Image credit: The New Yorker
The is a meeting memo from the joint event in parliament of the Africa APPG and Global Health APPG on the 19th January 2015.
An audio recording of the event is available here.
The Ebola virus was discovered in 1976 but despite this, no vaccine for the disease is yet available, although GSK have now begun clinical trials for their vaccine in the countries affected. It has been suggested that there has been a lack of will to produce a vaccine before the recent outbreak largely due to Ebola outbreaks tending to occur in poorer countries and that consequently there is limited commercial viability and scope for profit.
This raises a quandary of questions about the interaction between market economics and the pharmaceutical sector that need to be analysed, understood and re-worked into a modern model that responds to the needs of the global population.
This panel debate sought to consider the following:
- How can research and development into emerging infectious diseases be better incentivised and what role is there is for pharmaceuticals?
- What are the main barriers that have prevented earlier development of treatment and how can they be overcome?
- What actions need to be taken to support an African pharmaceutical industry?
- What needs to be done to redesign the current business model and what would that model look like?
Chair: Meg Hillier MP
Dr Egeruan Babatunde Imoukhuede, Clinical Project Manager and Vaccinologist, The Jenner Institute
Dr Imoukhuede's presentation slides are available here.
Dr Imoukhuede argued that the main barriers to prevention of vaccines for diseases such as Ebola was due larger to the high costs of developing a new vaccine and the small profit margins for pharmaceutical companies. He added that this coupled a lack of technical transfer to the African pharmaceutical industry and intellectual property issues also presented barriers.
He believes these barriers can be overcome by political will for targeted interventions such as tax incentives for pharmaceuticals and prioritising pooled funding for regional outbreaks of pathogens for the public good. He called for better technology by transfer from multi-national pharmaceutical companies and between academics.
Regarding support for an African pharmaceutical industry he said better regional coordination and collaboration between research and pharmaceutical organisations was needed together with capacity building in engineering and whilst investing in education in technical skills.
In conclusion, he advocated for a regionally driven strategy towards developing vaccines for diseases such as Ebola but that this regionally driven approach should be coordinated by WHO. He suggested that any international collaboration strategy should include the use of stockpiles of vaccines for specific regional outbreak pathogens (vaccines developed to proof of concept) so that during an outbreak they can go straight to trials. He said that the process should be ongoing with the constant development of new vaccines for such diseases.
Mr Jon Pender, Vice President, Government Affairs, GlaxoSmithKline
Mr Pender challenged the assertion that the lack of investment in a vaccine was due to commercial reasons and argued that it was predominately due to the fact that developing a vaccine before the latest outbreak was not a priority the international health community due to the small scale of earlier outbreaks. He explained that the disease burden of Ebola compared to diseases such as Malaria or Aids was small, with previous outbreaks being sporadic and small and contained through isolation techniques. He quoted that there were 24,000 cases of Malaria each hour, which is more than the cases for the current outbreak.
He drew attention to the fact that Ebola was also not at priority NTD for WHO, the US FDA Priority Review, on the G Finder report and not covered by the Access to Medicines Index. He called for more clarity for the industry on what the world wants and needs and where R&D efforts should be focused. He sited the London Declaration as an example of the industry stepping up to tackle NTDs when there is clarity over priorities and collaboration in forms such as Product Development Partnerships (PDPs).
Regarding incentives, he said cash incentives such as £200-300 million were not the main pull for large pharmaceutical companies and that bio-tech start-ups would be more interested in these sums. He argued the main incentive for pharmaceuticals was not money but reputational gain to be had from working on NTDs and that such incentives need to be better targeted.
As for developing the African pharmaceutical industry, he said that African Governments needed to prioritise health spending more in their budgets and move towards the 15% Abuja target along with streamlining of regulations, tackling corruption, transparency and regional integration to allow easier trade and movement of workers.
On a new business model, he said there should be dual objectives of both innovation and access through collaboration between large pharmaceuticals and external partners.
He concluded that there was a 'silver lining' to the Ebola outbreak with regards to the SDGs. He said Ebola had demonstrated that if there is the political will and clarity over what is needed, the development of vaccines and medicines can be accelerated with regulatory authorities approving pre-trial protocols within 48 hours as opposed to 48 weeks.
Dr. Adrian Thomas, Vice President of Global Market Access & Head of Global Public Health, Janssen Pharmaceutical Companies of Johnson & Johnson
Dr Thomas said that developing vaccines for diseases such as Ebola takes consistent year on year investment coupled with broad based academic scientific research and biotech start-up companies involved in the investment. In addition, adjacent technologies and delivery systems need to be in place to receive new technologies.
He argued that the biggest challenge is always the science and the key question commercially is what is the strength of the science and the ability as a corporation to bring together the expertise to make advances. He said the second commercial question is to what extent is there a reward for innovation or a willingness to risk share in bringing the science forward.
Thirdly, is the consideration of whether the medicine will actually reach the people that need it- the systems need to be in place to do this and pharmaceutical companies need to work better with the international community and NGOs in understanding what is needed.
On the business model, he argued that the Ebola outbreak had demonstrated that within 4-5 months they were able to get regulatory flexibility, alternate financing models in the US and Europe with diagnostics companies also getting involved and argued that as such the current business model does work. He said this was demonstrated through the co-investment R&D to de-risk investment, multi-lateral collaboration around the ability to resource public health infrastructure in affected countries and the deployment of thousands of international aid workers. He said the model is there and works but needs to be expanded.
Dr Thomas said that multi-national pharmaceutical industry play an essential role in advancing science and health in an innovative way through taking long-term 20-30 year risks to bring a new drug to the market. He said that it often takes 15 years of research to prove the safety and effectiveness of a drug and that in return for that, the pharma companies look for a sustainable reward. He added some companies do this for reputation, others for the science or alternative incentives and some for direct financial reward and that the spectrum of incentives needs to be fully understood.
He finished by saying he thought Ebola was important but then compared it to the 130 million people with Hepatitis C, 200 million with Hepatitis B (for which there are vaccines) and half a billion people who die each year from multi drug resistant TB. He concluded that the focus needs to be on how best to bring stakeholders together for a cause.
Dr. Adesina Iluyemi PhD, Executive Board Member, NEPAD Council
Dr Iluyemi said that Ebola had finally gone global after spending 40 years within the confines of Africa which has shone a spotlight on NTDs in Africa generally.
He welcomed that GAVI had given £300 million to fast-tracking the development of a vaccine and said that the lack of R&D into diseases such as Ebola was a problem and it needed to be investigated. He pressed the importance of involving African countries to collaborate and encourage investment and facilitate technology transfer.
Regarding barriers to development, he said there had been reticence of behalf of African Governments and that despite that Ebola was discovered 40 years ago he said there was no research or development into the disease happening in any African countries. He also criticised the international front for also being reticent and for only spending money into a problem that is 'yours'.
He said there should be a link between global health diseases and national security and that this element is often missing. He drew attention to the fact that prior to the recent outbreak, the only drug developed was ZMapp from US defence funding but that funding was withdrawn for ZMapp, which is why stocks were low. He asked whether national security of wellbeing could be a driver for investment into drug development for pandemics.
He added that previous outbreaks were not publicised and information never got out due to a lack of comprehensive surveillance systems which prevented investment into drugs for Ebola. Information about the previous outbreaks never got out.
Regarding the African pharmaceutical industry, he said it is currently none existent but that there are initiatives at the continental level- the African Network for Drugs and Diagnostics Innovation (ANDi) is network of research institutes in Africa working to develop drugs and diagnostic technology for diseases of economic importance to Africa. He suggested that any R&D in Africa should look to support this.
Another initiative he mentioned is the Pharmaceutical Manufacturing Plan for Africa- this is an initiative from the African Union which is backed by UNIDO (United Nations Industrial Development Organisation). Its aim is to encourage investment into a pharmaceutical manufacturing base in Africa and understanding how this can be developed.
He finished by drawing attention to the long-term economic impact of the Ebola outbreak on growth in African countries. He highlighted a World Bank report which shows that growth has slowed and as such the long-term impact need to be seriously considered.
Baroness Northover, Parliamentary Under Secretary of State for DFID
The Baroness focused on the challenges that surround the development of vaccines more generally.
She said that the Ebola outbreak was unprecedented and served as a reminder that keeping a collective focus on global health is vital. Latest modelling work shows that safe and effective vaccines can have a significant impact on controlling the Ebola epidemic in any scenario.
She reported that the UK Government has been driving forward the manufacturing, improvement and delivery of a vaccine by early this year and compared the progress to the difficulties in developing an HIV vaccine.
To improve responses to outbreaks of infectious diseases in the future, she said that it was important to pro-actively identify potential diseases and develop technologies such as vaccines and treatments to address them.
She said that the Ebola outbreak demonstrated that there are inadequate market incentives to develop therapies and vaccines for global health threats until the emergencies occur. Between 1975 and 2000 the world saw just 13 new drugs for diseases of poverty, which was about 1% of the total new drugs developed globally.
She acknowledged that bringing a new drug to market was very costly and risky and that so-called diseases 'of the poor' have been badly neglected in research efforts. She argued that if we add to that the extremely low profit margins associated with making these drugs and vaccines it is not difficult to see why the development of affordable and accessible treatments has not been prioritised in the way that it should have been. She said this was why research into Ebola was only speeded up after the current outbreak has spread.
To accelerate the roll out of safe, effective Ebola vaccines she said we need rapidly to deliver clinical trials of the promising candidates, resolve intellectual property issues, scale up production, put in place delivery capacity and manage the increased liability risks, whilst securing finance for all these aspects.
She acknowledged the role that PDPs (Product Development Partnerships) had played in changing the drugs and vaccine development situation, arguing that they harness the best of the private sector so it is channelled for the public good. She said PDPs acted like virtual pharmaceutical companies where a small group of staff coordinate the development of a new range of drugs and technologies whilst drawing on the strengths of academia and industry with expertise in accessing uptake.
She added that since the introduction of PDPs, 10 new technologies have been brought to market and there are over 350 candidates in the pipeline including 90 drug and vaccine candidates. She added that the Government, along with the Gates Foundation continues to invest in PDPs and support the role in global health research.
The Minister concluded that underpinning the two pillars of 'better preparedness' and 'improved mechanisms' is the importance of investing in developing countries own capacity to provide access to essential medicines. The stronger the systems to deliver essential health technologies, the better countries will be able to cope with health threats and drew comparisons between Nigeria and Sierra Leone's reaction to the outbreak.
She added that the UK is committed to working with pharmaceutical companies and the private sector to tackle the challenges of developing vaccines.
Followed by open Q&A
- Founder & CEO PharmAfra raised the issue of difficulties that African pharmaceutical companies have in getting WHO certification for new drugs and hygiene equipment and asked how they can be better supported given that they are often closer to the patients.
The Baroness explained that most importantly was ensuring that the necessary clinical trials were gone through and that the WHO play a leading role in ensuring that the proper processes are followed but moved along quickly. She also warned of the dangers of focusing on speed over the safety of those that are taking part in the trials.
- Robtel Pailey, Researcher at SOAS- made the point that when talking about statistics such as 20,000 deaths from Ebola compared to over 20,000 deaths from other diseases. She asked why the conversation was always about a zero-sum game (either/or) and that 20,000 lives within 40 years still matters.
Dr Adrian Thomas acknowledged the point that every life does matter and then went on to say that he didn't feel that burial practices (as previously suggested by other speakers) were the real issue and that in order to save lives, better health infrastructure was the key. He suggested that the reason people stayed away from the isolation centres at the start was due to fear and risk of catching Ebola and only went once there were effective rehydration and shock treatments available. As such fatality rates in these centres have dropped from 90% to 60-40%.
Jon Pender also agreed that every life lost was a personal tragedy but reiterated that the focus of the discussion was on economics. He said that unfortunately, in this area they do operate in a zero-sum game and that there are a huge amount of unmet medical needs and as such their needs to be some prioritisation. He suggested that nobody at the time was prioritising Ebola and agreed it was unfortunate that it takes an outbreak such as the present before any resources are put into it. He explained there were 150 people at GSK working on Ebola day and night and as such there were not enough resources to focus on everything at once.
Baroness Hayman commented that prioritisation had to be spoken about in addition to numbers. She focused of maternal mortality and said that in the UK the ratio was 8:100,000 compared with 110:100,000 in Sierra Leone before the Ebola outbreak. With regards to DFID resources, she said that they had to prioritise and that the poverty and lack of health systems was the most important thing to address.
- Elizabeth Blunt, IRIN news (who subsequently wrote an article on the event) challenged the pharmaceutical representatives to explain what their incentives were if they were not purely about profit and how to best 'pull their strings'.
Jon Pender of GSK said that it terms of incentives, the first thing would be to have guidance and clarity over what the world wants prioritised, saying 'NTDs', is not enough and there needs to be some specificity about what treatment is needed and what the target profile is.
He added that these were 'diseases of poverty' and as such they were never going to make money from such diseases and said that if you look at the market based incentives for these diseases it is probably counter-productive. He said that they want to be able to invest in these diseases but that it needs to be done in a sustainable way, he says they are not looking to make money from them but that they also don't want to lose any money either. He added that PDPs had been really relevant in changing the landscape as they allow the sharing of cost and risk.
- Lord Lea asked about the intellectual property issues and what they were.
The Minister explained that when trying to come up with new drugs or vaccines as speedily as possible there may be times when one organisation is taking forward another's research. As such it is important that intellectual property rules in this area allow for it to be moved forward quickly.
Jon Pender added that he believed there was no IP issues and claimed that nobody was trying to protect their own findings and that everyone was working for the public good.
- A representative from Unite for West Africa said there was a general lack of information about the availability of vaccines and the work being done it that area. He asked about DFID's work with the Sierra Leonean Government to ensure that the correct information is getting out to the general population.
The Minister said that DFID had been engaging at the community level through using anthropologists to better understand the society they are working with i.e. burial rights but did not directly address the question of working with the Sierra Leone Government on this.
Jon Pender commented that the international community had let the people of West Africa down in terms of the speed in which it responded, partly because the WHO was caught unawares and that there had never been Ebola in these countries before. He said it took 3 months to identify what the disease was.
- Dorcus Boateng, Public Health Nurse working in Zimbabwe, asked what support the UK Government could offer to galvanise the diaspora and facilitate them in assisting with the Ebola crisis.
The Minister agreed that more is needed to be done to engage properly with such groups.
- Baroness Masham took the opportunity to raise the plight of the Ebola orphans and asked who would take responsibility for them.
Jon Pender commented that he didn't know who would be doing this, but commented that GSK were working very closely with Save the Children in the three affected countries and was providing £300,000 to help their work in this area.
Mukesh Kapila, Prof of Global Health at University of Manchester who had just returned from Liberia and Sierra Leone made three points-
- He drew attention to the fact that the bulk of the frontline Ebola work is being done by local healthcare workers and argued that even if we doubled efforts from outside, there is nothing more we could do than they haven't already done themselves.
- His second point was that he didn't think the vaccine had any role to play in combatting the current epidemic and was concerned that due to the hurry there would be a 'half-baked' vaccine rolled out, further he said there was competition on the ground and confusion about protocol, including rumours about clinical human trials for untested vaccines.
- Thirdly, he said that even though 20,000 people was a lot, 20,000 people die of malaria each week and said that as such there was no doubt from a clinical perspective what was a high priority. He added that more people in Sierra Leone were dying from maternity related issues and malaria because hospitals have closed down due to the outbreak. He added that the epidemic was causing excess mortalities through other causes and that it needed to be put into perspective.
Jon Pender commented on the ethical nature of the question regarding the rapid development of vaccines. He confirmed that GSK would be going into phase 3 trials of 30,000 people or so very shortly in the countries affected on a very accelerated programme. He added that they would like front-line health workers to be involved in that to allow them protection and to help prove whether it works or not. He revealed that GSK were working closely with the WHO and other bodies to ensure that the protocols are appropriate and mitigated.
- Richard Dowden, Royal African Society made the point that if Ebola was not brought under control, it's knock-on effects on health more broadly in the region could be devastating. He asked the pharmaceutical companies what percentage of profits go into research and what percentage of that research goes into diseases such as Ebola and also things less important, i.e. slimming etc.
Jon Pender responded that he didn't have the percentage figures to hand but said that it would be a very small percentage. He took the opportunity to mention that GSK had dedicated a research centre in Spain to diseases in the developing world which operates on a no-profit, no-loss basis (working on diseases such as Malaria, Leishmaniasis, sleeping sickness etc).
He added most deaths in the world are in fact from non-communicable diseases and as such they had also set up an open lab to work on these. He agreed that they needed to make sure they were working to address the needs of the African populations with regards to such diseases.
- Representatives from the Gates Foundation said that bearing in mind the recent reports that the disease is waning, how does the international community ensure that there is political will to leverage and capitalise on the resources, the learning and the platforms that have been created for research so that they can be applied to other areas? How can the accelerated processes used in this epidemic be institutionalised to get the research done more effectively as different stakeholders coming together on investment, coordination, regulatory harmonisation and supporting the African pharmaceutical industry also?
Dr Imoukhuede said that if there was political will it could be done, he said that the problem needs to be recognised regionally and that it needs to be tackled from within. He said that with regards to the pharmaceutical companies needing to know what is wanted, this should come directly from the regions affected by such diseases.
Jon Pender agreed that it was important to capitalise on the lessons from the outbreak and that they don't just get forgotten once the outbreak is under control.
- A representative from the Young Fabiens asked the pharmaceutical companies whether they had done any anthropological research into patient health seeking behaviours in accessing healthcare and whether this could feed into future processes.
Dr Iluyemi said that Africa had been studied very deeply from an anthropological perspective and that this body of literature needs to be linked to how behaviour with regards to health can be changed. He called for more funding in this area and for better education with regards to healthcare.
Dr Thomas of Janssen added that more funding was needed for health surveillance and feedback. He said that the pharmaceutical industry did not have a great understanding as they were not on the ground, but try to engage with NGOs that do in order to understand how best to interact.
Meg Hillier MP closed the event and drew attention to the soon to be published Public Accounts Committee report on the UK's response in Sierra Leone.
An audio recording of the event is available here.