MENA CAB Report

Community Participants

Hussein Zahid Sustainable Resource Foundation, Pakistan

Souhaila Ben Said Association Tunisienne de Lutte contre les MST et le

Sida,Tunisia

HebaWanis Egyptian Initiative for Personal Rights, Egypt

Khaled Omer Sudanese people living with HIV care association, Sudan

Fatiha Razik Association de protection contre le sida (APCS), Algeria

Mohamed Mazen Affiliation? Jordan

Fatimata Ball Secrétariat Exécutif National de Lutte contre le SIDA,

Mauritania

SanyKozman Middle East and North Africa network of harm reduction,

Egypt

Rita Wahab Soins Infirmiers et Développement Communautaire &

Vivre Positif, Lebanon

Mohammed Dadsi Association de lute contre le sida (ALCS), Morocco

Habachi Abderrahim Association de lute contre le sida (ALCS), Morocco

Zakaria Bahtout ITPC-MENA, Morocco

My Ahmed Douraidi Association de lute contre le sida (ALCS), Morocco

Othman Mellouk ITPC-MENA, Morocco

Pauline Londeix MENA-CAB Consultant

Amal Ben Moussa MENA-CAB Coordinator,Association de lute contre le

sida(ALCS), Morocco

First meeting of Middle East and North Africa

Community Advisory Board

Industries and organizations Participants

ViiV Healthcare Scott Purdon. Director Access and Government Affairs

Gudrun Maechler. Director Medical Affairs

Medicine Patent Pool Esteban Burrone. Head of Policy

Abbreviations

ABC: abacavir

ARV: Antiretroviral (class of drug)

CAB: Community Advisory Board

DTG: Dolutegravir

FDA: United States Food and Drug Administration

IP: intellectual property

NGO: nongovernmental organization

PLHIV: person or people living with HIV/AIDS

TRIPS: Trade related aspects of intellectual property rights (World Trade Organization)

WHO: World Health Organization

MPP Medicines Patent Pool

Background

Despite the fact that HIV prevalence in the countries of the Middle East and North Africa is

believed to be low at least among the General Population, the rate of increase of new cases

since 2001 makes this region home to one of the most fastest-growing epidemic in the World.

The annual number of new cases continues to increase in the MENA region unlike other

regions of the world, like in sub-Saharan Africa, where the number of new cases have been

significantly decreasing(34% decrease) or in the Caribbean region (49% decrease). In parallel,

MENA Region is reported to be the region with the lowest access to care and treatment in the

World (11%)

Pharmaceutical companies use the World Bank classification, which is based on the income

of countries, to define their access policy in the world. According to this classification the

majority of countries in the MENA region are considered as middle-income countries.

However, the United Nations Committee for Development Policy uses three criteria for

identifying countries as least developed countries: gross national income per capita, the

human asset index, and the economic vulnerability index. This results in a larger number of

poor people living in middle-income countries than in low-income countries.

Because pharmaceutical companies consider the countries in the MENA region as

intermediary countries, the price of their products are much more expensive than in low-

income countries. Another consequence is that the countries in the MENA region are

excluded from voluntary licenses, which means they can’t have access to generic drugs which

usually propose the same molecules, but for affordable prices compared with prices provided

by originators. Also the originators often use different strategies, like “evergreening”, abusing

their rights related to the intellectual propriety to block generic manufacturers for as long as

possible. As a result, the access to new generation ARVs in these countries stays limited.

Actually the third-line treatment in these countries is too expensive. For example, in Morocco,

where there are 5500 people on treatment, the amount spent on the procurement of third-line

treatment for 20 people (at US$ 1700 per patient per month, or US$ 20 400 per patient per

year) is equivalent to the amount required for treating 1700 people on first-line medicines (at

US$ 240 per patient per year).

The Middle East and North Africa Community Advisory Board (MENA-CAB)

The creation in September 2013 of a Community Advisory Board for the first time in the

MENA region was a regional initiative of the Association de Lutte Contre le Sida (ALCS) in

Morocco in collaboration with ITPC-MENA.

The main objective of the MENA-CAB is to ensure a dialogue at the regional level among all

of people living with HIV and / or hepatitis C, treatment advocates, and representatives of the

pharmaceutical industry and policy makers in order to ensure improved access to treatment,

care, and support for patients. The MENA-CAB is managed by a Steering Committee

composed of 6 members from 5 different countries (Table 1)selected to reflect geographical

representation, sexual orientation and gender identity, knowledge, community credibility, and

honesty as much as possible.

This committee decides on the program and participants in meetings and activities of the

MENA-CAB while the legal and financial control is provided by ALCS.

Before the Steering Committee, an ad hoc Experts Committee was constituted ad hoc and was

temporary; its role was in agreeing the terms if reference for the full time elected Steering

Committee and preparing and agreeing the criteria for selection, process of invitation, self-

nomination process, timescales and process of acceptance of self-nomination of individuals to

be Steering Committee members. This was fully achieved by the Experts Committee which

was then terminated leaving the floor for the Steering Committee (SC).

The role of the Steering Committee is to:

Decide the work plan, in consultation with members

Agree the programme for CAB meetings

Approve participants to the meeting

Set and monitors the budget, in consultation with the secretariat

Seek funds, in consultation with the secretariat

Update the administrative and governance procedures for the CAB, in consultation with

the secretariat

Select a Chair and Deputy Chair for CAB from among Steering committee members

Appoint other voluntary officers as needed from among its number or the members.

Adjudicate on the participants to be invited to the CAB.

The first MENA CAB Session

The Steering Committee sent via his secretariat, invitations for participation to Gilead, ViiV

healthcare, BMS, Janssen, MSD/Merck and Medicine Patent pool.

- Gilead has refused to attend because it thinks it is still building up its presence in the

MENA region and is not in a position to share a lot of information at this time

- BMS has rejected, because it was at the World-Cab meeting in Bangkok in February

- Janssen has sent out our request to its representatives in Morocco, who came to the

ALCS headquarter and met with the ALCS president and the MENA-CAB coordinator

in order to have more information about the MENA-CAB meeting but as of the time

of the writing of this report we did not yet receive any answer.

- MSD/Merck has accepted and confirms edits participation at first, but has cancelled it

afterwards by sending an email 2 days prior to the beginning of the event.

- Only ViiV healthcare and Medicine patent pool have accepted and attended the

meeting.

The first MENA-CAB meeting took place in two sessions. The first session focused on

capacity development and training of PLHIV, leaders and treatment advocates from the

MENA. This involved learning about the drugs and the factors that influence access to these

agents, especially intellectual propriety aspects. The second session of MENA-CAB meeting

took place in Casablanca on the 30th

of June and the 1st

of July and included a meeting with

the Medicine Patent Pool and ViiV Healthcare. The present report summarizes the main

discussions of the meeting.

Association de lutte contre le sida (ALCS) : Rue Salim Cherkaoui. Quartier des Hôpitaux. 20360 Casablanca. MAROC

Tél : 00 212 5 22 20 94 90, Web : www.alcsmaroc.ma

COUNTRY N° people

with HIV

Atazanavir

TDF COBI EVG, QUAD

Abacabir Dolutegravir Abacabir pediatric

Dolutegravir pediatric

Pakistan 87000

Morocco 30000

Yemen 19000

Mauritania 10000

Egypt 6500 Royalties Royalties

Tunisia 2300

Algeria N/A

Jordan N/A

Lebanon N/A

Libya N/A

Palestine (west bank &Gaza)

N/A

Sudan N/A

Syrian Rep N/A

Licenses of Atazanvir, TDF, COBI, EVG & QUAD, Abacavir,

Dolutegravir, Abacabir pediatric and Dolutegravir pediatric in countries of the MENA region



AGENDA OF THE MEETING

June 28th 2014 - Day 1

8h30-09h00 - Welcome and Logistic issues

9h00-10h00 - Opening session of the MENA-CAB meeting

- Welcome speech to the MENA-CAB

- Participants introduction: Situation in each country

- MENA-CAB creation, Principles of the CAB, Agenda

10h15-11:45- Session 1

- Course of the drug from the discovery of a molecule to its placing on the market and Propriety

intellectual issues

- General Discussion

BREAK (15mn)

12H00- 13H30- Session 2

- Discussion on HIV & HCV pipelines. Which therapeutic priorities for people affected with HIV &

HCV in the MENA region?

- Pharmaceutical companies pipelines presentation. Focus on HIV & HCV medicines patented by

ViiV Healthcare & Merck

- Discussion on the current main or specific identified needs by the participants in each country of the

MENA region

BREAK 45 mn

14h15-15h45 - Session 3

- HIV & HCV treatments, what commercial strategies for pharmaceutical companies?

- Main strategies from pharmaceutical companies for their HIV & HCV medicines (standardized

prices, tiered pricing, voluntary licencing, and merger and acquisition)

- Discussion: what consequences of these strategies for the access to HIV & HCV treatments in

MENA region countries?

15h45-16h00 Day 1 closing session & logistic issues




9h00-11h00 - Session 4

- Using TRIPS flexibilities in MENA countries, as a strategy to stimulate competition & to

improve the access to treatments

- Focus & discussions on TRIPS flexibilities and to oppose patents in MENA.

BREAK (15mn)

11h15-13h15- Session 5&6

- Patent landscape in the MENA region

- Voluntary mechanisms, including the Medicines Patent Pool, and the access to medicines in MENA

- Group work: Best strategies for access in some countries

BREAK (45mn)

14:00-16:00 - Session 7

- General presentation and focus on the Medicines Patent Pool & the MENA region

- Specific discussion for the meeting with the Medicines Patent Pool

15h45-16h00 Day 2 closing session




8h30-9h00 - Final discussions before the meeting with the Medicines Patent Pool

9h0-11h00- Meeting with the Medicines Patent Pool (MPP)

- Presentation from the Medicines Patent Pool

- Questions, comments &discussion

BREAK (15mn)

- Plenary debriefing of the meeting with the Medicines Patent Pool ; Lessons learned & next

steps

12:15-13h- Session 8

- The generic industry in the MENA region

- The generic industry in India

- Specific discussion on the issue of registration of medicines in each country. Strategy of the

pharmaceutical companies to block generics

BREAK (45mn)

14:15-16:00 – session 9

- General capacity building session for the meeting with ViiV Healthcare

- Discussion



July 1st 2014 - Day 4

9h-11h Capacity building session for the meeting with ViiV Healthcare

BREAK (15mn)

11h15-13h15- Meeting with ViiV Healthcare

- Presentation from ViiV Healthcare

- Questions & discussion

BREAK (45mn)

- 14h- 16h: Debriefing of the CAB

Day 4 closing of the MENA-CAB



Minutes of the meeting

1. Fatiha: During a negotiation with pharmaceutical companies, based on which criteria do you

decide the geographical scope of the license?

A license is a piece of paper, what you actually want is an impact to make sure that these

medications are available and accessible throughout the country.

We start from the basis of what is a company doing right now, what is their current policy?

We try to push the limit, with a country that would not normally be able to buy the generic.

The negotiation takes a long time for this reason; this is why it takes a couple of years

because we are working very hard to get all of the conditions that benefit the country that

these other companies cannot do. When we reach the moment when we know that is as

much as we can get, then we agree on the negotiation – we want it to be a significant

improvement over the status quo including certain conditions that would not otherwise be

available.

2. Heba: Are governments involved in the negotiation process? If yes, how? If not, why?

I have to be very frank and open with, we’ve never done this before, a patent pool of this

kind does not exist in any other field. About a year and a half ago we started interacting with

the governments that we wanted to work with, meetings and phone calls. The first thing that

we need to do is connect data, we have to make a solid case using current information about

1st line, 2nd line and the epidemic in the country. You will make the moral case, the access to

treatment case but often you also need to include the data in order to solidify your

argument. The second step is to try and see if they need that drug and how we can interact

very closely in order to bring the license to fruition. What we want is to convince the

companies that you want access to this drug and to this generic for the lower price. We’ve

been doing this a lot lately, especially with Atazanavir and it was disappointing. The reply we

are getting is that the drug is not registered there so how can they be procuring this drug? In

most countries if the originator company has not registered the product it becomes very

difficult for generics to produce the product. This should be an easy win because the

company is making zero money in this country, because they’re not selling the product. But

the governments are telling us that it’s difficult and they aren’t getting to it right now.

Dolutegravir is also not being sold because it is so new and people don’t know if it will work.

What we’re trying to say is we want to get them in now. We were trying to see how we can

get the Ministry of Health interested in moving.

A license can be amended as many times as the parties agree. We don’t want the companies

to say that you’re putting pressure on the countries to do this.

Meeting with Medicine patent pool



3. ZAKARIA: Given the scope of your licenses, it appears clearly that you are failing to include

MENA countries, why?

I’ll give an example with Dolutegravir. We managed to get Egypt, we couldn’t get Morocco or

Algeria. ViiV says that actually they have a strategy to make this product available in Morocco

and Algeria. There are commercial countries, where they expect to make a profit. So we push

and push in order to bring it here. ViiV originally had 67 countries benefiting and we got to a

stage where 120 countries could benefit. So do we drop this because of your region and not

allow all of these other countries to benefit? I wouldn’t call it a failure, it’s one of the biggest

challenges we have. We are going to be able to help some people and I think something is

better than nothing.

4. Douraidi: The main part of the work of the Patent Pool is based on negotiations. We know

that to negotiate you need to have leverage. What are your means to pressure

pharmaceutical companies during the negotiation process in order to accept your

conditions?

They have also been granted by the countries an exclusive right, which makes it difficult.

What do we have as pressure points? Not enough to be honest. There is strong pressure

from the government, social society and the global fund finance to do more. The royalties do

something but that is essentially it. In HIV there is a lot of pressure on the companies to try

and do more. We have to show them, we have to make a case for them in order to convince

them to do more.

5. Med Dadsi: What is the place of people living with HIV in the governance of the Patent Pool?

So we have people living with HIV in our governance structure, one of our board and three

people living with HIV in our expert advisory group (3/11). There is no person from the MENA

region right now and I think we should include someone. We have people from Kenya, from

Bolivia, from South Africa that are in our governance structures right now. I think even

beyond this we need to do a lot with communication.

6. Zahid: Do you think that you are adequately consulting with civil society?

Originally we were consulting more with the international groups, which was our key access

to civil society. We realized over time that we needed to talk to people more at the national

level of these countries in order to provide a better forum for communication and discussion

between people. There is lots of work to be done. What we are doing is discussing a lot with

civil society during the negotiation process but we cannot go public during that process.



7. Fatimata: In your media statements, you are claiming that thanks to the Patent Pool,

Subsaharan countries, including my country Mauritania, have access to treatments. How do

you make sure that these drugs are effectively available in my country and when?

The challenge we have is the following, when we are discussing with a pharmaceutical

company, we try to tell them low and middle income countries. Sometimes they say

Subsaharan Africa and sometimes they don’t include all of the countries. So far we haven’t

had much trouble with Mauritania. Our focus is countries with a higher disease burden and a

lower income. We have been going to every regional conference, international conference

and every CAB that I can go to in order to have these conversations. We are not doing

enough but gradually we are trying to do more and the licenses are getting better and better.

It’s still not enough and the mechanism, as it is a voluntary mechanism, is making it very

difficult for this to happen.

We have to be humble about what we do. We’re an organization of 14 people and we’re

trying to address hundreds of thousands of people. If the drug has a patent, it will be very

expensive, if there is no patent but a license, the generic country tries to come in and tender

the license. We have to be careful what we do as we are not the Global Fund or any other

giant international company. To the extent that there is a patent barrier, we are trying to

remove that barrier but there is an immense process we must work through to achieve this

goal.

8. Fatimata: Concretely, when are we going to access these medicines and at what price? As for

Tenofovir, it existed in Mauritania before your license, so nothing has changed. My husband

just died, 255 days ago, from lack of availability of 3rd line treatment. When are we going to

access Dolutgravir in Mauritania? And when will it be available in other MENA countries so

that what happened to him does not happen to others?

For the moment the products for the 3rd line are in negotiation with the other countries.

Perhaps in your region the access is not licensed for Dolutegravir. There is a lot of interest in

the generic form of Dolutegravir but there is the issue of time to put it on the market.

Without the license from the originators, it is difficult for the generic brands to commence

producing the product. We would think that the time would take between two and half to

three years. Sadly, it is the time that rests as the problem.

9. Othman: In Johannesburg, November 2012, you committed to disclosedata regarding the

impact of your Gilead license. Could you share this data with us?

For the patent in 2006 for Tenofovir, 106 countries that are in the process of buying the

access to these medications. The license is in the process of existing in 75 or 80 countries and

we working with our partners to try and bring this many other countries. Right now, we are

negotiating with our partners to bring these to about 140 countries.



The updated data is still in the process of being recorded and documented and we have true

data on this for very few countries.

10. Heba: (So) how do you measure your impact? Do you see yourself as a successful initiative?

Our generic licenses starting producing Tenofovir and many of them already had it. They are

producing it in more countries and don’t have to pay royalties there. We took the countries

with data, very few above the 95 and we are looking at the prices in these countries actually

paid, in some countries they bought from the originator and from others they bought them

from Cipla. The countries got the licenses in 2012 and started registering, which takes time.

The impact is now low but it is starting to go up, trimester by trimester. There are savings on

royalties for those countries. The Dolutegravir impact probably won’t come for three years.

The impact estimation is based on certain assumptions, until the end of the patent. I will

focus on making the drugs available sooner, better terms with the companies and putting

pressure on these companies.

11. Sany: Who sets the price of generic products developed through your licenses? How can we

be sure that the products will be actually significantly cheaper and affordable and thus

increase access? For instance, could you intervene if you realize that the prices are still too

high and not affordable to countries?

We don’t decide price. Every time they tried to decide a price it was wrong. It went down

with the market and the generic competition. When there is a patent that doesn’t allow that

to happen, we try to remove that barrier and to allow that competition to happen to give a

better price. If we start fixing the price, that’s not going to give you a good price. If I put a

ceiling price, they’ll all charge up to that price. The ceiling price is the originator price

because that price is already available in the market. So if the generics want to sell they have

to sell cheaper than that. Fortunately, the market price competition has brought the ARV

price down significantly.

A tiered pricing approach allows the originator price to be lowered very much and allows the

competition between the generic brands. When competition happens, the generic price goes

down but the originator prices stay the same, that is to say the price in the US stays the

same. That is why we want differentiated pricing structure, to increase the competition and

lower the overall prices.

12. Abderrahim: Actually, all that you have been doing is supposed to be on our behalf, people

living with HIV, our countries! Who gave you the mandate to speak on our behalf?

This is the message we’d like you to bring back to your company, we know that we do not

have time to answer this right now.



13. Sany: If excluded countries want to issue a compulsory license, will you publicly support

these countries? For example, Egypt is one of the rare MENA countries who want access to

Atazanavir because a patent has been granted. If Egypt decides to issue a compulsory license,

will the MPP publicly support us?

14. Rita: I am from Lebanon. I don’t see any difference between my country and other MENA

countries that are included in your license in terms of income or epidemiology. Could you

explain to me the rationale behind our exclusion? Furthermore, with flows of refugees from

Palestine and now Syria, the situation is even worse.

For some of the licenses it is included but for some others there is no patent for Lebanon so

Lebanon would be able to buy from the generic. Because the companies allow the countries

with no patent to buy the product generically, Lebanon can do this. That is the information

that we have (referring to the orange and green slides). In terms of having those for us, my

understanding is that Dolutegravir is a product that is very exciting in terms of its

characteristics, little side-effects and only 50 mg.

The key point is whether or not Lebanon will be able to benefit from the products.

15. Rita: Otherwise, I am really shocked to see that a country such as Palestine, which relies

100% on the international aid, is excluded from your licenses. Do you or your partner

companies consider that the government has the ability to pay?

I’ve looked at the data for West Bank and Palestine and often they are paying the highest

amount for generics and other drugs. I think that this has a lot to do with how the drugs are

transported to them. I don’t think that we are necessarily the right company to talk to about

this. As the MPP we would like to work to figure out how we can help and fix the prices that

they are playing.

16. Mohamed: Just like Rita, I have been really surprised to see that Jordan is the only country

excluded from the pediatric Abacavir license, knowing that we only have a few children on

treatments. Frankly, I can understand that a company defends its commercial interests in a

country. Do you really think that 20 children in Jordan represent a strategic market for ViiV?

I apologize that is my mistake here. I’ll re-look at the slides and send you the slides with the

right data. I couldn’t imagine a country that is only 20 children. We just announced that we

are expanding the countries that are including Abacavir in pediatrics.

17. Fatimata: Excuse me, before M. Burroneanswers; I am really concerned about the

knowledge of people who are negotiating on behalf of our region. M. Burrone, would you be

able to locate Jordan on a map?



In the negotiation, we try to get all the low and middle income countries in. That is the

starting point. Then the company will tell us which country that we can include. We tried to

get Jordan included, that is a given. Is it a commercial market? I can’t believe that any of

these countries are really a commercial market. You should discuss with ViiV about the

specific reasons for this. I really don’t believe that pediatric HIV is a commercial market

anyway. A lot of what they do is really about the precedent; they are trying to set a

precedent.

18. Zahid: I am from Pakistan and personally, I am getting more and more confused. Looking at

your licenses, I don’t understand if I am living in a poor country, in a rich country or in a

middle income country. Is Pakistan a high prevalence country or a low prevalence country?

As sometimes I am in the country and sometimes I am not, I would be grateful if you could

help me out in my ignorance.

Pakistan was in the first license and out of the second license and in the third and out of the

fourth. Sometimes they are included and sometimes they are excluded. The key challenge is

we will try to say to a company, this is who you have included now, and push them to include

Pakistan. But it is a voluntary process so it is ultimately up to the company. Pakistan is

fortunately a country that we have been able to include in most of our licenses, and if it is

not included there are provisions that allow it to buy from generic brands. We are faced with

countries that are increasingly starting to see these countries as commercial markets. That’s

what we’re facing and we’re trying to push back.

19. Zakaria: I am from Morocco and I can understand that Morocco is less poor than Yemen,

Mauritania and Sudan, however, just like Rita, Mohamed and Zahid I am lost. Could you

explain how our countries are considered poor enough to access Abacavir and not poor

enough to access Dolutegravir? Can you explain why Egypt can only access Dolutegravir and

why we Moroccans, Algerians, Tunisians, Lebanese, Jordanians, etc. are excluded? What

does Egypt have different from us apart from the pyramids?

The license for Abacavir is a pediatric license, which means that it is easier to include more

countries in this license. This is not seen as a commercial license as the adult products are.

On the other hand, this is not finished. A license can been modified many times, just because

it is signed does not mean that it is finished. It can be modified in 2 or 3 years. Right now, the

license is publically published and people can reference them and demand why are we not

included? Additionally, a country can demand this and question what is in the license in

order to make the enterprise move and adjust.

20. Heba: What are the Medicines Patent Pool criteria for determining whether a country is

paying royalties or not? For countries that are paying royalties; how did you decide on the

tier? What makes you say that it’s acceptable this way?



For countries in low income status like those in Subsaharan Africa, there are no royalties; we

do not take royalties there. There are 67 countries where there are no royalties and there

are many countries where there is no patent outside of those 67. So then you’re left with a

list of about 15 countries, maybe more, where there are patents. So the challenge was to

convince ViiV to include these countries in the patent. ViiV was saying that their board only

allows those 67 countries in their patent. So then they were saying what can we use as

features to try and get these new countries in. There are two things we can do, the first one

is market fragmentation. We would like to be able to get more data on this. We were saying

that at the very least allow the generic brands to be in the public sector. We also proposed

royalties based on the level of disease. So they said we could have six additional countries

with adjusted royalties and it was very necessary that we convinced them of the success of

this. In the end we settled for the income approach linked with GDP level. The original would

be available for about 400 dollars; the generic brand around 100 dollars and then that will go

down with competition. In these six additional countries, the royalties will only be payable if

the patent is granted.

21. Heba: What do you do with companies with whom you don’t reach an agreement? Do you

denounce them publicly?

No, publically we would never denounce a company that we do not reach an agreement

with. In order to manage this, we use complementary strategies in order to continue to urge

the companies. We cite publically the companies that we work with and those that we do

not work with. We write to every company to negotiate with. If they do not negotiate with

us, we will state that we do not have a license with them.

22. Fathia: During the negotiations, do you have any redlines you can’t go beyond that

determine what is acceptable for your or not? Can you share this?

All of the licenses that we have right now came from negotiations that we’ve had with these

companies. We push the companies to the maximum point in order to obtain everything that

we can for these countries. If there are royalties made at the base of the patents, we work to

lower those as much as we can. After discussing with different companies, there are many

different ways to negotiate this. There are certain things that are absolutely essential to

contain in the negotiations and those are what we are working on right now. The generics

should be able to challenge the patents; there shouldn’t be any no-challenge clauses in the

licenses.

23. Douraidi: Given what has been said, it appears clearly that the Patent Pool is failing to

address the issue of access in MENA and middle income countries more generally, and that

the few results that have been achieved are limited to the least developed countries, which

by the way don’t need a Medicine Patent Pool and can simply use the transition period to

implement TRIPS.



Looking at your slide, it appears clearly that the issue of patents is concentrated in the

middle income countries and until now, you haven’t done anything for most of these

countries. Between us, isn’t that a statement of failure?

I fully share that opinion. About 75% of countries that we are working with concerning

licensing products regarding HIV are voluntary licenses. However, it is necessary that we

work and push the laboratories to commit to our negotiations and give more voluntary

licenses.

24. Sany: We have been hearing that the Patent Pool is considering extending its mandate to

Hepatitis C. Is that true? In Egypt, we have been working closely with the government, on

invalidating the patent and on developing the local production. We really would not like to

see the MPP jumping with a voluntary license which we believe won’t bring the needed

competition leading to significant decrease of prices and increasing access.

For the moment we only have the mandate to work with HIV. We have been asked by

UNITAID to explore the options and what we could do with Hepatitis C. This is interesting

what you are asking me. No country is worse because of a patent license, and I want to make

that point very strongly. I don’t think that there is patent in Jordan for Abacavir, going back

to that, we can recertify the data to make sure. With Hepatitis C, we are in a phase where

there is a lot happening. From the MPP perspective, some people think it would be great and

other think it would be the worst thing. Right now we won’t do Hepatitis C unless there is a

full feasibility study that shows us that it would be a successful process.

25. Khaled: I am from Sudan. Even if my country has been included in the previous licenses, I feel

in solidarity with my colleagues. Given all of what has been said, can you tell us how you are

planning to deal with the MENA region in the future?

There is no license right now. Because there no patent in India, generics can produce in India

and sell at a cheaper price. We are trying to expand this to other countries to ensure the

availability of the drugs in other countries. That’s the context in which we’re trying to get as

many countries in the MENA region included. I think it would be great if we can consider

strategies to tell these companies that these generics are important and that they need to be

able to be sold.



1. Khammas: So far, Abacavir has been used very little in our region because of the fear of

prescribers of hypersensibility reaction. Question in two parts: Do you have studies/data on

the frequency of such mutation in the MENA region? Or in any other resource limited

country? As part of your promotion for access to Abacavir, what efforts do you do to make

the hypersensibility test available?

We work with diagnostic companies so we make sure that HLA testing is available on request

by physicians. The test is an expensive test but we are very interested in working with

countries that are interested in launching the product and make in available for those who

need it. Regarding the affordability, for example, in Kenya the HLA test is not available right

now in the public sector due to cost issues. So the patient that would go on this testing is

outside of the public sector. At the moment the countries I have information on are Saudi

Arabia and Turkey because they are very interested in the product so we are working to

make it available to them. Our commitment is when we launch the product in the country,

the test is available. The testing still needs to be carefully monitored.

2. Khammas: WHO just added ABC as a potential interesting 1st line for pediatric use. Do you

have any data on the risks of reaction to hypersensibility for children? Is the hypersensibility

test compulsory/recommended before the treatment initiation? And if so, how do we make

it available in resource-limited countries, especially as the demand is going to increase

following to the new guidelines?

As a company, we recommend the use of the test but in reality the governments decided

where to use the test. The patient can decide not to pay for the test and instead immediately

start treatment but we recommend the initial testing of the patient before treatment is

given. This is then the decision of the prescribing physician and the government.

Commercially, the test is recommended for children under 10 years of age and there is an

increasing demand for the drug. The rate of HSR in children and pediatrics is very low, not

nearly the same as adults. My information is that there is no request from the WHO to

supply children with the drugs. Thus commercially they do not specifically supply pediatric

drugs but they include an enormous amount of information. This excess of information will

give you some comfort as a clinician It is recognized very quickly. Where it is commercial, we

Meeting with ViiV healthcare

ARVs: Production & Pipeline



are very committed to working with the governments to ensure that everything goes well, by

setting up reference labs and working very closely with the government. We signed an

agreement with Clinton Health and Mylan Pharmaceuticals. . Abacavir is and will be a very

good drug for pediatric use, it is very dispersable and taste masked. In 2013, Abacavir was for

ten year olds, we knew that other medications were toxic for children. We used Abacavir 3TC

30 mg and 60 mg, we made it fully dispersable and we taste masked it. The last few months

we have been working in partnership with them in order to ensure the highest quality of this

pediatric drug. Mylan filed a pre-qualification with WHO last year and we are in the process

of answering their questions now. There is not a lack of commitment and we aim to make

this drug affordable.

3. Othman: Could you explain to us what is the therapeutic value added of Maraviroc for

patient in virological treatment failure in comparison to competitor products such as

Raltegravir or Darunavir? How do you analyze the fact that you do not have the same

commercial success with Maraviroc than Merck and Janssen and Raltegravir and Darunavir?

There is one observational study that saw an increase in cardiovascular events. It was an

observational study where all the confounding factors were not taken into consideration.

The other risk factors were not accounted for. Because of this, we and the FDA took this very

seriously and looked to see if we had a signal in our clinical trial. We assessed the signal of

cardiovascular side effects in our clinical trials. The analysis done by the FDA concluded that

there were no identifiable risk factors that affected the cardiovascular system. Several

international guidelines changed the importance of Caivexor for the initiation of ARV

therapy.

4. Othman: At what stage are the clinical trials for Drug 744, including on the “long action”

form (1 injection per month)? Will it be more for treatment? Or prep?

For this we work in partnership with other companies. The trials will start soon and this is

very early for a study this small. The study includes young women in particular there is an

epidemic for young women in Africa plus prevention development. The study is not

technically in our hands, we have passed on the study to our partner at the clinical site in

South Africa. There is only one drug in the prevention study that is not shared in the

partnership.



5. Zahid: In which countries have you registered your product? As for the countries where you

have not registered your product, what are the reasons for this?

We as a company are committed to submit the dossier in every country of the world,

everywhere. The main countries in North Africa need European approval (was approved in

January of this year) and these will be submitted in three waves as we do not have the

capacity to do it all at once. What we committed with DTG is to bring to all countries with a

regulatory authority. We have committed to filing these dossiers in March, June and

September of 2014. DTG needs to be registered in all countries with a regulatory body in

order for the patent to be successful. The other countries we hope to register in North Africa

include Algeria, Egypt, Jordan, Lebanon, Mauritania, Morocco, Tunisia and Pakistan. We are

having trouble with the regulatory capacity in Palestine, Sudan and South Sudan. I have

information that I am not comfortable sharing, but there are three countries where the

dossiers have already been filed. We cannot share a more precise list at the moment of the

countries we have already registered in and those that are in the process due to legal issues.

I would rather come back with a full list concerning the countries and DTG as well as ABC.

6. Souhaila: A few months ago, you met with the Ministry of Health of several countries in the

Maghreb (in Morocco at the end of 2013). What was the purpose of these visits? Is there any

link with the registration/marketing of DTG and pediatric ABC? What has come of these

meetings?

We came to Morocco over a year ago and participated in a series of informal meetings to

discuss the clinical trial as well as how to make the drug accessible to MENA countries. The

HLA trial is already ongoing in Morocco in comparison with everywhere else in North Africa,

where it is new. We have colleagues that are fully dedicated to this region that spend time

visiting mainly physicians to understand what they need. We felt that the Moroccan

government had a strong interest in the drug DTG. Overall I was really impressed by this

country to make antiretroviral medications available.

7. Fatiha: In some countries, you have filed patent applications. Do you systematically register

in countries where you file patent applications? As you know, because a patent exists, this

can prevent the appearance of a generic brand on the market. We find it unacceptable to

block a generic brand when the patented medication is not accessible!

Registration



We need to first complete our clinical trials in order to demonstrate that DTG is as safe as

current drugs used. There is no direct link between whether the drug is registered and or

whether it has a patent thus we have committed to registering the drug everywhere. For

example, Algeria was one of the first countries that we registered in.

8. Fatimata: What will your marketing strategy for DTG be in resource limited countries,

including those from the MENA region? Will you position DTG as a first line to compete with

Tenofovir-based 1st lines (as you do in rich countries), which would imply a considerable

effort on prices (as the TDF-based regiment is off-patent), or will you rather place DTG as a

part of 2nd and 3rd line regiments?

The way in which the drugs are positioned depends on where drugs are approved and which

indications we get. In Europe and North America we have indications with both the naïve and

experienced groups. Commercially, one aims to sell to those markets or those indications

where there is a need for the drug, whether naïve or experienced. The drugs that are

restricted to 2nd and 3rd line regiments are often those that are more expensive and difficult

to make. Very often that is because of the volumes of those drugs, they are produced at such

low volumes. DTG is 50 mg and my expectation is that the price will be affordable in naïve

and experienced groups. For example, we hope to communicate an access price in Kenya in

the next month or so. The pricing of these drugs depends on the specific country taking into

account the international region (Latin America, North Africa, Europe and Asia Pacific), the

size of the country, GDP and GNI, the size of the epidemic. We need to price our products at

a competitive level; if not there is no sense in producing them.



9. Fatimata: In the countries covered by the MPP licenses (Egypt, Yemen, Mauritania and

Sudan), who is going to register? Will ViiV do it or will the generic producers have to do it?

Will you work with the generic producer to make sure that the product will be effectively

registered?

We will register in all countries to enable the generic companies to cross reference our files. I

don’t know the current registration status in this part of the world but I will come back to

this. But the goal to have this dossier registered in all countries where this is possible. We are

working to make the available in one year as the average availability is seven to ten years.

10. Othman: In countries where you don’t have any patent, will you use data exclusivity to

prevent the registration of the generic version?

In the past companies have been slow to register with no sales and no pressure to register.

What we are saying is that we want to register this in every single country in this room that

has never been done before. We only got FDA approval in October of last year and the day

we did that we signed a voluntary license with Orabindel. Additionally, we only got European

Union approval in January of this year, and here we are putting dossiers in countries only 5

months later. The company is fully committed to registering DTG in every country.

The dossier has such a robust data package and file that we barely have any questions on the

regulatory authority so the approval is coming faster in these countries. We are trying to

make it as efficient as we can.

11. Souhaila: What are the countries where you have filed/granted patents vis-à-vis DTG,

specifically Tunisia?

Any country with a patent is linked with ViiV healthcare. Given the license, we will compete

globally in patented and non-patented countries. With generic companies and tiered

structures we will carry out the same policy. We are not going to walk away from this

commitment; we are committed to the supply of these products at a competitive price.

Ultimately, this will help medically and reputationally for ViiV healthcare.

12. Abdelrahim: What is your patent policy in MENA? Will you file patents everywhere or only in

several countries? What will be your criteria?

Patents & Intellectual Property



You would expect a pharmaceutical company to patent everywhere but they do not. I don’t

know the reason why this is not true but I can try to find out and get back to you with a

concrete answer. I know that it has to do with intellectual property rights. My guess is that

whoever made the decision probably thought that HIV wasn’t a problem in this region and

decided commercially they couldn’t make much revenue.

13. Mohamed: Looking at the patent landscape, we have noticed that you use a lot of

evergreening practice: patents on the original compound, the hemisulfate salt, the pediatric

use and on various combinations with older drugs. This process only aims to extend your

monopoly in order to delay legitimate generic competition. Don’t you find it immoral in

resource-limited countries such as ours?

There is a difference in the way that ViiV is trying to operate. From the perspective of the

company, the patent is valid. The morality of multiple combinations of the drug is much

more specific and individual to each brand and not contained in the patent that ViiV

healthcare holds.

14. Zakaria: If an excluded country from your DTG license (i.e. Morocco or Algeria) issues a

compulsory license, how would you react? Will you pressure the country or respect the right

of this country to use the TRIPS flexibilities?

Any country with a patent and grants a compulsory license is discussed on a case-by-case

basis. There are some good examples; Indonesia issued a compulsory license with Tenoflevir

as a political message. We would need to discuss the reasons for giving Morocco a

compulsory license. With the Ministry of Health we would need to discuss the effect of DTG

on the country and what we can do about it. It is a difficult position for countries with

unstable relationships linked with their governing bodies. Even if the country expresses

extreme interest in the drug, the government could have no intention of following through

and supporting access to the drug. My experience is that we would also discuss with CAB or

ITCP in order to better ensure the support of the drug. If we disagree with access policies, we

may take action with the country but again, that is decided on a country-by-country basis.

There have been three or four countries where compulsory license have been issued,

included Brazil and Indonesia. TRIPS flexibility says that if you do compulsory licenses you

need to negotiate, each country can set the price of the drugs and whether if they are set on

the market or not.

15. Mohamed: Linked with question 14, we heard that two years ago you sued PWHIV in Ukraine

(all Ukrainian networks of PLWHIV for introducing a generic version of Abacavir and

breaching your intellectual property rights)? If we do the same, are you going to sue us?

My personal view is that will not happen with ViiV healthcare. There must have been a clear

problem in Ukraine. It is highly unlikely that we would launch litigation for pediatric

medicines.



16. Regarding the presentation, can you go back to the criteria for the access strategy?

You’re asking us to give you the criteria that we are currently defining. I can’t share those

with you specifically right now as they are still being finalized. In general it will be based on

the GDP, GNI (humanitarian index), and size of the epidemic, size of the country and the

income level of the country. There are some missing factors and that is why there is a gap in

pricing in your region which we are trying to work out right now.

17. Othman: Patent pool license: Why did you negotiate two different licenses on ABC (with the

MPP)? One is wider with respect to pediatrics and the other more limited for adults? Outside

of the patent pool licenses, are you considering signing parallel voluntary licenses with the

generic producers (outside the MPP)?

The voluntary licensing policy has been in place for 13 years. MPP is very important as well,

they signed an agreement to accelerate the accessibility of DTG. The policy now exists so that

we will not seek to sign any voluntary license outside the patent pool. Additional licenses will

destroy the value of the patent pool and we are very adamant that this does not happen.

There will be an announcement of two or three other licenses but no others outside of those.

We signed an agreement with Orabindel giving them commercial license, meaning that it will

probably be one of the first companies with the drug on the market.

18. Sany: How do you explain that Gilead, the first firm who made the highest profits on HIV,

covers 112 countries with licenses while you only cover 73 countries?

For us, it is not solely the number of countries but the coverage. ViiV covers almost the same

area as Gilead but we are trying to get away from listing the number of countries and gear

towards coverage. Just because a country does not have a license does not mean that it has

denied access. The two should not be compared as Gilead is a totally different operating

model that takes royalties.

19. Heba: On what criteria have you decided on the included and excluded countries for these

licenses? Could you explain to us why a country such as Egypt who has the same level of

income as Morocco, Algeria or Tunisia is included and not the others?

When the voluntary licensing was created in 2001 they focused on developing countries.

These definitions were given by the World Bank and the UN not just based on geography and

boundaries but by also including low income countries. When we managed to get into the

MPP we added six additional countries that we thought that we could seriously make an

impact in. This depends on a vast array of conditions. How do you generate commercial

revenue as well as increase the availability of the drug?



This is the big question in the public health sphere. We don’t include some of these countries

because it is faster as ViiV healthcare. We only charge a royalty where the patent is approved

or granted, Egypt is the exception. The size of the epidemic in Egypt is large but with no good

commercial presence in the country, working with the patent pool in Egypt could be very

successful. We wanted to see the impact in Egypt so that is why it is included. We cannot

include some of the countries because of certain regions of the world, such as the case with

Ukraine and Russia. Directed by my legal colleagues, I am not allowed to disclose patent

information or my head will be on the block as that would be a breach of my employee

contract.

20. Mohamed: We are surprised to see that on the pediatric licenses the only country excluded

from the MENA region for Abacavir is Jordan, and for Dolutegravir, Jordan and Libya. How do

you explain these exclusions?

We will take this message back with us. That seems to be an oversight. The impact of

reference pricing leads to the exclusion of certain countries such as Mexico or Russia but I

agree, the exclusion of Jordan makes no sense.

21. Rita: Given the socio-economical and political context, we are shocked that a country such as

Palestine is excluded from your licenses. Furthermore, this country mostly relies on the

international aid and the number of PLWHIV is weak in this country. Could you explain to us

why this is?

In terms of patents and company policy, we are not here as a commercial wall that is not

listening to you. Which country cannot pay the price that we have negotiated? If you can give

me definite details I can take that straight to the CEO. I understand what you are saying that

there is no government in Lebanon to sign or help so if you can write to me and help me

understand who to provide the drugs to and the other additional barriers to access that

would be extremely useful. I need to hear that there are problems in Lebanon with influx and

refugees to fill in the blanks about what/who/where/how we can help concerning these

drugs.

22. Douraidi: For countries excluded from the licenses, what is your price policy? What are the

criteria to define prices? Will there be a unique price for all countries of the region, or will

the prices differ in each country?

This is information they are currently finalizing and defining more specifically to explain the

parameters by which a country prices a product. In general, we look at GDP, GNI, governing

bodies, the size of the country, the size of the epidemic and other competitive drugs. The

price is set by the market and by the countries, is it a national tender? It all depends on the

specifics of the country. We want to act as a transparent mechanism on the way in which

things are priced the way they are.



23. Douraidi: Could you please define the “country commitment”?

We are not pricing by region but by country. There are private sector prices, public sector

prices and NGO prices. There are certain challenges with each country that need to be sorted

out. We are trying to work with the civil society and government of each country to have

differential pricing strategy. This has not yet been finalized but when it is, the information

will be available to you.

24. M. Dadsi: Now that the price of Dolutegravir is public in the UK and in the US (between

10,000 and 14,000 dollars paid per year in the US), what will the price of DTG be in MENA

countries?

Wholesale prices are what you would normally find in North America. The way companies

tend to work is they generate commercial income from North America or Europe then North

Africa and South America. After that, the region with the lowest pricing in the lowest income

regions. Thus in this area, the price will be between the lowest price in Africa and the highest

price in North America, and from my perspective it will be at the lower end. The UK is coming

in at a price that is the same as the previous products and the price will ultimately be set by

the governments but it still needs to be affordable. I have no price answer now but with

registration coming in the next few months we will see a scale of pricing. We will not price

highly as we are working to establish a balance between commercial and public access. I

cannot comment on the prices of these countries yet without the approval of the

governments in the countries. Morocco will probably have a higher price than Kenya but this

depends on the generic brands that already exist. The prices are set by the market and the

government. We cannot share the prices yet because none of the countries have national

guidelines for the drugs but in the next coming months we will see the Brazil approval and

the Kenya approval.



First MENA-CAB, Casablanca, 28 June-1 July 2014

MENA CAB Report

Healthcare

Transcript of MENA CAB Report