. If the regulatory agency asks that the whole clinical development be redone, then it will be expensive, but as I said, we are likely to start with chemical molecules and not biosimilars.
IPW: Is there going to be a phasing-in of additional medicines?
MPK: It could be and one of the reasons is that the MPP needs to find other financial support for those new medicines, because for the time being, apart from the Swiss, who are financing the feasibility study, the whole financial assets of MPP come through Unitaid funding. And the mandate of Unitaid is only on HIV, TB and hepatitis C, so we cannot use their financing to work on diabetes, for example.
This is why it is very important for us to have support by the WHO Executive Board, during which the MPP and the expansion of its mandate was mentioned several times. When countries express political support, I hope that they will also extend financial support.
The MPP is relatively inexpensive for a big impact, as it is mainly human resources to negotiate licences.
IPW: Will you use the same approach the MPP uses now with the new medicines in negotiations with patent owners?
MPK: Yes, this is the expertise of the MPP. The drugs which could be selected have a different environment in terms of business and market. For HIV, you have the Global Fund, and you have Unitaid, so you have big purchasers. For those medicines, you can a ord to have the highest number of producers and the highest impact on prices. And for some of those HIV drugs, prices have gone too low.
On the essential medicines list drugs, there will be national purchasers only, so the markets are different and we also have to see if this has an impact on the number of licensees for each of these drugs.
There is the need to have some understanding of the market, once you have these drugs, who buys them, with which finances? For HIV, the discussion about local production was not that [important] because the procurer is the Global Fund or UNITAID, so what they are looking for is the lowest price.
If you are talking about essential medicines list cancer drugs or diabetes, for the countries who do the purchasing, local production might be something which is of value. It is a different environment, so we have to see what, if anything, needs to be fine-tuned or adapted in the way we do business right now.
For MPP Board, we have a new procedure. Board seats will be filled through nominations, thought an open call for nominations.
IPW: What is the timeframe between now and the Health Assembly?
MPK: As you know Greg Perry has left. The Board was happy with his work, but he had an opportunity with the IFPMA. He had been at the MPP for five years, as you know, people change jobs and it was the right time for him. He left on good terms and we hope that in his position at IFPMA he will remember MPP and might facilitate the discussions with some of the multinationals for us, you know.
In the interim, I am not an interim executive director, one of the reasons is that I am a full-time employee of the French National Institute of Health and Medical Research (INSERM) so I can’t have two jobs. I am overseeing the secretariat in the interim period on behalf of the Board. It is unpaid function.
It is in my interest and everybody’s interest that this period does not last for too long. The post has been advertised before Christmas on our website. We just hired a headhunter who will handle the recruitment. The intention is to be able to have a contract with a new executive director before the World Health Assembly because we want the new person to be able to come to the World Health Assembly and see everybody. In the meantime, operations continue as usual.
IPW: Is the MPP discussing the issue of some middle-income countries having a high burden of HIV, TB and Hep C not covered by MPP licences?
MPK: Yes, it is an open discussion. We have had licences which were more restricted which were then opened at a later stage. What we would like to discuss as MPP – and it is part of the strategy – would be whether we can o er a solution to multinationals for middle-income countries, the ones which are not covered, such as Indonesia, Thailand and Malaysia, and to see if it could be possible, for example through tiered royalties.
You can always be on the romantic side and think that medicines should have the same low price everywhere. Sure, I’d be very happy, but medicines are priced differently in different countries, for example, medicines are about 3 times more expensive in Switzerland than in France, that is what reality is like.
There is an expectation that prices of medicines will be more expensive in Thailand and Malaysia, than in Haiti, or Malawi. We still think that the MPP could provide solutions. This is part of the work on the new strategy, and how we can add more value to it, for more population. MPP remains and needs to be centred on public health and access to medicines. Yes, we negotiate deals, but the primary objective is to increase access.
IPW: Thank you.
William New contributed to this report.