‘Government Should Increase Spending in the Health Care Sector’

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By the very nature of their training, lawyers can excel in any field of human endeavour. Many lawyers have in this regard distinguished themselves in various fields, deploying legal skills creatively. Mrs. Vivian Osayande who is the Head of Legal, Africa Cluster, Novartis is one such Nigerian lawyer. In her discourse with May Agbamuche-Mbu, Jude Igbanoi and Tobi Soniyi, she expounds on the intricacies of managing the legal and regulatory compliance requirements of a multinational organisation such as hers which spans across several jurisdictions in Africa, the role of in-house counsel in corporate organisations and sundry professional issues.

Being the Head of Legal services in the African division of a global healthcare company requires an in depth knowledge of the pharmaceutical industry and a good grasp of commercial law. What has been your experience so far?

In-depth knowledge of the industry and a good grasp of commercial law are valuable qualities to have. There is also the need to have good dispute resolution experience, sharp negotiation skills as well as advocacy and people skills, being that it often involves internal and external stakeholders. The most important skill to have is a good understanding of the business and this is applicable to any industry, whether it is Pharmaceuticals as in this case, or telecommunications or Oil and Gas, the Head of Legal or General Counsel is only as good as they know their business, their sector and the workings of their industry. Thankfully, this part can be learned quickly depending on the individual’s humility, open mindedness as well as learning agility.

It has been a huge learning curve for me and a great opportunity to work in a truly multi- national company that is driven by Patient-centricity and strong values such as innovation, courage and collaboration. I have experienced diversity and inclusion at its best and it has also been a good opportunity to work in an industry that directly impacts human life and promotes wellbeing. I have found my major role to be that of an enterprise connector, bringing several aspects of the business together through legal advice.

A major professional mindset shift has been that of decision making and calculated risk taking. In my previous roles, it was possible to share different legal options with the client and allow their legal teams to take the decision but now, there is often an urgent need to take a courageous decision fairly quickly. This also brings to bear, the burden to not only do what is legal, but more importantly, what is right.

Legal Support and advice across 46 African Countries would no doubt be a daunting task. Given the multifarious challenges relating to drugs manufacture, distribution and administration in Africa and the fact that legal regimes vary from country to country in Africa. How do you cope with this challenge of working in various jurisdictions with different legal systems?

The company has a great cross- functional team, where employees have a passion for Patients. The team, both within the company and via our external legal counsel Africa panel has been very helpful. As you noted, our geographic spread means, legal regimes are quite different. Complying with local laws in every jurisdiction is a given for us, we therefore rely on the expertise of local legal teams for support. We work with good business minded law firms in all the countries and factors such as language, poor travel connections, infrastructure, and even under developed legal framework in certain instances, which would have ordinarily posed a challenge, make the task exciting. The overall impact on the business outcomes and the lives of the Patients we are called to serve, make it even more rewarding. Africa is on the verge and the threshold of possibility is endless so it is indeed an honour to be able to traverse the beautiful geography, experience the rich culture and encounter the intelligent people.

The role of Compliance Officers in corporate organisations is taken for granted in Nigeria. With the benefit of your experience at Novartis, can you explain the importance of a Compliance Officer?

From my work experience I do not agree that the role of Compliance Officers is taken for granted in Nigeria. Many companies, including ours have invested significant resources in building a strong and sustainable Compliance culture and attracting the right talent to oversee the Compliance Officer role. The era of the Compliance Officer being merely the approver of projects and policing the organisation is over. The only businesses that are sustainable in today’s reality are those who have made this transition about this important function. The FCPA and the UK Bribery act both have extraterritorial reach; however that is not the only reason for this shift. Shareholders and other stakeholders are demanding more accountability from businesses.

The Compliance Officer role is one of the most important roles in an organisation with the primary responsibility being to ensure that everyone within the organisation drives the business with integrity. The role has evolved over time moving from the back office to the boardroom. Compliance is a key business and management function. Someone once said that an effective Compliance Officer is one who can persuade and motivate the business to do the right thing and to be truly emotionally invested in the aims of the compliance program.

In certain organizations the role of in-house Counsel is merged with that of the Compliance Officer. In your opinion can an individual combine both roles successfully?

Whether one individual can combine both roles successfully should be determined by the scope of responsibility on either task whether on the compliance side or the legal side. This is a decision that is typically driven by business needs. During the course of my career I have seen instances where this has been fused successfully and instances where it has been separated successfully. There is no hard and fast rule. It is possible for a lawyer to be the Compliance Officer but it is not compulsory for the Compliance Officer to be a lawyer. The Compliance officer could be anyone with relevant business, life sciences or other relevant subject matter experiences.

The delicate relationship between in-house counsel and external counsel continues to be a subject for discussion because of the varied and distinct perceptions both groups have of roles and work deliverables. How should external counsel approach their role with in-house counsel?

The role of external counsel in providing support to in-house counsel cannot be over emphasised; the sheer scope of external counsel experience, dealing with several clients across several industries increases the value that they bring to the in-house legal department. Some of Africa’s finest external lawyers across various law firms provide us with strong support and we consider them our partners as opposed to mere service providers. That said, what will amplify the value that external counsel brings is their ability to take the time required in understanding the client’s business, peculiar needs and particular instructions in order to tailor their advice/recommendations. This is one area where knowledge of the law is not enough. Communicating the information in a simple, clear and timely manner is very helpful. Picking up the phone to discuss a query can quickly solve the puzzle as opposed to the traditional multi- pager memo.

Both sides must bear two things in mind:

• First is that with the state of the global economy, in-house legal teams world over are under pressure to manage legal spend therefore the problem solving approach must be innovative and cost saving.

• Secondly in-house legal teams are getting leaner so the dependence on external counsel for value based support is on the increase and so when these two things are taken into consideration it is a win-win.

Considering your experience in other African countries regarding access to affordable medical care could you suggest possible ways government can improve access to affordable health care in Nigeria?

The simplistic answer would be to ask that the Government increases health care spend in order to put the requisite infrastructure in place but with the global drop in Oil prices and other factors which have led to huge reduction in the Government’s earnings that would be far-fetched. A multi-faceted approach would be required. Such an approach would focus relentlessly on the priorities and outcomes that matter. Government cannot afford to focus only on the supply-side interventions—for example, medical professionals, commodities, and facilities but must also work to close gaps in demand for health services which are occasioned either by cultural barriers or even high levels of illiteracy. We must bear in mind that the present reality is that Government alone cannot close the huge gaps we experience in the Nigerian health care system. However, it is pivotal that it takes the lead to foster sustainable partnerships as in other countries, there has to be a collaboration of all the key stakeholders to systematically eliminate barriers to access Public Private Partnerships are inevitable.

In my opinion another major thing Government can do at this time is to work towards creating a stable legal framework for critical issues such as healthcare logistics and supply chain management systems. We cannot over emphasise the need for stable legal framework. Take a look at the National Health Act, which was passed in 2014. It has the potential to deliver public health improvements and the attainment

of Universal Health Coverage (UHC). Driving the implementation of such an initiative to optimum levels is something else that Government can do.

Could you enlighten us on Novartis’ corporate social responsibility initiatives in Africa and Nigeria in particular?

Creating Patient Access to innovative healthcare in Africa is at the top of the Novartis agenda.

In 2015, a USD 1 million Health Education & Capabilities Fund was established to help finance internal projects focused on health education, disease awareness and capability building, primarily in Africa. Novartis is also contributing to building scientific and clinical capabilities in emerging countries through the Novartis Next-Generation Scientist (NGS) and Visiting Scholar (VS) programs. Each year, 20 NGS interns and as many as 10 VS from across the developing world are selected to carry out research projects using state-of-the-art techniques and equipment that can also be implemented within their local infrastructure. Since 2010, 135 young scientists and clinicians from 21 countries across Africa, including Nigeria participated in these programs. The programs have contributed to peer-reviewed publications, presentations at international conferences, the advancement of local healthcare infrastructure, and the creation of an international network of scientific and clinical leaders in emerging countries.

In Ethiopia, Novartis Sandoz collaborated with local authorities in East African countries to set up the first regional bioequivalence center, providing capital and technical support. The center ascertains the bioequivalence of generic drug products against those of the brand/innovator products as per the specifications of the World Health Organisation. It provides laboratory and clinical research skills training to local communities, and helps strengthen health policy controls in the long term. Supported by The Novartis Research Foundation, Novartis has entered a research partnership with H3-D, the first fully integrated drug discovery and development center on the African continent, affiliated with the University of Cape Town in South Africa. The goal of the center is to educate the next generation of African scientists and to work on diseases that affect people on the African continent.

Nigeria is hugely important to Novartis, since 2002 over six hundred patients in Nigeria who cannot afford their treatment for chronic myeloid leukemia, receive this life changing cancer therapy at no cost. The Glivec® International Patient Assistance Program (GIPAP) is a public private partnership supported by Novartis along with the Max Foundation, Axios International and other local Non-Governmental Organisations. Recently, as part of the Life Gift Transplant program, Novartis partnered with the Federal University of Sao Paulo, Hospital do Rim e Hipertensao- in Brazil and Lagos State University Teaching Hospital (LASUTH) for upscaling of capabilities and skills acquisition regarding renal transplantation. This project was implemented to encourage appropriate collaboration between LASUTH and the Brazilian Hospital and to support best standards of care and practice with regards to legal and ethical ramifications of renal transplantation. There are other educational initiatives that Novartis has undertaken to improve the knowledge of healthcare practitioners in several other therapeutic areas including cardiovascular medicine and ophthalmology. Novartis has also recently partnered with the Pan Africa University, Lagos Business School and several independent Pharmacies to train over 70 Pharmacy assistants on advanced Customer Service with a view to build capability. The journey is ongoing.

NAFDAC recently reported that 65% of drugs on pharmacy shelves across Nigeria are fake and adulterated. What is Novartis’ strategy for protecting its brand and products in Africa

Novartis is committed to preventing the counterfeiting and diversion of our medicine and actively collaborates with partners in government, industry, law enforcement and the public health sector to implement strong integrated anti-counterfeiting measures and to communicate the health risks of counterfeit products to patients. Novartis uses anti-counterfeiting technologies which are very simple to use but difficult to detect and copy. Working with international and local authorities and industry partners we have had much success in reducing theft and disruption to the legitimate supply chain and we continue to explore and implement additional product security technologies.

Through these efforts we aim to protect patients from counterfeit medicines and to ensure our patients receive the high quality medicine they expect and deserve. Recently, we were commended by NAFDAC for partnering with the agency.

Packaged food and drugs are registered with NAFDAC before they can be offered for sale on the market. Having worked in different regulatory agencies in different countries, are there procedures or methods NAFDAC can adopt to improve the process of product registration?

I would like to commend NAFDAC on their product registration processes. The automation of processes and the availability of information online have improved the user experience for companies who interact with NAFDAC. I am looking forward to further improvements and innovation as their commitment to assess and improved processes would ensure that they are in line with global standards.

The Ease of Doing Business in a country is one of the factors investors consider when making investment decisions. In your opinion how can government improve the ease of doing business especially with regards to the Pharmaceutical Industry?

The government should be vested in improving the ease of doing business to encourage entrepreneurship across the Nigerian business landscape.

Under the Ease of Doing Business index, getting a higher ranking indicates that a Country has better, usually simpler, regulations for businesses and stronger protections of property rights. Many factors are considered in getting to this conclusion. Examples would include what the duration of court procedures should be and what the optimal degree of social protection is. What government could do is to intensify efforts to improve the many indicators. It cannot be limited to how quickly it is to register a local entity, but must be broadened to include often neglected factors such as resolving insolvency, enforcing contracts, taxes and even obtaining permits and licenses.

Nigeria’s vast natural resources outside of Oil, human capital, young demographic population and the undying resilient spirit of the average Nigerian continue to make it an attractive business hub in spite of the present difficulties. Even though its current ranking on the index is low, Nigeria represents the N in the MINT acronym which was coined to classify what is viewed globally as the emerging economic giants. How quickly we collectively work on the premise that in spite of the present economic situation, Nigeria has everything it takes to truly emerge would determine how quickly we live this reality.

The legal profession in Nigeria has a clearly distinct and enviable reward system for lawyers in litigation, who are awarded the coveted rank of Senior Advocate of Nigeria. In the past few years, lawyers in corporate and commercial practice have been agitating for some form of recognition in their own field. Given the fact that the legal profession in Nigeria is fused, do you see any merit in this proposition?

The Senior Advocate title is basically a perk of the Bar which in my view is great. It is a reward for people who have distinguished themselves in advocacy. You might argue that advocacy skills are hard to define and to distinguish from those required for a competent lawyer who does not get his feet in the court room and that in a profession that is encouraging people to avoid going to court whenever possible by embracing conciliation and mediation, good negotiators should get the recognition too. While there may be merits to that argument, in my view, considering that the criteria for becoming a Senior Advocate still revolves mainly around the number of cases a lawyer has done in courts of superior record, I find the exclusion of corporate commercial lawyers justifiable. That is not to say that I do not think that corporate and commercial lawyers should be recognised, I just don’t know that the appropriate recognition would be the conferment of the Senior Advocate title. It would be interesting to see how that would play out because the criteria would need to be radically changed and even the benefits of wearing the Silk and getting express audience with the Judges would not be relevant to the commercial lawyer in his day job. I am not a crusader for the proposition but we can’t ignore the clamour and maybe it then becomes important to review the current conferment framework.

Over the past few years, Arbitration has witnessed an unprecedented growth in the African continent because of its advantages over Litigation. However after the successful conclusion of the Arbitration process, counsel more often than not initiate proceedings in court or challenge the arbitral award thereby making the process less effective. In your opinion what can be done to prevent counsel from seeking relief from the courts after submitting to Arbitration?

The federal Arbitration and Conciliation Act Cap A18, Laws of the Federation of Nigeria 2004, has already made provision to ensure that Counsel cannot indiscriminately seek relief from the courts after submitting to Arbitration. Courts will generally decline jurisdiction and would not intervene except as has been clearly provided for under the Act. The Courts are meant to support the process where necessary, for example where there is a need to issue a subpoena to compel a witness to attend etc. Where a party brings an action in court with a view to frustrate the arbitral process, Nigerian law is to the effect that the other party may ask the courts to stay proceedings as far as he has not taken steps to defend the matter. In practice, Nigerian courts are generally supportive of the arbitration process and are reluctant to set aside awards where parties have agreed to abide by the decision of a tribunal of their own selection, unless it is shown that there has been something radically wrong and vicious in the proceedings.

What seems a bit ironic is that the procedure for enforcement of arbitral awards in itself still has the tendency to fall prey to tactical delays. In my view, this procedure is expected to be summary and not protracted. The only reason it becomes necessary to enforce the award in the first place is because the other party has not simply accepted it. So continuing to rely on the traditional rules which require the use of Originating Summons and Motion on Notice for enforcing arbitral awards is an avenue to open the process up to several delays. Several practitioners have called for a more simplified and specialised process and I am supportive. It will be good if we took a cue from other jurisdictions like England and Brazil in this regard.