English competition law before 1900 developed over the course of many centuries beginning in the medieval period. That development reflected changes in political conditions, economic theories, and broader cultural values. English competition law mirrored the historical movements in England from the medieval ideal of fair prices and just wages to 16th and 17th century nation state mercantilism to the 18th and 19th century Industrial Revolution, laissez faire capitalism and freedom of contract. The development of English competition law is rich in insights for modern antitrust issues like the adaptability of case law and legislation to changing economic conditions, the role of economic theories in the formulation of legal rules, and the role of political and social values in competition policy.
Today the predominant if not exclusive emphasis on economics in the application of modern antitrust laws has resulted in a quasi-regulatory system far more technical, specialized and narrowly focused than the case making of generalist English common law judges. Modern antitrust law adapts well to changes in economic theories and conditions but it is less adaptable than English common law to shifts in political and social values. This lack of adaptability is viewed by most commentators as a beneficial insulation of decision-making from political or social influences. Proponents of non-economic policy concerns (like fear of concentration for political or social reasons), on the other hand, are forced to formulate their concerns in economic terms because of the prevailing view that only economics counts in antitrust. They would have had an easier task under the English common law.For a trip to the dark side - one requiring substantive intervention by regulators - I note the TGA's statement last month regarding encapsulated placentas and other placentophagy.
The TGA states
The TGA is aware of several websites offering expectant mothers services for the preparation of the placenta for consumption; a practice known as placentophagy. We are advising expectant mothers to be aware of the potential risks associated with placenta consumption.
A range of preparation methods are offered, including cooking or drying and encapsulating, with the intention for you, family members or others to consume the placental material after childbirth. More rarely, websites may also offer placenta or placenta-containing medicines made from other human sources. Often these services are offered by a midwife or doula; generally people who provide support and advice to women during pregnancy, birth and after birth.
There is currently no evidence to support the claims of health benefits associated with consuming human placenta, and the broader risks are unknown.Quite so, given that processes for preparing the placenta for ingestion, through for example steaming, are likely to substantially reduce pharmacologically active compounds.
The TGA goes on to refer to 'Potential health risks for consumers'
As an expectant or new mother, you should be aware of the potential health risks associated with the preparation and consumption of your placenta.
Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if your placenta is ingested by another person or you ingest another person's placenta.
Generally the placenta is discarded after childbirth and as a result there are no regulations on how placental material is to be stored and prepared to ensure it is safe for consumption.And the legal framework?
Potential legal implications for service providers
Prepared placenta products, including in capsule or tablet form, are often associated with claims that consumption will have some therapeutic benefit for mothers and/or children, for example, improving mood, energy levels and milk production.
Such claims run the risk of bringing these products under the regulatory framework that covers 'biologicals', governed by legislation that regulates therapeutic goods. This includes the Commonwealth Therapeutic Goods Act 1989 and corresponding legislation in several states and territories.
Under the Therapeutic Goods Act 1989, it is an offence to make therapeutic biological products without holding the appropriate licence. The Regulatory framework for biologicals page provides further information on licensing requirements. The licence provisions are designed to ensure that the product is manufactured in conditions that will minimise risk to the user. Products that are classed as therapeutic goods must also be approved by the TGA to ensure they are of good quality, safe and effective for the intended purpose.
These laws also contain substantial penalties, including criminal sanctions, for people making or supplying unapproved biological products, and prohibit the advertising of biological products to the public.
Depending on the circumstances and the claims made in relation to the product, these laws could also apply to the midwife, doula or even the mother involved.2014 comments by the UK Food Standards Agency and some research are noted here.
