Dr. Caleb Ademola Gbiri is a lecturer with University of Lagos College of Medicine and also a Neuro-physiotherapist with the same institution.  In this exclusive interview with Pharmanews in his office recently, he expressed his displeasure towards the unfavourable condition which he said physiotherapists are subjected to in the country.

The university don, who spoke extensively on the importance of a physiotherapist to an hospital, however, lamented that poor conditions of service and bad policies of government were part of the reasons why physiotherapists are few in the country.

Read the details below:

I am Caleb Ademola Gbiri. I am a lecturer with the University of Lagos College of Medicine and I am also a Neuro-physiotherapist.

What is physiotherapy all about?

Physiotherapy is about management of all disease conditions with minimal use of drug.  It also involves preventive mechanism towards preventing disease condition and also rehabilitative and curative.  Some conditions are not curable, but you can improve on the quality of life and functional performance of such an individual, while some are curable. So, physiotherapy moves from preventive to curative and to rehabilitative.  Contrary to so many people’s belief that physiotherapy is all about taking care of injury.  That is partially correct, in the sense that we have an aspect of physiotherapy that deals with muscular skeletal injury and sport injury.  Those sets of people deal in both prevention and rehabilitation of patients after injury.  What they do basically is treat injury as a result of any muscular skeletal accidents.  However, instead of talking about injury, I would rather call it abnormality or pathological persons, in which physiotherapy is involved in restoring the functional performance of an individual who has a deviated functional performance from the norm.

To a lay man, who do we call a physiotherapist?

A physiotherapist is a health care practitioner who treats all disease conditions with minimal use of drug by the use of physical modalities like exercises.  Physiotherapists use a lot of physical modalities and we de-emphasise, as much as possible, the use of drug.  They only use drug where it is highly mandatory and they have a means in which they send the drug into the system, and not orally.  Some people would say physiotherapy is all about bones, while some would say it is about muscle.  It depends on whom they have had contact with, because physiotherapy is a broad spectrum of specialties, which have more sub-specialties within.

Why are physiotherapists very few in the country?

The condition of service is one of the major reasons why physiotherapists are few in this country. You see, health sector is an heterogenous sector and we have discovered that there is more favourable condition and outcome for physiotherapists outside the country than those practicing here.  Nigeria actually produces sizeable numbers of physiotherapists but because of conditions of service like remuneration, work conditions, and of course, for example, we have not seen a physiotherapist becoming a Chief Medical Director of a hospital, but outside the country, those things are obtainable.  Therefore, the practitioners would want to go to where the condition of service is juicier than what we have here. The importance of physiotherapists is less recognised here in Nigeria; meanwhile, they are treated as kings outside the country.

What is the importance of a physiotherapist to a hospital?

I tell you, no hospital can function adequately without a physiotherapist.  I am repeating, no hospital can function adequately without a physiotherapist.  Because you would discover that, in my definition, I said a physiotherapist is involved in all disease conditions, and also in the prevention modem in the health sector.  Take a stroke patient, for example, it is not only giving drugs to a stroke patient that would make him or her to return to the pre-stroke activities.  It involves a neuro-physiotherapist to rehabilitate the person back to normal.  Meanwhile, the drug would only modulate the blood pressure and other parameters.  Every patient that has undergone surgery must have a physiotherapist and therefore, any hospital that is having surgery and does not have a physiotherapist tends to have problems.  We also have obstetrics and gynaecology physiotherapists (O&G), and this set of people are involved with women’s health, from peri-natal period, anti-natal period, delivery period and post-natal period, they are all involved in delivery and post delivery process.  You see a lot of people play down on the significance of physiotherapists, but until a patient is exposed to all the spectrum and utilises them, then, the patient has not being adequately cared for. So, no hospital, including the primary health centres, can function adequately without a physiotherapist.

Compared to what is obtainable in advanced countries, how would you assess physiotherapy practice in Nigeria?

In terms of ability and capability of physiotherapists in Nigeria, they are at par with their counterparts elsewhere, but when it comes to exposure to facilities, remuneration and conditions of service, they are at the lowest spectrum of the ladder, and that is why we see a lot of practitioners emigrating to all those advanced countries, because there are better conditions of service in those places.  So, if we can make it better here also, even if it’s not up to that of those places but a little bit comparable to it, most of these people outside would prefer to stay here, and they would contribute to our health care development.  In Nigeria, our physiotherapy patient ratio is very low, when you compare it with WHO standard. In Nigeria presently, we don’t have up to one thousand physiotherapists practicing in Nigeria effectively, and we have over one hundred and sixty million population.  You can imagine what would happen at the end of the day. There was a time a patient was referred to (OAUTH) Ile-Ife to see a physiotherapist but before he got there, we lost the patient.  We are not having access to what we are supposed to have access to, and the few people that have access to it are not in the country.  Meanwhile, recognition is also another problem, and this recognition falls in different places, on the part of government and on the part of policy makers.  For example, we were talking about health policy and health bill in the National Assembly; you would discover that there has not been any input from physiotherapists into this bill. It is worrisome seeing somebody who is not a physiotherapist deciding what we should be earning, as physiotherapists; this can be very embarrassing. Also, in the National Health Insurance Scheme (NHIS), physiotherapists have not been factored into it; and among the just constituted the Board of all Teaching Hospitals and Parastatals, there is no physiotherapist in any.  How would a person who does not know what is happening in a profession decide for that profession? It is impossible.  So, at the end of the day, despite the fact that the health care sector is a heterogeneous sector, we are operating a monogenous focused approach.  In terms of remuneration, a physiotherapist who had been practicing for more than ten years is not earning as much as another health care professional who just graduated two years ago.  How would you think that such a person would be motivated?  The person would rather look for a better option elsewhere by going outside the country. Again, there should be establishment of a directorate for physiotherapy in the ministry of health that would oversee into the running and policy making of physiotherapy service.

How affordable is it to consult a physiotherapist?

I would say that one of the goals of physiotherapy is to make the service affordable and accessible to everybody, irrespective of your cadre.  Therefore, the only problem we are having is awareness, on the part of the populace. A lot of the time, the condition that should go for the physiotherapist would be taken to other practitioners, or even general practice, especially in the private hospitals; their referral system is nothing to write home about. They hardly refer and they like to optimise the income and so they won’t involve professionals to manage specific conditions, and at the end of the day, they complicate the problem of the patient.

The President of Nigerian Medical Association (NMA), Osahon Enabulele, recently proposed life imprisonment for quacks, as a means of stamping out quackery in the medical profession.

Enabulele made the call when he spoke in Abuja, where he also said the issue of quackery was a challenge facing the NMA and particularly the growth of health care practice in the country.

He advised governments at all levels to take the issue of quackery very seriously and responsibly, saying it was endangering the lives of Nigerians. He also urged Nigerians to work closely with the NMA, in its bid to put an end to quackery.

“With respect to the issue of quackery, the NMA, more than any other organisation, has been challenging the people of Nigeria to partner with her, to ensure that issues of quackery are seen as things consigned to the dustbin of the history of Nigeria.

“In 2012, for the first time in recent times, a professional organisation like the NMA disciplined its own member and made it known to the public, as a way of letting the public know that we can no longer do things the old ways. We call for things like life imprisonment for quacks, because they are doing untold harm and damage to the people of Nigeria,” he said.

A nongovernmental organisation, Christian Rural and Urban Development Association of Nigeria, CRUDAN, South West, has decried the worsening state of child and maternal mortality rate in the country.

In a paper titled, “Commitment to family planning/childbirth spacing for healthy families and national development”, the group’s South West coordinator, Adesina Adeduntan, said CRUDAN’s worry emanated from various findings it gathered from programmes it organised with civil society and community based organisations.

“Recent data reflect the poor state of maternal and child health in the country, as they show that Nigeria is losing women and children, as a result of high risk pregnancies (pregnancies below age 18 years, above age 34 years, birth interval of less than 24 months apart and birth order of 5 and above),” the statement reads.

Citing United Nations estimate of year 2000, CRUDAN noted that about 52,000 Nigerian women still die every year, as a result of pregnancy, delivery or post delivery complications, while out of every 1,000 live births, 201 children die before they attain the age of 5 years.
The group further noted that, if the worsening trend is to be mitigated, there must be a commitment to increase the use of family planning, child birth spacing methods (CBS contraceptives and natural).

“Evidence abounds that family planning/child birth spacing, will reduce 88,400 of the current 340,000 infant deaths annually, if women in any risk category avoid pregnancy. Also, the lives of about 13,000 women, who die annually as a result of induced abortion, will be saved, if there is increase in uptake of family planning/child birth spacing, CBS services, among others,” the statement reads.

CRUDAN also urged government at all levels to show more commitments in improving the nation’s health care delivery system through structural and legislative frameworks.

“CRUDAN hereby calls on government at all levels and other relevant stakeholders to: formulate Family Planning/Child Birth Spacing policy, enact laws promoting family planning/child birth spacing issues, create budget lines for family planning/child birth spacing and release allocated funds, promote and strengthen public private partnerships for family planning/child birth spacing programmes, support capacity building of service providers and the provision of equipment and commodities for family planning/child birth spacing, as well as include family planning/child birth spacing services in the National Health Insurance Scheme,” the statement reads.

By Adebayo Folorunsho-Francis ——

Sequel to an appeal from the Pharmaceutical Society of Nigeria (PSN) to the Federal Ministry of Education to prevail on the National Board for Technical Education Board to scrap the Pharmaceutical Technology Diploma Programmes in polytechnics, the National Association of Pharmaceutical Technologists and Pharmacy Technicians of Nigeria (NAPTTON) has chided the society for making such remark.

In an official statement signed by its President, Alhaji Yusuf Hojapa, NAPTTON declared that such programmes are still needed in the country.

It would be recalled that the PSN had frowned at the initiative of the NBTE offering of diploma programmes in Pharm Tech during its annual general meeting at the 85th annual national conference in Abeokuta, Ogun State in November last year.

Among other things, the conference strongly urged the Federal Ministry of Education to immediately direct the NBTE to stop such programmes which PSN believes could introduce new dimensions in quackery in drug distribution as is already being witnessed in some Southern States in Nigeria.

In an official communiqué released to the media, the pharmacists emphasised that the “Conference found it necessary to draw the attention of the Federal Ministry of Education to statutory powers of the Pharmacists Council of Nigeria to regulate pharmacy practice and training in all aspects and ramifications in Nigeria.”

Consequently, the PSN is calling for a total scrapping of the programme on the grounds that pharmaceutical technology is a postgraduate specialty in universities.

Hojapa however disagreed with the notion. He insisted that pharmaceutical technology programmes operate freely in Ghana and other countries, adding that it was surprising that the NBTE was planning to do them.

The NAPTTON appealed to the Minister of Education, Prof. Rukkayat Rufai, to disregard the suggestion to scrap the programmes, adding that the programmes would rather advance pharmacy education and practices in the country.

“We at NAPTTON condemn the recent call that Pharmaceutical Technology Programme being anchored by NBTE be stopped by the Minister of Education.

“Pharmaceutical Technology programmes (ND/HND) operate freely in Ghana and other climes, hence one wonders why any group should pull woods on the face of the distinguished Minister of Education who is well-informed about developments internationally,” he said.

As Prince Adelusi-Adeluyi canvass for teamwork among health professionals

By Adebayo Folorunsho-Francis

In appreciation of his resilience and commitment to importing quality drugs, Prince Christopher Nebe, chairman, PharmaDeal Nigeria Limited has been given an award of excellence by the Association of General and Private Medical Practitioners of Nigeria (AGPMPN).

The event which attracted doctors, pharmacists and several health professionals took place at the Lagos Sheraton Hotel, Ikeja, on 4^th December, 2012.

Also in attendance were Prince Julius Adelusi-Adeluyi, chairman, Juli Pharmacy Plc, Dr Jide Idris, commissioner for health in Lagos State, Dr (Chief) Adeyeye Arigbabuwo, AGPMPN chairman, Dr Anthony Omolola, AGPMPN national president and Chief Michael Oyebanjo, chairman, Mopson Pharmaceuticals among others.

In his keynote address, Prince Adelusi-Adeluyi, who also doubled as chairman of the event attributed the woes plaguing the country to leadership problem, adding that there is indeed a need to return to ethical practice.

The chairman explained that he understands things are quite tough thereby compelling many people to ‘cut corners.’

“Once you are able to do this, you will make a lot of money and be respected in the society. But in truth, only a man of character can be trusted. One of these men of characters are health workers. As professionals, you must learn to be contented with your professional practice,” he said.

Prince Adelusi-Adeluyi appealed to people in the medical field to recognise the need for cooperation with other team players like pharmacists, laboratory technicians, radiographers, NAFDAC officials and a host of others.

He used the example of Kate Middleton, Duchess of Cambridge who was recently told to have a bed rest due to her pregnancy, stressing that her safety suddenly necessitated the presence of relevant health professionals to get their opinion.

“As I mentioned earlier, we all have relevant roles to play if there is ever going to be any hope for this our dear country – Nigeria.

Among other recipients who also received awards of honour at the night were Prince Julius Adelusi-Adeluyi, Chief Michael Oyebanjo, Dr Tosin Ajayi, chairman, First Foundation and Dr Abdulrahman Sambo, acting secretary, National Health Insurance Scheme (NHIS).

By Pharm. Nelson Okwonna

 NIPRISAN, more popularly or formally known as NICOSAN™, is a herbal formulation for the management of sickle-cell disease(SCD) developed by indigenous researchers at the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja, Nigeria. NIPRISAN, as claimed in the patent, is a herbal mixture extract, formulated from parts of four different indigenous plants (Piper guineenses seeds, Pterocarpus osun stem, Eugenia caryophylum fruit and Sorghum bicolor leaves) and an inorganic material mixed at specific ratios which has been shown to be safe and effective in the management of sickle cell disease during a phase 1 and subsequent Phase 2 clinical trials.

In his article: “NIPRISAN Case, Nigeria: A Report for GenBenefit” published in 2007. Professor C. Wambebe described the events that led to the development of the therapy for sickle cell disease by indigenous researchers. Under his leadership as the Chief Executive officer, the management at the National Institute for Pharmaceutical Research and Development (NIPRD) had focused on indigenous medical knowledge in their search for a therapy for SCD.

They had received credible information about Rev. Ogunyale who was treating SCD patients with a herbal medicine. Rev. Ogunyale was then invited to discuss possible collaboration with the NIPRD. After some negotiations, he released his recipe, as a sacred trust, for further development into an effective medicine for the benefit of SCD patients globally.

According to Article 27 of Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, patents can be granted in all fields of technology vis-à-vis processes and products with the exclusion of plants and animals. However, the caveat that natural substances do not qualify for patentability applies directly to plants, animals and micro-organisms, it does not infer that the technical processes applied to develop a product with a potential for future commercialisation for specific public use cannot be patented. The patenting of NIPRISAN in the USAwas undertaken under this premise.

Considering the amount of time and money spent in obtaining a patent, the effort should be worth it. A patent should have economic value to the holder and the process for actualising the economic value for a patent should be well considered before the patent is filed. For instance, it could be wise to delay filing a patent for a drug molecule if it would take another ten years to get to the market, as the market exclusivity provided by a patent is usually  between fourteen and twenty years from the date of filing.

The risk of exposure prior to filing should be weighed against the time advantage of a delayed filing. Copying and adding a slight modification in the nature of an existing patented material could justify obtaining a new patent for the modified material. This could be an effective business strategy. Another strategy is to wait and copy! Waiting for a patent to expire and then reproducing the product or process is a good means of developing generic drugs.

A proper intellectual property protection infrastructure assures the knowledge workers that they would reap maximum benefits from their creations.

LICENSING

A patent, trademark or copyright can be licensed to a second party other than the assignee. In the case study, Xechem Pharmaceutical Nigeria Ltd was the licensee responsible for the further development and marketing of NIPRISAN. The product was marketed as NICOSAN™ Licensing allows the holder of the proprietary rights to leverage on the finances of other parties. As shown in this story, the product was licensed to Xechem who were able to raise the financing for further development and had the capacity to commercialize the venture.

A licensing agreement usually grants the licensee the rights to use, make, manufacture and sell products under the rights granted by the licensor in a given territory. These rights granted by the licensor to the licensee can be sole, exclusive and non-exclusive.The licence issued to Xechem in this case study was an exclusive license. A patent does not confer marketing rights for certain regulated products like drugs, food and certain technology. These would still need to be approved by certain regulatory agencies before they can be used in a particular country. NICOSAN™ was approved for marketing by the National Agency for Food and Drug Administration and Control (NAFDAC).

INDUSTRY PARTNERSHIP

A patent does not automatically imply resource generation. There should be an effective strategy for converting the invention to money. The strategy should be one that yields sufficient returns on the investment before the market exclusivity expires and “generics” begin to flood the market. Collaboration is therefore a necessity. There is a big difference between the language of research and that of commerce, and a bridge is necessary to translate the products of research to useful products on the shelf. As shown by the Honourable Minister, Prof. Turner Isoun in our story above, that bridge is arrived at via conscious, deliberate efforts.

The first deliberate effort is to develop products of research with economic potentials. The next deliberate step is to achieve intellectual property protection. Intellectual property protection assures market exclusivity and justifies the partnership with the industry which is in desperate need of the rewards of such market exclusivity. Leadership in research implies understanding the limitations of a solo effort and hence the need for collaboration amongst researchers, development consultants and industry. A research development consultant could be needed to design and implement a mutually profitable strategic framework for partnering with the industry. This ensures that the often eccentric academic researcher is not exploited by the perceived “sharks” in the industry.

Once an interested party is identified and talks begin, there are a number of options that might be selected to develop the product.

1. The research team could develop a company, raise money and build a business around their product: Examples are Google, Research in Motion, Apple Computers, and even the numerous companies that Thomas Edison founded to produce his inventions. To achieve success, however, the research team should have the necessary managerial competence. If need be, the researcher or research team could offer ownership for managerial competence. This was how Bill Gates got Steve Ballmer to join Microsoft.The process of finding such funding is either from personal savings, loans, profits from the business, venture financing or public offers.
2. Secure a royalty agreement by licensing the product to a second party as was done with

NIPRISAN.The following are the payment options under a Licence agreement:

a)          Lump sum fee

b)         Percentage of net sales

c)          Percentage of profit before tax

d)         Combination of lump sum fee and a percentage of net sales

e)          Combination of a percentage of net sales and a percentage of net profit before tax

The NIPRD-Xechem collaboration was for a good faith payment of $115,000 and a 7.5 per cent of gross sales as royalties.

The first option has always been shown to be more profitable especially in our time and age. A challenge, however, occurs when the competition is such that the new small company is unable to compete fairly in the market.

Assuming you are to develop a much better mobile technology, as was the case with the development of the Blackberry device by Research in Motion Inc., the size of the competition is enormous. To compete, the new firm should have fairly large financial muscles in addition to her intellectual property protection. To achieve this, she might need to leverage on the partnership of individuals or organisations with some very deep pockets or partner with one of the existing large firms. The strategy for making such an entry is often as much or sometimes even more important than the innovation itself. Most of the time, these new firms resort to venture financing and then subsequent initial public offer on the stock market – Research in Motion Inc. took this path.

Reference

1. Okwonna, N. (2012). The Heart and Art of Innovation, Onel Media Services, Lagos, Nigeria

By Nelson Okwonna

The National Institute for Pharmaceutical Research & Development (NIPRD) established through the Science and Technology act (1987) has as one of its mandates the development of herbal medicinal products (Phytomedicines) up to pilot stage for commercialisation. The Institute has over the years endeavored to achieve this, with NIPRISAN as an example in this regard.

The Institute currently collaborates with Traditional Medical Practitioners (TMP) towards fulfilling this mandate but the synergy and uptake of research results is slow or non-existent. Advocacy for effective and continuous collaboration with all key stakeholders in herbal drug industry in Nigeria is therefore important and urgently required. NIPRD is currently exploring new opportunities to achieve this.

Not all TMPs are aware of the benefits embedded in adding science to their medicinal herbal product, while the Nigerian Pharmaceutical industry has not fully tapped into the resources available for Pharmaceutical Research in NIPRD and in the utilization of its R & D results.  These are some of the impediments in the drug development process from Nigerian medicinal plants, which have huge health and economic benefits for the nation.

Fostering effective uptake of Research results from NIPRD is one of the targets of the Institute’s strategic plan (2011-2015). This strategy is supported by the Nigerian Traditional Medicine Policy and the National Strategic Health Development Plan (NSHDP) of the Federal Ministry of Health. This is because it is widely recognised that such collaboration could bring huge health benefits to the populations, especially in controlling the HIV/AIDS pandemic and malaria; diseases which have placed a heavy burden on already weakened health systems in Nigeria and sub-Saharan Africa.

In pursuit of this objective, NIPRD organised a stakeholder’sforum on the 30^th of October with the theme: Strengthening the Research and Development processes for theCommercialization of NIPRD Phytomedicines(A case study of antidiabetic phytomedicine).

The World bank sponsored forum was well attended by pharmaceutical researchers and Traditional medicine practitioners although there were not enough representation from industry.

The forum afforded NIPRD the opportunity to get feedback on its performance and expectations from the Nigeria Pharmaceutical Industry and Traditional Medical Practitioners.

It was also a time for stakeholders to determine the challenges and prospects of partnership between Traditional Medicine Practitioners (TMPs) and scientists involved in drug development suggesting way forward.

NIPRD also took the opportunity to highlight to the Nigerian Pharmaceutical industry, the commercialisation opportunities inherent in her drug development activities with special reference to the STEP B antidiabetic project.

At the end of the forum the participants arrived at the following communiqué:

• There is a huge market for traditional herbal medicine left untapped in Nigeria.
• There is a disconnect between the stakeholders in pharmaceutical research and development (Scientists, TMPs,  and the industries)
• There is need for deliberate means of building confidence and trust amongst NIPRD, TMPs, Scientists and pharmaceutical industry.
• There is need for demand driven collaborative research involving scientists from universities, research institutes, pharmaceutical industry and TMPs.
• There is need to create awareness amongst stakeholders on the existing laws that protect intellectual properties of individuals, scientists, TMPs, and communities.
• There is need for funding research and development (R and D) through private-public and community partnership
• There should be increased exchange of researchers between research institutes, universities and pharmaceutical industries.
• There is need for diffusion of information to and from the TMPs, scientists and other stakeholders.

By Pharm. Nelson Okwonna

 Developing nations with unique features like large market size and growth rate, access to regional markets and skilled/cheap labour, have a lot to offer. Asides serving as consumer nations and probably manufacturing centres due to the relatively cheaperlabour, the earnings of these nations would be greatly increased when they begin to add a relatively cheaper  not only mass-produce but to also add a certain level of originality to their products.

For such nations, their global competitiveness can be greatly increased when it is difficult to find alternatives for their products without violating proprietary rights. In the Nigerian pharmaceutical industry, finding originality would be the next step after achieving an effective manufacturing capacity and the firms that would solve this riddle would be the kings of the future. This has been amply demonstrated in the Indian pharmaceutical industry.

Innovation, however, do not just come about. According to the founder of modern management, Peter F. Drucker, it is a product of a cold-eyed commitment to the source of innovation; it demands deliberate inquiry and organisation.

The term “National Innovation Systems” is used to describe the set of complex processes of interactions between private and public actor-institutions that are involved in the development, transmission, modification and commercialisation of new knowledge and technology within a nation. It is a process-based concept that seeks to evaluate the innovative capacity of a nation from the standpoint of the processes that lead to innovation.

The Innovation system approach is a deviation from the linear approach that evaluates inputs rather than processes. Before the concept of National Innovation Systems became common, a Nation like Nigeria could assess her commitment to developing new technologies and enterprise by measuring the amount of funds committed to research and development, the number of publications from her academic institution, and also by the amount and ease of access to R and D funding by the Industry.

The linear approach assumes that as long as researchers engage in research activities and government provide the right incentivesthat someday, the spark would happen.

This has not been found to be true; experience has shown that the level of interaction between the actors plays a more important part.

It is observed that certain localities happen to have a relatively higher level of innovative capacity. In these regions, nations or parts of a nation, the amount of inputs and the degree of interaction required for innovation to happen has been achieved and sustained. This is seen in the notable trend towards the creation ofspecialised knowledge centresnear leading universities that are oriented towardsresearch and development on particular technologies.

The Silicon Valley in California (near Stanford University and theUniversity of California), a biotechnology cluster in the Boston area (near theMassachusetts Institute of Technology) and a communications cluster in NewJersey (near Princeton University and the former Bell Laboratories) are examples of such innovation-clusters in the United States.

Thequantity and quality of interaction between Actor-institutions could be evaluated along these lines:

1. Interactions among enterprises, primarily joint research activities and other technical collaborations.

1. Interactions among enterprises, universities and public research institutes, including joint research, co-patenting, co-publications and more informal linkages.

1. Diffusion of knowledge and technology to enterprises, including industry adoption rates for new technologies and diffusion through machinery and equipment; and

1. Personnel mobility, focusing on the movement of technical personnel within and between the public and private sectors.

It has been shown that high levels of technical collaboration, technology diffusion and personnel mobility contribute to the improved innovative capacity of enterprises in terms of products, patents and productivity.

Within the Nigerian Pharmaceutical Industry, the actor-institutions include the pharmaceutical companies, academia, public pharmaceutical research institutions, clinical research centres, technology transfer offices, government, financial institutions, media, and knowledge management consultancy firms.

From my experience in the knowledge management Industry, these actor-institutions have achieved a certain level of development sufficient to be active participants in sustainable innovative frameworks. The missing link is the deliberate commitment to processes that ensure sufficient and effective interactions. This will demand conscious steps to remove the traditional barriers that impede this interactions.

These interactions could be in the form of industry-sponsored research collaborations, contracts, research industry forums and technology prizes initiated by Industry. They could be initiated by either the private or public sector provided that there is sufficient ownership across board.

Given the relatively divergent thought frames that prevail within Industry and pharmaceutical research institutions and the myriad of other concerns that relate to intellectual property management, actor-institutions that promote thisinteraction would have a great role to play in achieving a sustainable innovation system within the Nigerian pharmaceutical sector.

Fig. 1 Schematic Representation of National Innovation Systems

As shown above, at the heart of the National Innovation system is the innovative firm which must find within the myriad of actors, processes and strategies that would result in the profitable development of new products and services. The role of the government would be to stimulate greater inputs across the participating actor-institutions and reduce barriers to interaction.

The Nigerian Science, Technology and Innovation Policy document that was released of late has these words as the statement of commitment from the president, Goodluck Ebele Jonathan.

”We are going to run our economy based on Science and Technology….because there is nowhere in this World now that you can move your economy without science and technology. For the next 4 years we will emphasize so much on S&T because we have no choice, without that we are just dreaming….”

The President was right; towing the path of innovation is no longer the characteristic high sounding ideals of beady eyed researchers or is it restricted to corporate vision statements hung on the wall to massage the ego of executives and perhaps impress shareholders. Driving innovation in today’s global knowledge economy is basically a question of survival.

For the Nigerian pharmaceutical Industry, it could decide who would be here ten years from now.

References

1. Drucker, P.F. (2003). The Discipline of Innovation. In Best of HBR, The Innovative Enterprise, Harvard Business Review, EBSCO Publishing.
2. Federal Republic of Nigeria, 2011. Science, Technology and Innovation (STI) Policy, September, 2011.
3. Okwonna, N. 2012. The Heart and Art of Innovation, Onel Media Services, Lagos, Nigeria
4. Organisation for Economic Co-Operation And Development. 1996.National Innovation Systems, 1996.

By Pharm. Nelson Okwonna

The recent Samsung-Apple saga has given us ample opportunity to discuss and reflect on the roles of intellectual property, in an increasingly knowledge-dependent economy. We are getting more familiar with the word “patents”. Though patents and other intellectual property have played very important roles in the development of global economies, in many parts of Africa, they are still not very much understood.

Our academic curriculum, somehow, is deficient in the aspect of knowledge management and this is very worrisome. It is worrisome because it is difficult to drive sustainable development in a global economy, without a proper understanding and application of intellectual property protection and commercialisation.It is quite laudable that a good education should equip us to perform specific defined functions; however, it is more laudable when education empowers us to create.

For every resource available to man, the application of knowledge is what would expand its value. We go to school to be taught, crude oil needs to be refined, sand has to be made to silicon, words can become codes and a couple of good ideas can give you an IPad. This application of knowledge to increase value is what patents seek to achieve. It thrives on the wheels of self-belief.  Those that engage in development endeavours must first believe in themselves, because protection of intellectual property requires that an individual possesses a certain body of knowledge which he values enough to protect his right to it.

DEFINITIONS

According to the World Intellectual Property Organisation (WIPO), intellectual property refers to creations of the mind. Intellectual Property Right (IPR) therefore, refers to property rights on the creations of the mind. IPR is generally divided into two main categories – industrial property and copyright.

Industrial property refers to patents for inventions, trademarks, geographical indications and industrial designs. Copyright, on the other hand, includes literary and artistic works, musical works, novels, poems, plays, films, drawings, paintings, photographs, sculptures, computer software, databases, and architectural designs.

We shall focus more on patents; a patent is a contract between the government and an inventor. In exchange for the disclosure of the invention, the government grants the inventor exclusivity, regarding the invention, for a specified amount of time. The normal time duration is between 14 and 20 years.Patent protection means an invention cannot be commercially made, used, distributed or sold without the patent owner’s consent.

To be patentable, the invention must satisfy basic requirements. These are:

• Novelty – The invention must be new and not known in the body of existing knowledge.  This body of existing knowledge is called the “prior art”.
• Inventiveness – It must show an inventive step and be non-obvious to an ordinary person skilled in the field of knowledge,  and
• Industrial applicability – It must be capable of industrial application (usefulness).

In addition, the subject matter of the patent must be accepted as “patentable” under law.

In many countries, scientific theories, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods or methods of medical treatment (as opposed to medical products) are not generally patentable.

NIPRISAN™

A case study of this is with the patent for NIPRISAN™.NIPRISAN™ is a herbal formulation for the management of sickle-cell disease(SCD), developed by indigenous researchers at the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja, Nigeria. The patent for the formulation was filed on the 21^st of January 1997 with the Office of the Commissioner of Patents and Trademarks, United States of America. The patent was approved in September 1998 with US Patent No. 5,800,819.

NIPRISAN, as claimed in the patent, is a herbal mixture extract, formulated from parts of four different indigenous plants (Piper guineenses seeds, Pterocarpus osun stem, Eugenia caryophylum fruit and Sorghum bicolor leaves) and an inorganic material mixed at specific ratios which has been shown to be safe and effective in the management of sickle cell disease, during a phase 1 and subsequent Phase 2 clinical trials.

The patent was filed for the process of formulating the preparation and not for the plants themselves as plants are not patentable by law.

FILING A PATENT

Patents are usually filed by patent lawyers, patent agents or patent consultants.  A typical patent application has to be filed with a patent office.  The fees charged by the patent office are usually not high. It is also normal to pay slightly more for the lawyer or agent who drafts the patent application. A maintenance fee is also paid at designated times within the life course of the patent; the same applies for trademarks.

In Nigeria, an application for patent is typically filed with the Registry of Trademarks, Patents and Designs, Federal Ministry of Trade and Investment.  Once the application meets the formality set forth by statute, a patent certificate is issued in due course to the inventor or assignee.  As noted above, an application for patent protection can and may be prepared by attorneys or agents.

A patent application must contain a complete history and description of the invention as well as claims for its usefulness. In general, the application is divided into;

• Title and Indication– this contains the background, novelty and indication of the technical field of invention.
• Description of invention – detailed description of the invention with drawings if available. This will include engineering specifications, materials, components and any other process that are vital to the actual making of the invention.
• Claims – this is the most important part of the application as it categorically states what the inventor is trying to patent. It is also the basis for determining infringements.

In Nigeria, patents are issued on a first-to-file basis and, when a patent is filed, an application number is given before approval. Once the application process is complete and filed, the status of the invention is subjected to the review and the applicant can assert a “patent pending” designation, implying that an application for patent protection has been filed on the subject invention. This status provides protection for the applicant until the application is approved or denied. On approval, a patent notice is published and is made available to the public for review.

The Patent Cooperation Treaty (PCT) – with over 100 participating nation states – was established to allow patent filing in multiple countries to be made in one office rather than filing in each separate country. A patent that provides protection in a particular country can be transferred to a different nation upon application to the relevant body.

By Pharm. Okwonna Nelson

“We shall not cease from exploration and the end of all our exploring will be to arrive where we started and know the place for the first time”.  T. S. Eliot

Research and development has “change” as its theme; a change driven by deliberate exploration – an exploration engaged by multiple parties who must find, within their limited resources and multiple interests, strategies to effect positive change in a mutually beneficial manner.

Today, innovation has become a highly prized “asset” and the future of organisations can be fairly predicted by their “innovation-capacity” rather than their “financial capacity”. Innovation however is far more deliberate than it first appears. Unlike the sudden flash of genius which “lay-people” would normally associate with creativity, innovation is hard work and demands both inspiration and perspiration, and always more of the latter.

In a recent debate on the Economist between Andrew Miller, Labour MP and Chair of the House of Commons Science and Technology Select Committee, and Terence Kealey, the Vice Chancellor, University of Buckingham, the two gentlemen debated on the role of public finance in funding applied research in the light of recent government funding of research stimulated economic growth. The major controversy was on who should pick the bill for the cash outlay required for innovation – the government or the industry, and if there is really any difference between applied and basic research. The debate threw up some interesting questions, but the lesson for some of us from Africa was that the Brits understood that the processes required for innovation to happen could not be left to chance.

Like a chemical reaction, Innovation requires some raw materials to happen but catalysts are often required to reduce the barriers to change and ensure that useful outcomes emerge – outcomes whose demand must be sustained, so as to achieve a self-sustaining reaction.

Many American educational institutions have devised unique ways to partner with the industry, to contribute to positive change without reneging on their basic functions. For some of them, such partnerships have yielded tremendous financial benefits and job satisfaction for the researchers. The emergence of the venture capital industry has also helped to create the required cash-pool needed to drive research and development, by providing funding for spin-offs and start-ups, whose core capital is their innovation.

In the biomedical industry, these concerns are quite intense; the model for drug discovery is changing, “me too” products may no longer be commercially viable.  Major companies are looking for more innovation from outside their own laboratories. AstraZeneca are publicly stating that they expect to buy 40 per cent of their science externally in the future. Merck and Pfizer say their growth will be from small product deals or acquisition of smaller enterprises.

For industry, the major source for these innovations would be from spin-offs firms created by those in the academia, and from product development deals with research organisations.  In this environment, research scientists and institutions can and should be more involved in evaluating the business potential of their science, as well as generating the science itself. There will be, indeed, real opportunities for business development and scientific enterprise.

To achieve this partnership effectively, there is need for both parties to act “responsibly”. The term: “Responsible Partnering” in the context of this essay refers to an initiative designed to improve the effectiveness of collaborative research and knowledge exchange involving the public and the private sector. Implementing these principles depends on appropriate organisational strategies and professional management skills. The Responsible Partnering initiative was launched in 2004 by the European University Association, European Association of Research and Technology Organisations, European Industry Research Management Association and Proton Europe.

Within the African context, it should be borne in mind that collaborative partnership between research and industry will benefit everyone; when university research seeks to solve the problems of the industry and to create new products and markets, we will be richer and happier for it. When our local research is targeted at our local challenges and is eventually turned into local products and services, the locals will be better off.

Collaborative research demands that both parties (research and industry) sit down to agree on the questions to ask and then proceed to find the answers, the problem often times is that the research and industry are miles apart, both in mind and in body!

To understand these principles, we would need to agree with certain facts:

1. Things have changed: universities and research industries are increasingly under more pressure to self-finance, and in many countries, the government and the tax payers are beginning to demand for justifications for the huge bill.
2. Much more than ever, knowledge inputs have become the critical factor of production; smart industries demand greater inputs from the academia, as business has indeed taken an academic garb. The pharmaceutical and biotechnology industry is essentially a smart industry – a knowledge-intensive industry.
3. Innovation is the lifeblood of this modern day industry and for the most part, especially in Africa, this innovation is somewhere in the laboratory or on some dusty shelf!

There are two basic principles of responsible partnering:

1. Maximise public benefit from public research: public money is invested in the creation of new knowledge and skills in public research institutions and universities, the benefit of these investments are seen only when this knowledge is disseminated and brought into productive use in the form of products and services.
2. Responsible use of public research: this begins with the recognition by both research and industry that their success depends on other’s contributions, hence both are realistic about their contributions and the importance of sharing responsibility for commercialising research outputs.

Public institutions must come to the comprehension that there is a burden on them to ensure public benefit from public investments and see their role in contributing to the development of new products and services, together with industry.

Guidelines that turn these principles into action

1. Treat collaboration strategically.
2. Align interests: this includes resolving factors that could be barriers beforehand; factors like intellectual property and project management issues, and adequate compensations.
3. Organise for lasting relationships: research collaborations which are more long term are preferred to research contracts which are influenced by different dynamics.
4. Provide the right professional skills: this will include academic, legal and business management know-how.
5. Establish clear intent.
6. Use standard practices and communicate regularly.
7. Achieve effective management of intellectual property.
8. Provide relevant training.
9. View innovation as a trans–disciplinary activity.
10. Foster strong institutions.

More detailed explanation can be found in the main text from which this essay was gleaned: “Responsible Partnering, Joining Forces in a World of Open Innovation: Guidelines for Collaborative Research and Knowledge Transfer between Science and Industry” October 2009.

Examples of such partnerships with industry could be between industry and university hospitals for the conduct of clinical trials, partnership with pharmaceutical research faculties for MSc/PhD studentships and post-doctoral fellowships. Collaborative research could also be conducted between private or quasi private research firms and a much larger industrial player.

Health care personnel are often not aware of their participatory role in health care research and development. We are often content to leave such deliberations to our colleagues in the laboratories. With a population of over 140 million people, less than fifty thousand practising doctors and ten thousand practising pharmacists, Nigeria cannot afford this observatory posture.

The term “research and development” connotes a systemic inquiry geared at creating something of worth or of improving the value of something in existence. In health care, this something could be of a preventive, diagnostic, therapeutic or palliative nature. It also includes the development of reliable data that would help in the management of health.

Our failure at research and development is evidenced by our low input in the nature and manner of health care interventions employed in our unique settings. In cancer management, this negligence, though not surprising, is very worrisome.

As the second common cause of death in developed nations and among the third leading cause of death in developing countries, cancer deserves special attention. In Nigeria, the most common cancers are breast, cervical, prostate, colorectal, liver and childhood cancers.

Data from the six cancer registries in Nigeria (which by the way, are poorly funded and hospital-based) show an increase in the incidence of these cancers. One of our major limits is that we are yet to fully understand that health care research and management is a discipline by itself. This point is important because our university system has made it such that we must do health care research; the next step is to manage these efforts effectively.

Research management embraces anything that health care providers, research institutions and universities can do to maximise the impact of their research activity. It includes presenting research findings in a manner that its application is visible, assistance in identifying new sources of funding, the development of efficient frameworks for costing projects and negotiating contracts with external sponsors. It incorporates project management and financial control systems. It also involves help in exploiting research results – through commercialisation, knowledge exchange and dissemination to the wider society.

Though there are no perfect solutions to the problems of research management, this article however seeks to present some thoughts for consideration. These would be within the ambits of the following:

• Attitude
• World View
• Capacity and
• Frameworks

Attitude

It is easier to do nothing about Nigeria’s health challenges until one is affected personally. One need not have a relative with cancer to dedicate skills and time to research. One should not also believe that we can contribute nothing of significance.

It is in the opinion of this writer that the most beneficial medications in use in Nigeria today were developed with the same level of skill and technology that are currently at our disposal. Drugs like Metformin, Paracetamol, Sulfonylureas, Digoxin, Artemisinine, Quinine, Chloroquine and Sulphadoxine did not require the kind of ultra equipment that we are yet to have in Nigeria. Yet, these common medications are the main stay of therapy in Nigeria. Research has shown that newer generations of medications are not necessarily more effective than these old warriors.  The point is that we need not think that our inadequacies are sufficient to rob us of any capacity to make meaningful contributions, especially to cancer management. It is my personal submission that we have all it takes to make breakthrough findings in Nigeria.

It is such an attitude that would persevere against odds to seek models and strategic partnership for an effective output. Such attitude, it is believed, would drive collaboration and foster result-oriented research. This becomes even more important if we should consider that the most effective preventive and therapeutic medications for cancer were plant-derived.

World View

Central to a researcher’s theorem is his view of the world and his role in it. A world view that sees man as a product of chance and matter, or of soil and blood as the Nazis put it, as opposed to that of a created being, would propose different questions and expect different kinds of help. A researcher that believes in an Adamic mandate of rulership and dominion, and of the goodness of the Creator, should believe that the Creator has not kept the answers to the questions too far from man. The problem is that in Africa, we don’t carry our beliefs to the laboratory or even to work; unfortunately, the African believer has been made apathetic, rather than ardent by the things which he believes.

To drive an effective cancer management research and development initiative, we need to believe that the forces of good are in our favour and are ready to help us. We would need to also question some standard approaches, with respect to their coherence with that which we believe to be true.

Capacity

Like we mentioned earlier, the few health care professionals in Nigeria who are practising are so overwhelmed with work that few have the time or the wherewithal to design and implement an effective research strategy – considering that the rewards for such commitments are long in coming. The universities and other research institutions have therefore become the only hope for an intervention. These institutions, which are mainly public in nature, have also suffered from the same problems that have hoodwinked the Nigerian economy. The paucity of strategic vision and funding is such that these institutions have been unable to contribute much.

In a shrinking funding-market where everything is going private, health care personnel in private and public institutions who have the right attitude and world view must adopt certain frameworks to drive research management.

Frameworks

The first framework, I believe, is in the purposefulness of a research undertaking. The prevailing research for research’s sake cannot take us anywhere. Of course, there is need for basic research; but in Nigeria, what we have is mediocre. I have seen many research ventures that, though may have bogus “rationales” will make no meaningful contribution in practice, especially when compared to the opportunity cost of performing such. Take, for an example, a research to evaluate the effects of trace metals on the antimicrobial effect of chloramphenicol may sound quite nice, but in reality, it could be a mediocre effort to obtain a degree.

In practice, a post-primary clinical setting that does not inculcate a system of research and development is quite inadequate. My point is that health care providers must inculcate systems that allow them to ask certain questions, evaluate certain assumptions and contribute to the body of knowledge. A teaching hospital, for example, must create a robust knowledge building and sharing system that is both daring and ethical. We cannot afford to leave this onerous task to traditional research institutions alone. The private sector is more adept at finding and managing finance. She must rise to the challenge of cancer research and development. These would involve seeking and getting approvals for clinical trials; driving Public-Private Partnerships; soliciting to increase the willingness of hospital administrators to conduct clinical trials on herbal remedies; commitment of huge funds to research and development; and active collaboration between research and industry.

Nelson Okwonna (B.Pharm)

It was Bonaparte that said: “Leaders are dealers in hope.” By “hope” he was referring to something not yet seen for which the leader tasks himself and his followers that they may perhaps attain. The not-yet-seen dimension of hope could be akin to innovation. It could be an idea of a new drug formulation, new medical device or a business strategy. The leader may not be the inventor of this new idea but he is the individual that perspires till this new idea becomes reality.

With this background, I hope you will understand my thoughts on the Nigerian retail health care industry. It is not necessarily an innovative thought but it is a leadership challenge. It is a challenge that has lived and died in the minds of many pharmacists, doctors and investors. The reason for these abortions, I believe, is for the failure of research and development to deliver the winning strategy. Research and development is not just what we do in the “laboratory”. The best laboratories are in the inner recesses of our minds and in the classrooms of everyday life. In it, many a professional have asked the question: “How can I develop a thriving retail pharmacy or hospital chain in Nigeria?”

Note that we are now researching, the thinking cap can now come out. Thank you.

The need for increased profitability and job satisfaction has made many owners of pharmaceutical premises to seek avenues of improving their reach. There is also the patient-benefit angle to this. Patients would benefit more from successful chain pharmacy or hospital services due to a level of standard of care that would be offered in those premises. With a standardised privately owned chain service provider, the service centres would enjoy an increased level of public confidence. The centre could also have a central patient information system that allows patient data to be accessed from different “service centres” of the same chain.The chain would also buy products at much reduced costs and this I believe would be the ultimate game-changer in the drug distribution system in Nigeria.

Regardless of the motivations to take on this path, however, the challenges are many.

Like I said, this is an idea that lives in my mind. It is not necessarily new. Leadership begs that it doesn’t die there. In a recent Pharmanews management workshop on “Effective Disease Management in Resource-Limited Settings”, Dr. Femi Olaleye proposed that chain pharmacies and hospitals are the solution to meeting Nigeria’s health care needs at the primary and secondary care levels. He proposed that these chains need not maintain an “egalitarian” posture but should rather have the capacity to meet basic needs at these levels of care. He was echoing my thoughts quite clearly.

His proposal begs for leadership. Leaders are saddled with the responsibility of finding “correct” solutions and disproving the greater majority who are avowed sceptics. So, how can this seemingly “doubtful” contraption of a chain pharmacy or hospital work in Nigeria?

One could say that the major reason the chain option has not worked in Nigeria is that the individuals that can make it work have something more profitable to do with their time and businessknowledge. If you have three premises, handling supplies and making a whole lot of money, why bother with many service outlets, pilferage, terrible staff and negative operating environment?

The maintenance cost of such a contraption is not necessarily the cost of petrol but the managerial cost; the headache may not be exactly worth it. The questions then, are:why and how can I create a profitable management system that assures accountability and control at the centre, yet with little complexities? I may not be able to answer the “why”; I will try the “how”.

The first solution is to recognise that the strength of the chain service system is in the chain. The brand must be invested in or it will rise and fall with the whims of the professional managing it. So, the first job of the leader is to create a system that is big enough that it is bigger than any individual. In other words, the chain should stand for something – niche service provision. A pharmacy chain, for example, has to stand for something. The strength of Walmart is in their pricing. You could borrow that.

In a service industry like ours, the professional manager is a knowledge worker and is essential for the smooth operation of the business. In such a system, when well-managed, the brand is strong enough that business doesn’t necessarily rise and fall with a change in the professional manager. Also, since a lot of funds would be required, investors would be a welcome idea. An effective strategy is one that factors all these interests in a win-win situation.

I am biased towards a management system that tinkers a bit with the traditional ownership structure. Considering that management need not bear all the cost of the operation if it can maintain control over the basic structure which is essentially the supply of professional labour, the brandmanagement and the supply of the products, then a modification of the franchise option becomes very viable.

A structure where the franchising firm is responsible for managing the professional labour and product supply, the franchisee is more or less an investor with a degree of management capacity, depending on the arrangement. In this system, the professional manager could get a degree of ownership either as equity (with time) or asa percentage of profit with well-defined exit strategies for both manager and investors. The franchisor seats back to promote the brand, manage the managers and find new investors for new outlets.

Within this framework I am trying to describe or something similar to it, I believe a leader can find the wisdom and strategy to drive this idea. He, like all leaders, must do a little work of indoctrination. He would have to re-educate himself, his managers and investors to make this happen. He would need to be believable, and need remove some of the frills that make the practice expensive to maintain.

Like every good idea (this is my sincere opinion of this), this idea can be found to be bad by experimentation.Remember, we are still in the laboratory. Hope you came with your lab coats?

Thanks.