The Chairperson
Members of the Executive Committee
Esteemed visitors from the Southern African Development Community (SADC) Sub–Region
Ladies and gentlemen
It is an honour and privilege to participate in this important congress. It is a special pleasure as the theme “the science of our times” is very relevant at this time in our country and in fact globally. I am therefore hoping that the outcome of your deliberations will identify implementable innovative solutions to current and emerging challenges facing healthcare. In 1939, Bertolt Brecht said, “The aim of science is not to open the door to infinite wisdom, but to set a limit to infinite error.” This is true, seventy years later. I am pleased to note from your programme that scientific enquiry will be the norm.
Our country is faced with a triple burden of disease, communicable diseases including HIV and AIDS and TB, non-communicable diseases and violence and injuries. Emerging new conditions like H1N1 and extensively drug resistant TB add to this burden. Coupled with this are unacceptable levels of unemployment and poverty, as the statistics released by Statistics of South Africa last week indicate. Poverty impacts directly on social determinants of health. We are unlikely to meet some of the Millennium Development Goals (MDGs) by 2015.
The situation is further aggravated by the global economic meltdown. Does this mean we must moan and despair? Must we throw our hands up and accept defeat? Allow me to say very emphatically no. Access to healthcare and essential medicines is a human right.
Last year we celebrated the 30th anniversary of the Alma-Ata Declaration which not only advocated for the strengthening of health systems through the primary care approach but also:
* Called for equity and social justice
* Emphasised the importance of prevention
* Acknowledged the importance of the social determinants of health and
* Advanced the notion of expenditure on health as an investment rather than consumption.
These principles still hold true. Health for all and social justice imply access for rich and poor, rural, peri-urban and urban citizens, developed and developing countries. Illness is not invited into anybody’s home, nor can it be can it be wished away. It often strikes at the most inopportune moment. Our democratic principles, our core values of Ubuntu, our commitment to Batho Pele principles imply that every citizen must be treated with dignity and in the case of medicines, must have access to essential medicines.
It is very easy to become insensitive to injustice and inequity. It has become normal to many of us to see people scavenging in rubbish bins on refuse collection days in our suburbs. It has become normal to us to see people queuing for hours on end for their medicines at our public health hospital pharmacies. It has become normal in some instances for some patients not to access all the medicines they require. It is indeed a sad state of affairs. Is it not time our professionalism is revived? Professionalism is about caring, responsibility, accountability, courage and discipline.
Given the challenges I have cited, must we not think creatively? Should we not pool our combined resources, strengths and expertise to deliver services equitably? What innovation can we bring to the table to improve efficiencies and affordability? What can we offer to ensure equity and social justice?
Chairperson allow me to state that it is however not all doom and gloom. The government is committed to addressing four key strategic areas of focus namely:
* Financial management
* Infrastructure
* Human Resources
* ICT
* Quality of care
These are across government departments to ensure alignment and unity of purpose that will result in maximising outputs. The government and my department have implemented a number of pro-generic medicine policies and strategies and continue to do so, thus creating great opportunities for the generic pharmaceutical industry. Allow me to cite a few, without going into much detail.
* Enabling generic substitution framework
* Bolar type provision for registration of medicines
* Provisions for compulsory licensing
All these were in pursuit of affordability of medicines.
There is however areas that still require improvement. Recognising the inefficiencies of the MCC regarding long timelines, the following actions are being implemented:
* The President has signed an amendment act to review certain enabling sections of the Medicines Act and regulations to this act are being prepared. The aim is to reduce timelines and over-reliance on external reviewers, regulate complementary medicines, medical devices and in vitro diagnostics as well as strengthen pharmacovigilance and post marketing surveillance
* I have appointed a team of experts that is dealing with the backlog and the review of the MCC
* The timelines for approving clinical trials has been reduced from 16 to 20 weeks to 6 to 7 weeks on average. This will further be improved
* A joint committee has been established comprising representatives from three departments namely; the Department of Health, Department of Science and Technology and Department of Trade and Industry to specifically work together on pharmaceuticals, paying particular attention to early stage research, development of medicines and eliminating trade barriers in accordance with the global strategy and plan of action adopted last year at the 61st world Health Assembly. This plan seeks to implement new thinking on how to balance Intellectual Property Rights (IPR) and public health, thus ensuring access to medicines and related technologies. It seeks new thinking on how to promote and reward research particularly of conditions exclusively or heavily prevalent in developing countries. It further investigates innovative ways of funding such research.
* The government is committed to implementing the National Health Insurance (NHI) scheme
* There is already ongoing work to establish an office of standards compliance.
Pharmaceuticals are a significant cost driver in healthcare. Cost containment efforts are affecting most countries, including our own, as healthcare budgets are squeezed. Affordability of medicines is therefore critical.
Chairperson, may I suggest that sharper instruments are necessary to assess affordability of medicines and to ensure sustainability of services. As we move to the NHI skills in pharmaco-economics and evidence based medicine will be critical. Principles of non-inferiority, superiority, when interrogating the quality of evidence will need to be finely honed and understood by all involved in pharmaceuticals. We have to grapple with issues of efficacy versus effectiveness. We definitely need to work on our processes to maximise outputs. I therefore charge all your organised professional formations to ensure that your continuing professional development programmes, your in house training programmes and the academia, to ensure that relevant training and orientation takes place.
Chairperson, there are growing concerns on safety of medicines. Ageing populations have resulted in medical needs growing faster than healthcare budgets. Fewer chemical blockbusters are entering markets. Global warming may change disease patterns. Type two diabetes, cardiovascular conditions and cancer are becoming a growing problem globally and in South Africa. What does this mean to research and science? It seems biologics and biotechnologies are the future. New types of health products like gene therapy, proteomics and other targeted sub-molecular therapies will be technologies of the future. This may seem to be far in the horizon but I would urge that we cast our minds back to the discovery of antibiotics that seemed to be a dream. The same applies to monoclonal antibodies that were initially viewed with scepticism which has now turned to hope.
In this context, it is important that myths and truth around the safety and efficacy of biosimilars and other biologicals be cleared as a matter of urgency. Further research is however necessary to understand possible permutations in a society with a high HIV prevalence. Poor nations also deserve timely access to newer technologies.
All this is happening against a global crisis of human resources, a problem which is more acute in developing countries including our own country. Should we not be thinking of new skills that will be required in the future? Should we be looking at pharmaceutical sciences and not at engineers for modelling pharmacokinetics and pharmacodynamics?
In pursuit of timely access to technologies, we increasingly tend to concentrate on quality and efficacy and rely on limited data for safety. Timeliness is often driven by public health needs and a changing environment. Examples of this are the HIV pandemic, Avian flu, SARS, H1N1, to name a few. Closer to home we have the re-emergence of old diseases with new permutations like MDR and XDR TB. To manage the latter, we have had to go back to old technologies. Can we honestly say these technologies are safe? Has the risk/benefit balance been adequately addressed?
Chairperson, earlier, I mentioned the triple burden of disease. Allow me to come back to this point in the context of the HIV and AIDS pandemic. Traditional chronic diseases usually manifest from the age of 45 to 50 years. Now we have a chronic disease that manifests from the twenties. This means exposure to chronic medication for at least 40 to 50 years, assuming a lifespan of 60 to 70 years. What impact does this prolonged exposure have on the drug receptor sites, what side effects and adverse drug reactions may manifest, what will be the reaction when the traditional chronic diseases kick in? Will be there be a change in the age of onset of these? Should the generic industry therefore not be more involved in post marketing studies?
Let me boldly state that pharmacovigilance is not a nice to have but an imperative. It is everybody’s responsibility (patient, industry, regulator, academicians). It is not an additional expenditure but an investment.
In conclusion, though we are challenged by burgeoning science, we must always remember that the patient is central to everything we do. We have a joint obligation to society built on efficacy, quality and safety. We have an obligation to society to deliver the right medicine at the right time and in an affordable manner. We have an obligation to assist society to make informed decisions in their choices. The demand for healthcare is infinite and therefore requires prioritization.
We therefore need to identify:
* essentials (must do’s)
* expected (ought to do’s)
* desirable (can do’s)
May I wish you a successful and enriching congress. Though the challenges are many, there are opportunities too. May the seeds we plant today grow and produce fruit, not just for the next season, but for all seasons.
I thank you.
Issued by: Department of Health
5 August 2009
Source: Department of Health (http://www.doh.gov.za/)
