Last week the Senate Judiciary Committee held a hearing, Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition, that explored whether changes to the pharmaceutical patent process could help lower drug prices. The committee’s goal was to evaluate various legislative proposals that might facilitate the entry of cheaper generic drugs, while also recognizing that strong patent rights for branded drugs are essential to incentivize drug innovation. As Committee Chairman Lindsey Graham explained:

One thing you don’t want to do is kill the goose who laid the golden egg, which is pharmaceutical development. But you also don’t want to have a system that extends unnecessarily beyond the ability to get your money back and make a profit, a patent system that drives up costs for the average consumer.

Several proposals that were discussed at the hearing have the potential to encourage competition in the pharmaceutical industry and help rein in drug prices. Below, I discuss these proposals, plus a few additional reforms. I also point out some of the language in the current draft proposals that goes a bit too far and threatens the ability of drug makers to remain innovative.

1. Prevent brand drug makers from blocking generic companies’ access to drug samples. Some brand drug makers have attempted to delay generic entry by restricting generics’ access to the drug samples necessary to conduct FDA-required bioequivalence studies. Some brand drug manufacturers have limited the ability of pharmacies or wholesalers to sell samples to generic companies or abused the REMS (Risk Evaluation Mitigation Strategy) program to refuse samples to generics under the auspices of REMS safety requirements. The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2019 would allow potential generic competitors to bring an action in federal court for both injunctive relief and damages when brand companies block access to drug samples. It also gives the FDA discretion to approve alternative REMS safety protocols for generic competitors that have been denied samples under the brand companies’ REMS protocol. Although the vast majority of brand drug companies do not engage in the delay tactics addressed by CREATES, the Act would prevent the handful that do from thwarting generic competition. Increased generic competition should, in turn, reduce drug prices.
2. Restrict abuses of FDA Citizen Petitions. The citizen petition process was created as a way for individuals and community groups to flag legitimate concerns about drugs awaiting FDA

A unilateral mistake in a contract can occur through errors in wording, legal concerns or facts that are in conflict within the document that can lead to a full cancellation between all parties involved in the situation. In these circumstances between client and customer, a cancellation is often the best way to progress forward.

The Unilateral Mistake

Most contract mistakes are because of errors made in the language that affect the relationship. These issues can stem from a single wrong word that invalidates a certain dealing or something that should be fact but is really speculation. The responsibilities of both parties should remain clear and narrow of purpose without vague or confusing wording. Mistakes in the contract that cause confusion can lead to difficulties and problems later. A unilateral mistake is also something that only one party suffers while the other does not share this issue and may not need to worry about it unless the contract cancels.

The One Party

Unilateral mistakes affect one party in the contract relationship because of problems with the subject matter of the document or provisions in the agreement. These mistakes are common, but many agreements may remain effective without noticing the mistakes until a later point. However, while one party usually holds the responsibilities to correct such issues or find them to amend the document, there are times when there is a mutual mistake that can invalidate the contract before the relationship even begins. It is important to have a lawyer look over the provisions and terms to help avoid these serious complications.

Unfair Advantage

When only one party shares the blame for the mistake made in the contract, it could lead to an imbalance of power between the two connected by the legal agreement. This is an unfair advantage that could affect business interactions seriously. If the contract started with this unilateral mistake and is the basis for the relationship between the two parties, it could lead to a contract remedy. These exist in contract rescission or reformation of the agreement. While the one side may want the advantage, it can end with a contract that is void rather than a continued association.

The Minute Details

Unilateral mistakes often are more minor and minute in the details and provisions rather than grand and apparent mistaken issues. One aspect could regard a word that has multiple meanings and that is left open …

Law 1943 of 2018, known as the “financing law”, is nothing more than a tax reform that aims to achieve greater tax collection to address the fiscal deficit, however, the Government has stated that this law seeks to encourage private investment and to boost the economic development of the country, through the generation of jobs.

Law 1943 of 2018, known as the “financing law”, is nothing more than a tax reform that aims to achieve greater tax collection to address the fiscal deficit, however, the Government has stated that this law seeks to encourage private investment and to boost the economic development of the country, through the generation of jobs.

In order to illustrate our readers, we have decided to mention some of the changes in taxes, which the business sector must face, and those which we consider occupy a higher percentage in business activities.

Equity Tax: it is created for the years 2019, 2020 and 2021. The equity tax is generated by having a liquid wealth, as of January 1 of 2019, whose value is equal to, or greater than, $5,000 million Colombian pesos. The rate will be 1% for each year. The tax is payable on January 1 of 2019, 2020 and 2021.
This tax will be applied to:

Natural persons, illiquid inheritances and income tax payers. Although the law does not expressly mention legal persons, it must be interpreted as meaning that they are taxpayers of income tax and, therefore, are also subject to wealth/equity tax.
Natural persons, nationals or foreign non-residents, regarding to the patrimony directly possessed in Colombia, or indirectly possessed through permanent establishments, except for the exceptions of international treaties and law. In the latter case, the formal duty, to declare, corresponds to the branches or permanent establishments. Foreign entities that do not declare income, and that own assets in Colombia other than shares, accounts receivable, and/or portfolio investments, indicated in the law, such as real estates, yachts, boats, boats, works of art, aircrafts or mining or oil rights, that is to say, foreign entities that do not declare income and have assets in Colombia such as shares, accounts receivable and/or portfolio investments, are not subject to this tax, but if they have other taxed assets that exceed 5,000 million Colombian pesos, then they will be subject to this tax.
Illiquid successions of non-resident causers at the time of death, with respect to …