Below follows news of measures by the US Congress to levy considerable fees on the importation of generic medicines. The proposed Act will most likely lead to reduced generic medicine competition resulting in artificially high generic medicine prices. However, if the US FDA improves its medicine approval times, the fees contemplated in the Act may be offset by increased revenue. Some generic medicine manufacturers in India and China may be willing to pay the fees. Patients may benefit but only if it leads to greater competition and reduced generic medicine prices.
US FDA may impose huge drug user fee on generic imports soon, India to hit badly
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The US FDA may introduce a Generic Drug User Fee Act (GDUFA) soon to curb import of cheap generic drugs into that country. The proposed Act empowers the US government to fix an exorbitant fee on the import of each generic product category coming from any overseas sources. The US currently imports about 80 per cent of APIs and 40 per cent of generics made in the overseas locations.
The US Food and Drug Administration (FDA) recently completed and submitted its recommendations for the proposed Generic Drug User Fee Act (GDUFA) to the Congress. The proposed fees could range from $35,000 for API manufacturers to $150,000 for finished drug units.
The move is stated to help fund a portion of FDA’s drug review activities while FDA agrees to overall performance goals, such as reviewing a certain percentage of applications within a particular time frame. Indian industry fears that this move is a result of strong lobbying backed by the US generic industry to limit Indian competition from entering the US market.
What is more concerning is that the through the introduction of GDUFA, the US FDA is planning to impose higher fees for non-US facilities despite the fact that about 80 per cent of APIs and 40 per cent of US medicines are made in foreign locations. Expressing their concerns on this move, industry insiders pointed out that US FDA's claim for higher fees from the exporters is highly unwarranted since FDA has offices and staff in countries like India and China now.
An exporter to the US pointed out that this clearly shows that there are greater power of US generic industry working behind this move so as to stop competition form the Indian generic manufacturers.
Unlike the brand manufacturers who pay fees under Prescription Drug User Fee Act (PDUFA), the generic industry does not pay a user fee to support FDA activities related to its applications. Many industry insiders clarified that the Indian industry is not against GDUFA, which is designed to address the regulatory challenges in an affordable manner. However they pointed out that what they are concerned is about the unreasonable fees that is proposed to be levied from the exporters.
Reports point out that while large generic bodies were involved in discussions with the FDA over GDUFA, Indian industry was not part of these talks, despite the dominant role of Indian firms as suppliers. A reliable source from the industry stressed that the Indian industry, as key stakeholders, should have been given a direct chance to participate in these dialogues, which unfortunately did not happen.
The source implied, “Such increasing regulatory requirements, among others, would only threaten the sustainability of small API's and formulation firms in India. Even leading to many company to increase the price of drugs that are being exported to US leading to difficulty in access to affordable medicines.” It was further suggested that to deal with this access cost the US FDA can carry out joint regulatory inspections to help improve the situation and spare costs.
Other concern that the industry is facing is over whether the gains of faster approvals outweigh the costs and certainty of timelines involved under the GDUFA, since some experts say that while the FDA fees are required to be paid immediately actual commercialisation could be years away and comes with inherent risks.
Results from a recent survey by the Professional Provident Society of South Africa, (www.pps.co.za) reports that South African professionals are considering emigrating. The survey focused on specific occupations – chartered accountants, engineers, doctors, dentists, pharmacists, attorneys, advocates and other graduate professionals. Graduates are concerned about crime, healthcare and education as reasons for emigrating. Some of the results include:
- The number of professionals who are confident of remaining in South Africa for the foreseeable future declined to 78% from 84% a year ago.
- Confidence in the standard of education in South Africa improving over the next five years was also down 2% to 48% year-on-year.
- Confidence in the future of the healthcare system over the next five years fell 5% to 45% year-on-year. The deterioration in confidence is reflected by concern over the implementation of the National Health Insurance initiative with 84% of respondents saying it is not the solution to fix the country’s ailing health system.
The press release is available here.
Much of what we know from history about Gandhi relates to his practice of Satyagraha as a method to passively liberate India from the clutches of British imperialism. Little is known about his 20 year history of living in South Africa. That is until an extensive research in this area was published by G.H Singh in his book “Gandhi: Behind the Mask of Divinity”.
Singh’s thesis is mostly concerned with Sergeant-Major Gandhi’s actions and statements whilst living in South Africa from June 1893 to December 1914. Singh’s text is replete with evidence to support that Sergeant-Major Gandhi was a profound racist, and among those quotes is the following paragraph:
“In Ferreiras Township, a working-class suburb of Johannesburg, the population breakdown in late 1904 was listed as 288 Indians, 58 Syrians, 165 Chinese, 295 Cape Coloureds, 75 Blacks, and 929 Whites. Gandhi could do nothing about a place like the Ferreiras Township, but he claimed the right to speak on the racial composition of Indian locations. In February 1904, he informed the Johannesburg Medical Officer of Health, Dr. C. Porter that, “Why, of all places in Johannesburg, the Indian Location should be chosen for dumping done all the Kaffirs of the town passes my comprehension … Of course, under my suggestion, the Town Council must withdraw the Kaffirs from the Location. About this mixing of the Kaffirs with the Indians, I must confess, I feel most strongly. I think it is very unfair to the Indian population, and it is an undue tax on even the proverbial patience of my countrymen (p. 192) .”
Of course there is a risk that these words may be quoted out of context, but G.H. Singh goes to great length to contextualise all comments by Gandhi. He presents a compelling thesis to support the argument that “Gandhi was a racist to the bone when it came to black people (p. 308).”
I encourage anyone with an interest in race relations, particularly in the South Africa context, and anyone who has an interest in how crucial facts about leaders are (deliberately) lost in history, to read this book by G.H. Singh – it’s an essential text.
“The world’s population is aging, primarily as a function of declining fertility, coupled with increasing life expectancy. Aging is occurring not only in high-income countries but in middle- and low-income countries as well. Moreover, the speed of aging in middle- and low-income countries will outpace that of the high-income countries (Kinsella and He, 2009). Although considerable attention has been paid to the aging of populations around the world, the vast majority of this attention and related research has focused on higher-income countries. Yet about 65 percent of the world’s population 60 years and older lived in less developed countries in 2010, and this proportion is projected to be 80 percent by the year 2050 (U.S. Census Bureau, 2012).”
“As part of this greater effort, the World Health Organization’s (WHO) Study on global AGEing and adult health (SAGE) is working to improve measurement strategies across countries, while recognizing the need for further exploration to understand what underpins cross-country health differences (Kowal, et al., 2010). SAGE was conducted in six countries—China, Ghana, India, Mexico, Russia, and South Africa—across four different world regions (Figure 1). In addition to the consideration of geographic range and population size, these countries were representative of low- to upper-middle income countries and were at different stages of the demographic and epidemiological transitions (see Appendix C for more information on selection of SAGE countries).”
p95-12-01.pdfCall for Expressions of Interest
“This call aims to explore the connections between medicines and three other functions of health systems: health financing, governance and health information. ”
Priority-research questions include the following:
- In risk protection schemes, which innovations and policies improve equitable access to and appropriate use of quality medicines, sustainability of the scheme, and financial impact on beneficiaries?
- How do policies and other interventions into private markets impact on access to and appropriate use of quality medicines?
- How can stakeholders use information and data routinely collected and available in the system in a transparent way towards improving access to and use of quality medicines?
Download Call for Expression of Interest
The Wits University Fund appears to have lost the plot in their recent “Awards Dinner Invitation” (link below). Who in their right mind is willing to pay $300 for an individual ticket to attend this event. If you want a Patron table, you need $25,000. Come on Wits, what’s with this old, elitist model of fundraising? Wits, you have to make these things more accessible to all your graduates! For example, $30 dollars from 10 people is surely better than $300 from one person.
A link to the online Registration Form
Update 3 May 2012
Both Peter Maher (Director: Alumni Relations, Wits University) and Bill Newton (Volunteer Executive Director, Wits Fund) replied to the above post. I do not have their permission to post their replies, but below follows my response to their emails.
Dear Peter and Bill,
Let me start by thanking you for your reply but more importantly for managing, as a volunteer, the Wits Fund (Bill). It’s a thankless task for which very few benefits accrue to you, other than being associated with Wits University and having at your disposal a conduit for tax-exempt donations. It’s an unfortunate reality that running and managing such institutions is usually left to a handful of very passionate and dedicated individuals, such as yourselves.
Bill, your email suggests that individuals pay $300 to celebrate four individuals that have contributed significant time and financial support to Wits University. This just does not seem to be the right people to award or congratulate. What of the many hundreds of Wits graduates across North America and the World that are contributing in their chosen professional fields – academically, professionally, and in various humanitarian initiatives. It is these hundreds that Wits should be celebrating and not a handful of individuals. Some are fantastic innovators, others are on the cutting edge of policy reform, and others are changing the World in the best way they see fit. I completely understand your point that this is a fundraising event, and if it’s not a alumni cultivation event then the initiative should not, in my opinion, carry the name of Wits University. It should simply be a fundraising event for a select group of individuals irrespective of their affiliation with Wits University. However, it appears that your fundraising model depends entirely on your association with Wits. If the Wits Fund depends on Wits University for much of its activities, then it should be more transparent in how it runs its activities. For instance, in the interest of good governance, do you make available financial statements and annual reports on your activities? Surely, for a Fund associated with WIts University, this should be the minimum requirement, don’t you think?
Peter and Bill, let me be clear. My criticism of the fundraising model is exactly that, a focused message questioning the relevance and appropriateness of the fundraising strategy employed for the award dinner. The model suggests that individuals unable to pay for an individual ticket (the majority) are unwelcome. Like I said in my message posted online, it is an old and elitist model of fundraising. On this topic I could comment extensively, however, to be brief, I’d like to highlight that there are lessons to be learnt from the fundraising modernization associated with US President electoral campaigns. So, my comments were not aimed at soliciting an invitation to become a Wits ambassador, or to be associated with the Wits Fund, or to participate in alumni cultivation activities Peter suggests. On all these fronts, I wish you the best of luck in your work.
Like I suggested in my initial message, collecting $30 from 10 people is in my opinion a far more inclusive process than collecting $300 from one person. Thank you again for all the work that you have put into establishing and running the WIts Fund. If the Fund is a private initiative unwilling or unable to reform its fundraising model, then alternative approaches should be developed that are inclusive and that celebrate the majority and not only a handful of individuals.
Many thanks and all the best,
João L. Carapinha
