[e-drug] Suggestions for Pharmaceutical Policy and Management Course at UWC

E-DRUG: Suggestions for Pharmaceutical Policy and Management Course at UWC
-------------------------------------------------------------------------------------------------

Hi E-Druggers,

Since I posted my message on April 2nd I have received some very interesting responses.

The first from Nadiya Alnoor Jiwa from Mbeya in Tanzania was:
" Adding my two cents to the thought, I think health economics, and particularly, pharmaceutical economics would play great role in guiding policies for our countries in Africa.

I can only agree. I was interested that Nadiya wrote about pharmaceutical economics and not pharmaco-economics. My understanding is that pharmaceutical economics is a broader subject encompassing financing, costing as well as assessing value for money which I take pharmaco-economics to mean. But this is not a universal understanding as some web sites use the terms interchangeably.

I know that Utrecht University runs a short course on pharmacoeconomics but I think this is focused on assessing value for money. While this aspect is important, in LMICs understanding medicine financing options is critical especially as countries move to UHC.

The prices of medicines are often not considered in traditional pharmaco-economic or in Cost Effectiveness Analysis undertaken by Health Economists. But we know from the WHO/HAI studies that prices vary enormously. So in a LMIC Pharmaceutical Policy and Management course I would want to look at financing, pricing and value for money.

In South Africa, issues around pricing are less controversial as the government defines a Single Exit Price (SEP) for the Private Sector and has a relatively efficient national public sector tender system for the public facilities.

I received a very interesting comment from Tom Kauki from Kenya. He suggested the following topics could be considered

1. Legislative frameworks. What should a model law on regulation of medicines and pharmacy practice contain as a minimum?
2. Politics in the pharmaceutical sector
3. Harmonization of medicines regulations (East Africa Community is interested in this)
4. Pharmaceutical Policy research methodology
5. Health Technology Assessment (real world effectiveness of pharmaceutical products through price assessments, market availability etc.)
6. Taxation of pharmaceutical products (VAT, Customs)
7. Policy on parallel importation of medicines.

These are all interesting topics, some of which will be covered in the planned course.

I will comment briefly. While a model law sounds attractive I worry that such a law could get forced on a country as a condition of joining a trade area or as part of harmonization activities. The danger is that if the nationals who will be affected by the law do not support the law they will find ways to get around it or subvert the law.

I think harmonization of medicines regulation is an interesting topic and you know that the World Bank, WHO and Gates have been trying to facilitate the process in East Africa. My impression is that everyone is happy to support harmonization provided everybody else harmonizes with me!

The question about pharmaceutical policy research methodology is one that I am personally interested in but I wonder how many of the potential course participants would be interested. Comments welcome.

The issue of Health Technology assessment often comes up. My attitude is that selection of essential medicines is a relatively simple form of HTA. But many countries struggle to do this well. How often do we see the national EML does not match the national Standard Treatment Guidelines or the national medical stores stock list. I would rather focus on policy issues around selection and use of medicines. But again comments would be welcome.

Taxation of pharmaceutical products is an issue I have been interested in for many years. I think is awful that the sick (who are often poor because they are ill) are preferentially taxed because they are sick. The problem however is that when such taxes or duties have been removed in some countries the prices to patients did not go down and the profits for the importers, wholesalers and pharmacists went up. So finding a policy that would ensure that the patient benefitted would be important.

Parallel importation is often suggested as a way to address high medicine prices even in the US. The issues that do come up often revolve around quality assurance and ensuring that the patient benefits not the intermediaries who manage the process.

All of these are interesting topics and it may be that we could have one session in a future course on "Hot Topics" in which course participants could choose to debate one or two topics.

The last message I received was from Mariana Santos who is working in Ukraine. She suggested that in the introductory session we should discuss the life cycle of medicines from development, regulation, supply chain and (I assume) use. She suggested this because she observed that some pharmaceutical specialists work in niches or specific areas and that a policy maker needs to be aware of the whole environment.

I find this to be a very useful comment as it is easy to focus on the details of components within the pharmaceutical system while losing the big picture. I will be happy to include the life cycle in the introductory session but I would like to try to come back to the big picture at the beginning and end of each day of the course.

If anybody else has any comments, do please post them to E-Drug and we can continue this discussion. If you disagree with anything that I have written please make your case as I often feel I learn more in a debate than a lecture!

For additional information about the UWC courses please contact Dr Hazel Bradley
Tel: 021 959 2630,
Cell: 072 297 9932,
Email: hbradley@uwc.ac.za<mailto:hbradley@uwc.ac.za>

or websites:

http://www.uwcsoph.co.za/index.php/news-and-announcements/faculty-announcements-events/160-pharmaceutical-public-health
http://www.uwcsoph.co.za/index.php/short-courses/winter-school

Thank you,
Richard Laing
Professor, Department of Global Health and Extraordinary Professor at University of Western Cape
Boston University School of Public Health,
richardl@bu.edu

E-DRUG: [e-drug] Suggestions for Pharmaceutical Policy and Management Course at UWC(2)
-------------------------------------------------------------------------------------------------

Richard

I think your comment on regulatory harmonization should be reconsidered.

First, harmonization efforts are progressing much faster than many may know. Not only has a model law on regulatory harmonization been passed by the Africa Union (disclosure: I worked on the Model Law), there have been concrete steps taken in multiple countries to operationalize the model law:

http://journals.ke-i.org/index.php/mra/article/view/1668/1748

Of course, we have as well the WHO Prequalification Program, which is well known and which is designed to help fast-track registration, and the WHO Collaborative Registration Procedure, which is less well known:

https://extranet.who.int/prequal/content/collaborative-procedure-accelerated-registration
and which actually helps accelerate registration of prequalified finished products and finished products approved by stringent regulatory authorities. We know as well of special EU regulatory procedures to register products intended for LMICs.

The broader problem is that LMICs are wasting scarce regulatory resources to duplicate evaluation of registration applications, which creates barriers to registrations by both originators and generics, unnecessary and protracted delays, and crushing inefficiencies even where population level differences are insignificant in weighing safety, efficacy, and quality.

Resources that might better be spent on local inspections, pharmacovigilance, and supply chain monitoring are wasted on unproductive and unnecessary regulatory reviews.

Yes, there are turf battles over regulatory approaches, centers of excellence, specialization in regulatory reviews, etc., but all of these are manageable in the services of faster access to medicines of assured quality.

Brook

Professor Brook K. Baker
Northeastern U. School of Law
416 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal
Health GAP (Global Access Project) Senior Policy Analyst
b.baker@northeastern.edu