Authors

Sarah Gabriele is a second-year Master of Bioethics candidate at Harvard Medical School. She obtained her law degree from the University of Trento (Italy) and an LL.M. from the Washington University in St. Louis. After graduating from law school, she worked at Hogan Lovells in their Milan office, specializing in pharmaceutical patent litigation. Currently, she is a student fellow with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and a research specialist at PORTAL, in the Division of Pharmacoepidemiology and Pharmacoeconomics of Harvard Medical School and Brigham and Women’s Hospital.
EU flags in front of European Commission in Brussels.

European Union Debates Further Patent Protections

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By Sarah Gabriele

In line with the European Union’s efforts to strengthen the single market and as part of the Single Market Strategy presented by the European Commission in 2015, the European Commission has presented a proposed regulation regarding the Unitary Supplementary Protection Certificate (“USPC”). The proposed regulation will extend patent protections across the Union, creating a stronger right for brand-name pharmaceutical companies. However, the proposed regulation, in line with the most recent case law of the European Court of Justice, further strengthens the limit for pharmaceutical companies to obtain only one certificate per product per patent holder.

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Vaccine and syringe in front of EU flag.

The European Commission’s New Compulsory Licensing Proposal: A Step Forward?

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By Sarah Gabriele

On April 27, 2023, the European Commission proposed new legislation that would allow companies to make drugs without the patent holder’s consent in emergency situations. The proposed legislation constitutes a step forward in the European Union’s effort to harmonize patent law in the Union, after the establishment of Unitary Patents and the European Patent Court.

In its proposal, the EU Commission acknowledges that intellectual property rights, and, in particular, patent rights play an important role in access to medicine, especially during public health crises. The COVID-19 crisis demonstrated how the need for protecting and incentivizing innovation clashed with the need to make products widely available. To solve this tension, the Commission recognizes that patent law already offers a solution: compulsory licensing.

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Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

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By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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Interior of an Italian pharmacy. Pharmacist looks for medicines to sell to the customer. Puglia, Italia - 29/01/2009.

Falling Revenue Means Pharmacies in Italy Aren’t Keeping up with Other EU Countries

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By Gianluca Ceci and Sarah Gabriele

In 2021, the total revenue of Italian pharmacies dropped by 4% compared to 2015, despite Italy being the fifth largest country in the EU for pharmaceutical expenditures. The main reasons: the reabsorption of demand and small pharmacy size, as well as the failure to innovate the current business model.

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Black and white photo of a woman with phone in hand; phone has color retouched image of her face on it.

The Filter Effect: What Does Comparing Our Bodies on Social Media Do to Our Health?

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By Sarah Gabriele

Filters on social media apps such as Instagram and TikTok are great to take silly pictures alone and with friends, and they often give us a good laugh. However, as Dr. Christine Stabler from Penn Medicine writes, they also create an illusion, a perfection that we struggle to live up to every day. This is the case even if almost everyone is well aware that pictures are filtered and carefully selected, and that pictures do not always represent reality.

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see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

What Happened to the COVID-19 Vaccine Patent Waiver?

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By Sarah Gabriele

In June 2022, after almost two years of debate over a potential COVID-19 vaccine patent waiver, the World Trade Organization adopted the Ministerial Decision on the TRIPS Agreement (“WTO Decision”), which provided for a partial waiver of intellectual property rights.

More specifically, the WTO Decision waived patent rights on vaccines and allowed for the use of protected clinical trial data for regulatory approval of vaccines. However, after almost four months since the adoption of the WTO Decision, there is still a large gap in vaccination rates worldwide.

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Secretary Giorgia Meloni talks during a Fratelli D'italia party electoral meeting tour towards the 25 September vote.

Abortion Rights Under Siege in Italy Post-Dobbs

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By Sarah Gabriele

The U.S. Supreme Court’s decision to overturn the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization has had an impact and influence far beyond U.S. borders, with right-wing politicians in Italy campaigning on stricter abortion laws in the recent election of September 25, 2022. And now that the far right has reached the majority in both the Italian Parliament and Senate, access to abortion in Italy could soon face additional restrictions.

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