Slide 1 Welcome to Chapter 3 The following chapter is called Legal Requirements of Fertility Centers and IVF Clinics The author is Miguel Moreno.
Slide 2 At the end of this session you should know which basic legal requirements IVF Clinics and Fertility Centers must consider before their foundation, during their operation and throughout their daily activity. Once this unit is concluded, you will have a complete idea about the legal necessities at the IVF Clinics.
Slide 3 The first part of this chapter deals with legal aspects of the foundation process. The second part deals with legal aspects of the daily business in an IVF Center.
Slide 4 First of all, a previous study of the country's assisted reproduction legislation where you want to establish and of all the rules related to the activity should be done. In the absence of legislation in that country, the existing restrictions should be considered. The next step will be to set which treatments are authorized and which ones are not. It is important to be aware and make a previous analysis of the country s social conscience. The different treatments that are being offered by other IVF Clinics should be known, in order to avoid conflicts with these clinics or with patients. Eventually, the treatments that are going to be offered to patients and those which are not need to be identified.
Slide 5 It is important to be aware of all the legislative initiatives to discern the possible future legal framework, which will allow you to be ahead of problems or complicated situations and provide solutions. It is essential to know the legal requirements and authorized bodies for the opening of an IVF Clinic as well as the demands for professional practice. You also need to study the labor and fiscal rules of the country.
Slide 6 Regarding the building, you must identify the appropriate location. The next step must be to verify the urban development use of the plot and the building to confirm that the IVF Clinic can be situated in the chosen building. You need to check carefully the internal rules established in the Charter governing the neighbors associations of where the building is located to avoid restrictions that impede the development of the activity. Whether to purchase or to rent the building should be decided. If needed, you will have to seek financing.
Slide 7 The architect must develop the plans and costing of the fitting out of the building, in strict compliance with all the governing rules. The works execution of the building must be carried out in compliance with planning regulations, installation and HVAC rules for the cryopreservation of cells and embryos. Respect to environmental rules, especially those related to noises and vibrations of the installations and equipment. A price must be set with the architect and the constructor for the building s fitting out, with an execution period, duties, responsibilities and penalties in case of delays in the works. It is advisable to demand a bank guarantee that covers the builder s works abandon. It is important to require that the architect and/or the constructor have a works policy and a civil liability policy.
Slide 8 The medical activity will be developed by a businessman through a trading company. What is the most suitable company structure for the principal activity of an IVF Clinic should be studied. For the setting up of the company, you will first have to notarize the articles of incorporation. These articles must include at least: corporate name -previous reservation of possible names-, shareholders: number and complete data, corporate purpose, corporate address, operations term, capital stock, and governing body.
Slide 9 The governing body of the company can be: a sole administrator, joint and several administrators or a Board of Directors. The corporate resolutions will be adopted by the shareholder's meeting. Depending on the resolution, the meeting will be ordinary or extraordinary. The company needs to be registered at the Trade Registry. A company involves different corporate obligations that need to be carried out during the daily activity such as minutes, certificates, up-dating the shareholder s register, etc. The corporate acts that may be necessary are: granting power of attorneys, capital increases, capital reductions, share purchase, and sale agreements.
Slide 10 A project architect/project manager agreement and a contractor/works execution agreement must be described before starting work. Any natural or artificial person that takes part in the process is considered to be a construction agent. Their obligations stem from the legislation and agreements signed. In the different contracts or agreements the prices must be fixed, the services should be detailed and the terms of the execution period should be established. The signature of the above said contracts allows responsibilities of the building agents assigned, to demand non-fulfillments. Guarantees and insurance policies must be taken into consideration. Prior to the works execution, a building permit must be applied for.
Slide 11 The licenses or authorizations required for an IVF Clinic are the following: building permit, activity license, and health license. Prior to the operation of the IVF Clinic. you must apply for a license. Then and previously to the opening, the operation license must be obtained. Furthermore, a health license is needed. Other applications are Patents and Trademark Registry and the tracking, renewal and defense strategies of the trademark. Copyright register, studies, research, publications, and further know-how are also required.
Slide 12 Precautions against the activity risks should be taken, by subscribing a complete civil insurance policy. It is an essential issue for the activity development. The most advantageous terms and conditions need to be negotiated. The risk description of the civil insurance policy needs to be in general and in particular. All the employees and the professionals of the IVF Clinic need to be included in the policy. Arguments should be ready to defend and face patient s claims, complaints and lawsuits for medical negligence.
Slide 13 Other policies that are necessary for the daily management of an IVF Clinic are: Policies that protect and assure the building. These policies must cover all the possible damages. Policies that complete the protection for employees and directors with particular policies. Policies that are related to data protection. Specific policies for clinical trials. Frequent meetings with insurance companies and insurance brokers should be held. And in any case, negotiate incidents in front of the insurance companies and establish a defense against patient's claims.
Slide 14 Data protection is capital in the health scope. People's health data are included in the IVF Clinic s data bases and medical histories. Health data deserve a higher protection and confidentiality. In reproductive medicine, most of the medical histories are shared. This means they refer to two people; in these cases, the Fertility Center must adopt additional security measures. The computer technicians must register the data bases, where the medical history is included, before the relevant authority.
Slide 15 For data protection, you need to take into consideration: The drawing-up and development of protocols for our professionals and employees that guarantees the confidentiality of the personal data and the medical history content. Extending the protection to the website, making the corresponding legal warnings according to the legislation and taking the precautions that are necessary to protect the data provided. Information about the terms on how the personal data is collected. Purposes and mechanisms so that the user can exercise his access, rectification and cancellation rights, in an easy and accessible way.
Slide 16 In regards to informed consents and protocols the following should be considered: when signing the informed consent (IC) the patient accepts the medical treatment, once the implications have been explained. The IC has to be in accordance with local rules. The legal issues of the IC should be taken into consideration. Advise during the process of signing the IC. Periodic supervision of the paperwork addressed to patients, donors and suppliers should be performed. The necessity to fulfill all the protocols related to patient s assistance, treatment procedures, surgery procedures and payments should be considered. Patient s absence of information should be avoided.
Slide 17 The content of an informed consent covers four essential parts of information which are visualized as columns here: legal information, ethical aspects, a description of the economic conditions, and biological information.
Slide 18 It is important that lawyers take part in committees that support the Clinic s activity and others established by Law. The participation in these committees allows legal point of view in the mentioned multidisciplinary committees and the analysis of the convenience and legality of certain treatments in emergency situations.
Slide 19 Here is a brief consideration of each committee: 1. Bioethics committee decides whether the medical treatments violate any bioethics principle. 2. Research committee evaluates and approves different research projects. 3. Care committee establishes the guidelines and protocols of the medical care provided to patients, and 4. Management committee sets the business strategies and administers the IVF Clinic.
Slide 20 The legal consultancy solves all the questions, doubts, and issues raised by professionals, employees, and patients. It also provides general legal advice and in particular: labor scope. Application of collective agreements, sanctions, and issues referred to the staff recruitment and patient s complaints. The legal consultancy must also solve all those issues related to the main activity of the IVF Clinic such as: appropriate interpretation of the assisted reproduction regulation, drawing-up IC and data protection documents.
Slide 21 Other areas where legal advice is essential are: civil, commercial, tenancy agreements, coordination of the license process, training and teaching, outstanding debt claims, drawing-up all kind of documents before civil services and referred to commercial law: setting-up companies, capital increases and reductions.
Slide 22 Around 90 percent of the medium and big companies from the health sector have their own legal consultancy, usually called in-house lawyers. This internal system has many advantages compared to the traditional system, such as: immediate answers, specialization according to the company s needs, crisis prevention and resolution, and important expenditure savings for providing the aforementioned services. In particular, this internal system in IVF Clinics has other additional advantages such as: knowledge and experience in a recent area of the law, which is in constant change and where very few specialists are found. Furthermore, experience and know-how are accumulated.
Slide 23 Depending on the advice necessity of an IVF Clinic and its professionals in-house lawyers have a central function in delivering immediate answers and coordinating the cooperation with external legal consultants. External consultants might be necessary in special situations.
Slide 24 The main tasks of an in-house lawyer are described here: More than 40% of their workload consists of the daily management of different issues as well as giving advice to other departments and to the government body. The controlling of the staff recruiting, the service contracting process and the coordination with external consultants are also a part of their main tasks.
Slide 25 You should have a complete idea about the legal necessities at the IVF Clinics. The work must be structured in two phases: previous study until the development of the activity and day-to-day management of the IVF Clinic. The initial phase will determine the economical profitability of the IVF Clinic and its development. In case it is not adequately planned and executed, it will hardly be amended later. The preliminary study of current legislation is essential. The daily activity of IVF Clinics requires the involvement of several committees.
Slide 26 The continuous legal support to the IVF Center is essential in this business sector both in its initial phase and in the day-to-day management. That is the reason why most health centers choose to have In-house lawyers. Only in special situations external lawyers are used, therefore, in-house lawyers reduce expenditures.
Slide 27 For further reading the following websites and papers are recommended.