ETHICS AND RISKS IN BIOTECHNOLOGY

ETHICS AND RISKS IN BIOTECHNOLOGY

By

Student’s Name:  Bundi Clinton

Registration Number: SCB 211- 0094/2016

Course: BSc Biotechnology

Professor’s Name: Prof Wanyoike

Department: Botany

School: School of Biological Sciences

College: COPAS

Institution: Jomo Kenyatta University of Agriculture and Technology

Q1. Importance of IPR and how to secure one in Kenya.

Intellectual Property Right(IPR) rights are valuable assets for inventions. Stemming from its ability to provide a firm with competitive advantages, defining IPR as an asset aims to provide it the same protective rights as physical property. Obtaining such protective rights is critical as it prevents replication by potential competitors who are a serious threat in a web-based environment or the mobile technology sector, for example, an individual that owns IPR can realize value from it in several ways, namely through utilizing it internally—for its processes or provision of goods and services to customers—or sharing it externally. The latter can be achieved through legal mechanisms such as royalty rights (Baker, 2020). Some IPR rights are automatically safeguarded by IP law, but there are also other types of legal protection you can apply for.

Types of Intellectual Property

IP as an asset category can be divided into four distinct types—copyrights, trademarks, patents, and trade secrets (Waruingi, 2019).

Copyrights

Copyrights, among the most widely used types of IP, are a form of protection granted to the authors of original works of authorship, both published and unpublished. A copyright protects a tangible form of expression (such as a book, work of art, or music), rather than the idea or subject matter itself.

Trademarks

Trademarks are another common type of IP. A trademark, as defined by the Kenya Patent and Trademark Office (PTO), is any word, name, symbol, or device, or any combination, used, or intended to be used, in commerce to identify and distinguish the goods of one manufacturer or seller from goods manufactured or sold by others. While it is not as robust as the international protection regime for copyrights, the Trademark Law Treaty Implementation Act provides some international protection for Kenyan-registered trademarks.

Patents

As compared to other types of intellectual property, patents are among the most valuable, costly, and difficult to obtain. A patent is defined by the PTO as the grant of a property right to the inventor, providing the owner the right to exclude others from making, using, offering for sale, selling, or importing the invention. Patentable items may include objects or processes such as new technology or business methods, but excludes more abstract items such as web sites or ideas.

Sufficient documentation from the applicant coupled with verification of originality by the PTO is required before the grant can occur, and is then typically valid for 20 years from the date of application. Once received, a patent owner may grant licenses to others for use of the invention or its design and may charge a fee for such usage. Patents are valid only within the United States, including territories and possessions; however, 130 countries have agreed to honor patents across borders through instruments such as the Patent Cooperation Treaty (PCT).

Trade Secrets

Any idea or fact that is not disclosed by a business comprises the fourth type of intellectual property: trade secrets. A trade secret is a unique form of IP in that it does not have a defined time horizon—an issue could remain secret simply while filing for a patent, or it could remain closely guarded for the lifetime of the firm. A trade secret, by definition, is proprietary or business-related information that a company or individual uses or to which they possess exclusive rights.

To be deemed a trade secret, the information must meet several requirements: that it is genuine and not obvious, provides the owner with competitive or economic advantage, and thus has value, and is reasonably protected against disclosure. Examples of trade secrets include the aforementioned recipes, business methods, strategies, tactics, or any other piece of information that gives the business a competitive advantage.

Importance of IPR

• Sets innovations apart from competitors and be sold or licensed, providing an important revenue stream.
• It offers customers something new and different form an essential part of the invention of marketing or branding and can be used as security for the innovations.

The many aspects of an invention that can be protected include the innovation name and logo, designs, inventions, works of creative or intellectual effort, or trademarks that distinguish the innovation (Harrington, 2017).

How to Secure IPR in Kenya

1. Registration of copyrights, trademarks, and patents grant the exclusive rights to the creations, especially when it comes to the commercial gains of its use.
2. Registration of the business, product, or domain names that will help to secure the creations even if they are just in the planning stages before others could come up with a similar idea and cause some confusion.
3. Creation of confidentiality, non-disclosure or licensing contracts for employees and partners

Confidentiality, non-disclosure, or licensing contracts, that is crucial to protect the creations from leaking in public.

4. Implementation of security measures which plays an important role in preventing file corruption or hacking of the inventions.

References

Baker, B. K. (2020). Kenya’s Intellectual Property Bill, 2020, and Its Shortcomings in Adopting all Lawful TRIPS Public Health Flexibilities.

Harrington, J. (2017). Intellectual property and the life sciences in Kenya: Enforcement and access to medicines. In Research Handbook on Intellectual Property and the Life Sciences. Edward Elgar Publishing.

Waruingi, J. K. (2019). Intellectual property rights and their influence on ICT innovations in Kenya (Doctoral dissertation, University of Liverpool).

Q2. National Biosafety Law and its Regulatory Framework for Modern Biotechnology

The National Biosafety Authority (NBA) is a state corporation in Kenya mandated to ensure safety to human and animal health and provide adequate protection of the environment from harmful effects that may result from genetically modified organisms (GMOs) (Mbugua-Gitonga et al., 2016). The rapid progress of modern biotechnology has given rise to new legislative needs, to safeguard human health and the environment while at the same time taking advantage of the opportunities offered by biotechnology.

Recent years have seen important new legislation being adopted, and older law amended to respond to the new challenges. Considerable public debate has taken place over some of these technologies, in particular genetic engineering. Biotechnology has applications in four major industrial areas, including health care (medical), crop production and agriculture, non-food (industrial) uses of crops and other products (such as the biodegradable plastics, vegetable oil, biofuels), and environmental uses (Mbugua-Gitonga et al., 2016). While direct risks and benefits have been the main focus of that debate, other issues, social and ethical, have also been part of it.

Therefore, it seemed opportune not only to study how new legislation handles risk assessment and licensing for new technologies or products derived therefrom, but also how other considerations are taken into account, and how the general public is allowed to participate in the decision-making process (Sink et al., 2019). The important ethical dimension of modern biotechnology has been considered by FAO in its Ethics Series publication “Genetically modified organisms, consumers, food safety and the environment”, and by the Panel of Eminent Experts on Ethics in Food and Agriculture.

The Panel requested FAO to review the status of regulations in different countries concerning the application of biotechnology and GMOs. Purpose of this Law, consisting of 31 articles divided in VII, Sections, and 4 Annexes, is to regulate the activities aimed at the production of genetically modified organisms or genetically modified products and the establishment of an institutional competent body and defining its competences. Through this Law is intended to prohibit the direct release of genetically modified organisms or products into the environment or food, feed or vaccine, or manufacturing, import, or export GMOs.

The Authority was established under the provisions of the Biosafety Act No. 2, 2009 to regulate all activities involving GMOs in food, feed, research, industry, trade, and environmental release and it fulfills its mandate by ensuring and assuring the safe development, transfer, handling and use of GMOs in Kenya.

References

Mbugua-Gitonga, A., Mwaura, F., & Thenya, T. (2016). Biotechnology and Food Security in Kenya-An Assessment of Public Concerns on Biosafety, Public Health, and Religious Ethics. Journal of Advances in Biology & Biotechnology, 1-13.

Sink, K. J. S., Majiedt, P. S., Franken, M. L., Adams, L., Dunga, L. V., Perschke, M., … & Gqaleni, M. C. S. (2019). Annexure 3: Pressure and Ecosystem Classification References. National Biodiversity Assessment 2018 Supplementary Material.

Q3. Recent Trends in Biotechnology

Modern biotechnology focuses primarily on medicine. In this field, small startups, multinational pharmaceutical companies, and government research agencies develop new treatment options for rare and complex diseases, as well as genetic tests to better identify inherited diseases. Other fields of biotechnology include agriculture, alternative energy, and environmental science.

Students who graduate with a master’s degree in biotechnology move on to a wide range of careers in biotech, such as biomedical engineering, clinical technology, microbiology, biomanufacturing, epidemiology, and genetic counseling.

Recent trends include:

1. The Use of Next-Generation Computing Technology

Technology has always been at the heart of biotech (Ngolong et al., 2020). The emergence of advanced computing technology such as machine learning and artificial intelligence enables companies to expand the scope and scale of their research and improve efficiency in the manufacturing process—both of which reduce the time it takes for biotech firms to bring new products to market.

In medicine, for example, the ability to analyze large data sets helps drugmakers identify treatments based on the cause of a disease. This has the potential to reduce the $2.6 billion price tag and the 90 percent failure rate for developing new drugs.

Besides, the evolution of cloud computing technology has removed a barrier for many innovations in biotech. The ability to run applications through the cloud allows companies to store and analyze data without buying expensive computer hardware. This benefits early-stage startups, which try to limit operating expenses as much as possible, but it also helps larger and more established companies, as it makes it easier and cheaper to allocate resources for new projects.

2. Increased Stakeholder Collaboration

Another benefit of cloud computing is its ability to support collaboration among stakeholders that represent different organizations, whether it’s multinational firms, smaller companies, academic institutions, or government research organizations. Software tools that support communication, data sharing, and virtual meetings enable groups to work together regardless of where they are located—opening the research process to a much larger group of stakeholders.

Increased collaboration does pose a potential challenge to biotechnology professionals. With larger teams working on projects, and with some projects taking many years to receive regulatory approval or achieve a return on investment, individuals and the organizations they represent need to consider intellectual property protection for the innovations they are developing. Otherwise, they may not financially benefit from the products they create.

3. The Evolution of Clinical Trials

A range of technological advances has transformed the clinical trial process. Clinical trials used to be a very manual process, with trial participants going to a clinic in-person to receive treatment and recording their symptoms and side effects on paper. Also, drugmakers typically needed to recruit a large number of participants to get the right sample size—or they needed to invest heavily in marketing resources to recruit the right patients to treat a rare condition.

Today, the clinical trial has been heavily digitized, enabling biotech companies to test treatments on more patients in less time. In a notable example, in November 2019 the medical genetics company known as Invitae announced a trial with Apple Watch that brings together biometric data collected from the wristwatch and the results of genetic tests to determine the genes that cause cardiovascular disease. This makes the trial accessible to a larger number of people, and it helps researchers quickly exclude patients who do not meet the criteria for the trial.

As noted, machine learning technology also holds promise for the future of the clinical trial. Biotech companies can quickly analyze data from current trials to predict the effectiveness of treatments down to a molecular level; they can also revisit data from previous trials to see if anything may have been missed, or if there may be new or different uses for an existing drug.

4. Growth in Personalized Treatment of Rare Diseases

The reduced cost of genetic sequencing—from $2.7 billion for the Human Genome Project in 1990 to less than $300 today, and potentially less than $100 in the future—allows for much more extensive screening of trial participants and targeting of interventions. This has enabled the development of personalized treatment plans and targeted therapies, which are more effective than less-specific therapies because they focus on a patient’s genetic and molecular makeup.

Cancer treatment is a key area of focus for targeted therapies. One prominent example is blood cancer such as leukemia, where a treatment called CAR T-cell therapy targets a patient’s immune cells and, in the words of the National Cancer Institute, the immune system will “attack tumors.

5. Demand for Higher Agricultural Yields

According to the United Nations, the global population is set to increase by more than 25 percent in the next 30 years, from 7.7 billion in 2019 to 9.7 billion in 2050. A growing population leads to a higher demand for food, both for people and for livestock, and it also puts pressure on the use of land as urban areas expand onto lands used for farming.

These global trends provide opportunities for biotechnology to improve agricultural yields (Szuplewska et al., 2020). Gene editing, for example, could produce varieties of wheat or corn that can grow in harsher conditions or produce more grain in a smaller area than other crop varieties while providing the same nutritional value. Besides, the development of biological pesticides has the potential to protect crops without the use of harmful chemicals or environmental damage.

6. The Emergence of Value-Based Pricing Models

Under value-based pricing agreements, a buyer and a seller link payments to a specific value achieved as opposed to a volume of sales. These agreements are meant to align the incentives between the manufacturers and purchasers of a product—they often require a different pricing model than traditional contracts, and they require clear language to explain terms and conditions.

Value-based contracts recognize that both parties are taking a financial risk in the use of a new product (Brilmayer et al., 2020). In healthcare, for example, a value-based pricing model might stipulate that a drug maker receives a lower payment unless a medication achieves measurable improvements when compared to other treatment options. In environmental science, value-based pricing could be targeted to the percent of waste cleaned through the use of microorganisms.

References

Brilmayer, R., Förster, C., Zhao, L., & Andrieu-Brunsen, A. (2020). Recent trends in nanopore polymer functionalization. Current Opinion in Biotechnology, 63, 200-209.

Ngolong Ngea, G. L., Yang, Q., Castoria, R., Zhang, X., Routledge, M. N., & Zhang, H. (2020). Recent trends in detecting, controlling, and detoxifying of patulin mycotoxin using biotechnology methods. Comprehensive Reviews in Food Science and Food Safety.

Szuplewska, A., Kulpińska, D., Dybko, A., Chudy, M., Jastrzębska, A. M., Olszyna, A., & Brzózka, Z. (2020). Future applications of MXenes in biotechnology, nanomedicine, and sensors. Trends in biotechnology, 38(3), 264-279.