Legal and regulatory considerations for intending businesses/start-ups.
The United Nations prioritizes Health amongst the Sustainable Development Goals. Goal 3 is tagged ‘Ensuring Healthy Lives and Promoting Wellbeing for all at all ages. Regarding sexual and reproductive health, the United Nations hopes that by 2030, it would have ended the epidemics of AIDS and other communicable diseases as well as ensuring universal access to sexual and reproductive healthcare services around the world. Although introducing technological inventions into the healthcare systems and processes is not highlighted as one of the targets or indicators towards achieving this Sustainable Development Goal, Technology and its overarching influence has hugely impacted the healthcare industry. The sitting Director-General of the World Health Organisation, Dr Tedros Adhanom Ghebreyesus confirmed this position when he alluded the role of technology in achieving universal health coverage.
Without delving into the intricacies of medical practice and public health jargon, I’ll highlight some of the various opportunities which may be considered in bridging the gap between sexual and reproductive health challenges, needs and solutions and thereafter provide an insight into some legal and/or regulatory considerations to be made in establishing these business ventures. The inadequacy of healthcare practitioners in some regions and areas of the country is a peculiar challenge: It is no news the ratio of health practitioners to patients is alarmingly high and particularly, the stigma or shame that is attached to nursing a sexually transmitted disease or even HIV/AIDS may discourage patients from accessing medical care or approaching healthcare facilities. This challenge throws up the opportunity for Telemedicine practice.
Telemedicine provides an opportunity for remote consultation with specialist practitioners and obviates the need for direct or onsite consultations. Telemedicine can be used in many fields especially in sexual and reproductive healthcare practices which requires some form of specialization. A number of private sector stakeholders have undertaken telemedicine-related endeavours. This innovative practice solves the problem of fatal delays, ensures access to healthcare in rural areas, reduces the number of patients in Waiting Rooms and improves efficiency. There are prospects for its success, and there is no doubt that telemedicine would improve healthcare delivery in Nigeria.
Furthermore, the development and use of intuitive mobile health apps have proven to be another initiative for improving healthcare delivery. They provide flexible options for both patients and practitioners. While some apps may be developed to help create better health awareness for patients, others may be used to facilitate communication between patients and practitioners as well as amongst practitioners within or outside specific jurisdictions (in cases of referrals). These apps may be adapted for tracking doctors’ appointments, improving diagnosis, maintaining personal health records, recording logs of consultations and visits, keeping records of drug administration and prescription as well as providing access to drug information. They can also be used for the management of chronic healthcare issues, medical references and medication management.
Additionally, the several treatment technologies that have been put out for commercial use have also improved management of sexual and reproductive health challenges. As with all business endeavours, there are legal and regulatory regimes to consider and comply with in order to avert the consequences of non-compliance which may be in the form of regulatory sanctions or monetary penalties. Whether one intends to set up a telemedicine platform, carry on the sale of medical devices or develop an intuitive mobile application software for patients or practitioners, It is imperative to note that there are varying regulatory and legal considerations that apply to individual business ventures or commercially exploitable ideas.
Before establishing any start-up, the desired name for the brand must be carefully taken into consideration. This is as a result of the issues that may arise in the course of business such as infringement of other existing trademarks, use of descriptive trade names, or likelihood of confusion as a result of similarity in trade names. For instance, it will be unheard of to register Demzor as a healthcare brand when there is a company in existence called Emzor. Such name will be deemed confusingly similar to Emzor and this will attract multiple lawsuits against the proprietor of Demzor.
Once the brand name has been determined, the next step is to reserve the said business name. This is the first step in company registration, and it is a necessary step because it provides an opportunity to check whether your proposed name is available for use. Names are usually reserved for a period of 60 days and upon obtaining information that the proposed business name is available, you can proceed with the registration of the business.
The rest of the registration process will vary depending on whether the proposed business will be registered as a Company or Business name. There are a number of similarities in both registration processes but still, a host of differences. It is advisable to speak with an experienced professional, particularly a legal practitioner in order to be properly guided on what form of identity your business should have.
Considering the fact that the healthcare industry is a highly regulated one, there are necessary approvals, permits and licenses that must be obtained depending on the subsector of the business. It may be argued that there is no approval requirements for technology-enhanced start-ups like telemedicine businesses, developers of health applications, it is important to note that there are regulatory requirements with authorities such as National Information Technology Development Agency, Corporate Affairs Commission, Consumer Protection Council, as well as compliance with Code of Medical Ethics (in the case of e-businesses being run by medical practitioners) which must be taken into consideration.
In conclusion, it is imperative to note that in doing business, there are a number of legal and regulatory considerations to be considered and complied with in order to avert crisis. As start-ups, there are teething problems which will be encountered but regulatory issues must not be one of them as regulators have become more vigilant and proactive in a bid to sanitise the business regulatory environment of the country.